Comparison Study of Transversus Abdominal Plane, Paravertebral and Epidural Blocks in Laparoscopic Colectomy

Sponsor
Duke University (Other)
Overall Status
Terminated
CT.gov ID
NCT02164929
Collaborator
(none)
17
1
4
14.9
1.1

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effectiveness of transversus abdominal plane (TAP) block, thoracic epidural or paravertebral block (PVB) for controlling postoperative pain when compared with opioid you self-administer in your vein using a PCA device. The primary outcome will be postoperative opioid consumption within 24 hours after surgery. A total of 120 subjects will be randomized in a 1:1:1:1 ratio to receive a TAP block, PVB, TEA or no block (PCA alone).Patients in all groups will be cared for using an established enhanced recovery after surgery (ERAS) pathway incorporating a multimodal analgesic regimen using IV acetaminophen and postoperative PCA fentanyl.

Condition or Disease Intervention/Treatment Phase
  • Procedure: TAP block
  • Procedure: Epidural
  • Procedure: Paravertebral block
  • Drug: Acetaminophen 1g IV
  • Drug: Dexamethasone 4mg
  • Drug: Midazolam up to 2mg
  • Drug: Propofol 1-2.5 mg/kg
  • Drug: Sevoflurane to keep a bispectral index of between 40-60
  • Drug: Local infiltration with 10 mL of plain ropivacaine 0.25%
  • Drug: Lidocaine
  • Drug: Epinephrine
  • Drug: Hydromorphone
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized, Single-Blind Study to Evaluate the Efficacy of Transversus Abdominis Plane Versus Paravertebral Regional Blockade in Patients Undergoing Laparoscopic Colectomy
Study Start Date :
Dec 1, 2013
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Paravertebral block

Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).

Procedure: Paravertebral block
Other Names:
  • PVB
  • Drug: Acetaminophen 1g IV

    Drug: Dexamethasone 4mg

    Drug: Midazolam up to 2mg

    Drug: Propofol 1-2.5 mg/kg

    Drug: Sevoflurane to keep a bispectral index of between 40-60

    Drug: Local infiltration with 10 mL of plain ropivacaine 0.25%

    Active Comparator: TAP block

    Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).

    Procedure: TAP block
    Other Names:
  • Transversus abdominus plane block
  • Drug: Acetaminophen 1g IV

    Drug: Dexamethasone 4mg

    Drug: Midazolam up to 2mg

    Drug: Propofol 1-2.5 mg/kg

    Drug: Sevoflurane to keep a bispectral index of between 40-60

    Drug: Local infiltration with 10 mL of plain ropivacaine 0.25%

    Active Comparator: Epidural

    An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.

    Procedure: Epidural
    Other Names:
  • Thoracic Epidural Anesthesia (TEA)
  • Drug: Acetaminophen 1g IV

    Drug: Dexamethasone 4mg

    Drug: Midazolam up to 2mg

    Drug: Propofol 1-2.5 mg/kg

    Drug: Sevoflurane to keep a bispectral index of between 40-60

    Drug: Local infiltration with 10 mL of plain ropivacaine 0.25%

    Drug: Lidocaine
    1.5% lidocaine

    Drug: Epinephrine
    1:200,000 epinephrine

    Drug: Hydromorphone
    400-800 mcg Hydromorphone will be given preoperatively

    Active Comparator: No block (PCA alone)

    Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure

    Drug: Acetaminophen 1g IV

    Drug: Dexamethasone 4mg

    Drug: Midazolam up to 2mg

    Drug: Propofol 1-2.5 mg/kg

    Drug: Sevoflurane to keep a bispectral index of between 40-60

    Drug: Local infiltration with 10 mL of plain ropivacaine 0.25%

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative Opioid Consumption [24 hours after surgery]

      If opioid other than fentanyl is used, the dose will be converted to morphine equivalent.

    Secondary Outcome Measures

    1. Pain Scores [Participants will be followed for the duration of hospital stay, an estimated 1 week]

      Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where "0" represents no pain and "10" represents worst pain ever, at 30, 60, 90, 120 min and every 6 hours for 24 hours and every 12 hours for 48 hours and once a day thereafter until discharge. Data were collected at the indicated time points and an average pain score was calculated.

    2. Quality of Recovery [72 hours]

      Quality of Recovery Score (QoR-15) is measured on a scale of 0-150 (0=poor, 150 = excellent). Scores were collected daily for 72 hours and then averaged.

    3. Complications as Measured by a Modified Postoperative Morbidity Survey (MPMS) [Participants will be followed for the duration of hospital stay, an estimated 1 week]

      Complications using a Modified Postoperative Morbidity Survey (MPMS)

    4. Time to First Bowel Movement [Participants will be followed for the duration of hospital stay, an estimated 1 week]

    5. Opioid Related Side Effects [Participants will be followed for the duration of hospital stay, an estimated 1 week]

      Occurrence and duration of opioid related adverse events including postoperative nausea and vomiting (PONV); pruritus, urinary retention, confusion, sedation and respiratory depression at the above time points.

    6. Time to First Ingestion of Solid Food [Participants will be followed for the duration of hospital stay, an estimated 1 week]

    7. Number of Epidural-related Side Effects [Participants will be followed for the duration of hospital stay, an estimated 1 week]

    8. Length of Stay [Participants will be followed for the duration of hospital stay, an estimated 1 week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    • Male or female, ≥ 18 years of age

    • Patients scheduled to undergo laparoscopic colectomy without stoma under general anesthesia

    • American Society of Anesthesiology (ASA) Physical Class 1-3.

    Exclusion Criteria:
    • Open colectomy

    • Perineal resection

    • Stoma formation

    • Patients with a contraindication to TEA or regional anesthesia.

    • Pregnancy, nursing, or planning to become pregnant during the study or within one month.

    • Long-acting opioid medication within 3 days.

    • Any opioid medication within 24 hours.

    • Body weight less than 50 kilograms (~110 pounds)

    • Uncontrolled anxiety, schizophrenia, or other psychiatric disorder

    • Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postoperative course.

    • Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.

    • Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.

    • Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial, such as: debilitating diseases, acute illnesses, hypotension, partial or complete conduction block, impaired cardiac function, untreated hypertension, advanced arteriosclerotic heart disease, cerebral vascular insufficiency, pre-existing abnormal neurological or neuromuscular disease (e.g., epilepsy, myasthenia gravis), advanced liver disease, severe renal impairment, advanced diabetes, comorbid conditions associated with an immunocompromised status, such as blood dyscrasias, HIV/AIDS, or recent chemotherapy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Medical Center Durham North Carolina United States 27701

    Sponsors and Collaborators

    • Duke University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT02164929
    Other Study ID Numbers:
    • Pro00047810
    First Posted:
    Jun 17, 2014
    Last Update Posted:
    Sep 25, 2017
    Last Verified:
    Jan 1, 2017

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Of the 17 patients that consented, one patient withdrew before randomization
    Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
    Arm/Group Description Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
    Period Title: Overall Study
    STARTED 4 3 5 4
    COMPLETED 3 3 4 2
    NOT COMPLETED 1 0 1 2

    Baseline Characteristics

    Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone) Total
    Arm/Group Description Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% Total of all reporting groups
    Overall Participants 4 3 4 4 15
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    55.5
    (8.5)
    51
    (15)
    57.75
    (6.6)
    52
    (21.9)
    54.2
    (12.9)
    Sex: Female, Male (Count of Participants)
    Female
    2
    50%
    1
    33.3%
    2
    50%
    2
    50%
    7
    46.7%
    Male
    2
    50%
    2
    66.7%
    2
    50%
    2
    50%
    8
    53.3%

    Outcome Measures

    1. Primary Outcome
    Title Postoperative Opioid Consumption
    Description If opioid other than fentanyl is used, the dose will be converted to morphine equivalent.
    Time Frame 24 hours after surgery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
    Arm/Group Description Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
    Measure Participants 3 3 4 2
    Mean (Standard Deviation) [mcg]
    734
    (422)
    666
    (474)
    125
    (50)
    1017.5
    (484)
    2. Secondary Outcome
    Title Pain Scores
    Description Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where "0" represents no pain and "10" represents worst pain ever, at 30, 60, 90, 120 min and every 6 hours for 24 hours and every 12 hours for 48 hours and once a day thereafter until discharge. Data were collected at the indicated time points and an average pain score was calculated.
    Time Frame Participants will be followed for the duration of hospital stay, an estimated 1 week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
    Arm/Group Description Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
    Measure Participants 3 3 4 2
    Mean (Standard Deviation) [Units on a scale]
    4.66
    (1.15)
    2.66
    (1.52)
    1.75
    (1.25)
    6
    (2.82)
    3. Secondary Outcome
    Title Quality of Recovery
    Description Quality of Recovery Score (QoR-15) is measured on a scale of 0-150 (0=poor, 150 = excellent). Scores were collected daily for 72 hours and then averaged.
    Time Frame 72 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
    Arm/Group Description Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
    Measure Participants 3 3 4 2
    Mean (Standard Deviation) [Units on a scale]
    89.5
    (10.6)
    117
    (23.3)
    115.5
    (0.7)
    99
    (17.6)
    4. Secondary Outcome
    Title Complications as Measured by a Modified Postoperative Morbidity Survey (MPMS)
    Description Complications using a Modified Postoperative Morbidity Survey (MPMS)
    Time Frame Participants will be followed for the duration of hospital stay, an estimated 1 week

    Outcome Measure Data

    Analysis Population Description
    Data not collected
    Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
    Arm/Group Description Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
    Measure Participants 0 0 0 0
    5. Secondary Outcome
    Title Time to First Bowel Movement
    Description
    Time Frame Participants will be followed for the duration of hospital stay, an estimated 1 week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
    Arm/Group Description Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
    Measure Participants 3 3 4 2
    Mean (Standard Deviation) [days]
    1
    (1.4)
    2
    (0.7)
    1
    (0.8)
    2
    (0)
    6. Secondary Outcome
    Title Opioid Related Side Effects
    Description Occurrence and duration of opioid related adverse events including postoperative nausea and vomiting (PONV); pruritus, urinary retention, confusion, sedation and respiratory depression at the above time points.
    Time Frame Participants will be followed for the duration of hospital stay, an estimated 1 week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
    Arm/Group Description Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
    Measure Participants 3 3 4 2
    Number [side effects]
    0
    0
    0
    0
    7. Secondary Outcome
    Title Time to First Ingestion of Solid Food
    Description
    Time Frame Participants will be followed for the duration of hospital stay, an estimated 1 week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
    Arm/Group Description Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
    Measure Participants 3 3 4 2
    Mean (Standard Deviation) [Days]
    1
    (0)
    2
    (0.7)
    0.75
    (0.5)
    1.5
    (0.7)
    8. Secondary Outcome
    Title Number of Epidural-related Side Effects
    Description
    Time Frame Participants will be followed for the duration of hospital stay, an estimated 1 week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
    Arm/Group Description Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
    Measure Participants 3 3 4 2
    Number [Number of side effects]
    0
    0
    0
    0
    9. Secondary Outcome
    Title Length of Stay
    Description
    Time Frame Participants will be followed for the duration of hospital stay, an estimated 1 week

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
    Arm/Group Description Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
    Measure Participants 3 3 4 2
    Mean (Standard Deviation) [Days]
    2.66
    (0.57)
    4.33
    (3.21)
    4
    (1.41)
    3.5
    (0.7)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Paravertebral Block TAP Block Epidural No Block (PCA Alone)
    Arm/Group Description Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25% An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
    All Cause Mortality
    Paravertebral Block TAP Block Epidural No Block (PCA Alone)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Paravertebral Block TAP Block Epidural No Block (PCA Alone)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/4 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%)
    Other (Not Including Serious) Adverse Events
    Paravertebral Block TAP Block Epidural No Block (PCA Alone)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/4 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Timothy Miller, MD
    Organization Duke University Medical Center
    Phone
    Email timothy.miller2@duke.edu
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT02164929
    Other Study ID Numbers:
    • Pro00047810
    First Posted:
    Jun 17, 2014
    Last Update Posted:
    Sep 25, 2017
    Last Verified:
    Jan 1, 2017