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Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients

Sponsor
Inova Health Care Services (Other)
Overall Status
Terminated
CT.gov ID
NCT03638635
Collaborator
(none)
63
Enrollment
6
Locations
2
Arms
8.1
Actual Duration (Months)
10.5
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The transversus abdominis plane (TAP) block can be used to reduce pain in patients who get abdominal surgery. TAP blocks are given with a local anesthetic. The purpose of this study is to compare pain medication usage after surgery between two different types of local anesthetic: liposomal bupivacaine and standard bupivacaine.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Pain control is a factor that is central to the surgical patient's postoperative experience. Opioid pain medications are a mainstay of postoperative pain management. However, these have several adverse effects.

Multimodal pain regimens to minimize opioid use have become central to enhanced recovery after surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is one intervention that contributes to this regimen. Traditionally, TAP blocks are performed with local anesthetics such as bupivacaine. More recently, these have also been performed with liposomal bupivacaine, whose duration of action is much greater than regular bupivacaine (96 hours versus 8-9 hours, respectively).

In this study, postoperative opioid usage will be compared between patients receiving regular bupivacaine and liposomal bupivacaine.

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are randomized to receive either standard bupivacaine or liposomal bupivacaine.Participants are randomized to receive either standard bupivacaine or liposomal bupivacaine.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The participant and the floor nursing staff recording pain scores will be blinded to the assigned intervention.
Primary Purpose:
Supportive Care
Official Title:
TAP Blocks Performed With Bupivacaine Versus Liposomal Bupivacaine in Colorectal Surgery Patients: A Prospective, Cluster Randomized Trial
Actual Study Start Date :
May 14, 2018
Actual Primary Completion Date :
Jan 16, 2019
Actual Study Completion Date :
Jan 16, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard Bupivacaine

Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.

Drug: Bupivacaine
Abdominal injection of bupivacaine into fascial layer.
Other Names:
  • Marcaine

    		•
    Experimental: Bupivacaine Liposome

    Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.

    Drug: Bupivacaine liposome
    Abdominal injection of bupivacaine liposome into fascial layer.
    Other Names:
  • Exparel

    		•

    Outcome Measures

    Primary Outcome Measures

    1. In-hospital Postoperative Opioid Consumption [up to postoperative day 3 at 1 pm]

      Daily overall opioid use recorded as morphine equivalents

    Secondary Outcome Measures

    1. Pain Score [Approximately every 6 hours through postoperative day 3 by 1 pm]

      Recorded on a scale of 0 (No pain) to 10 (Worst possible pain)

    2. Time to Patient Mobilization [From time of surgery until time of first patient ambulation post op. Assessed until date of discharge (usually up to 4 days after surgery).]

      Number of days from day of surgery until patient mobilization

    3. Time to Return of Bowel Function [From time of surgery until first time patient passes gas or stool per rectum or into ostomy bag. Assessed until date of discharge (usually up to 4 days after surgery).]

      Number of days from time of surgery until return of bowel function

    4. Time to Clear Liquid Diet [From time of surgery until first time patient tolerates clear liquids without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).]

      Number of days from time of surgery until patient tolerates clear liquid diet

    5. Time to Low Fiber Diet [From time of surgery until first time patient tolerates a low fiber diet without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).]

      Number of days from day of surgery until patient tolerates low fiber diet

    6. Length of Stay [Date of surgery to date of discharge (usually up to 4 days after surgery).]

      Total postoperative hospital stay in days

    7. In-hospital Antiemetic Use [Time of transfer to post operative suite to time of discharge (usually up to 4 days after surgery).]

      Amount of ondansetron patient required postoperatively during hospital stay, in milligrams

    8. Complications [Within 30 days of surgery]

      Patient suffered a complication (infection, small bowel obstruction, dehydration, deep vein thrombosis/pulmonary embolism, anastomotic leak, cardiac arrest, stroke, sepsis) after surgery

    9. Readmissions [Within 30 days of hospital discharge]

      Patient readmitted to hospital after discharge

    10. Mortality [Within 30 days of surgery]

      Patient death after surgery

    11. Hospitalization Costs [From date of this surgical admission to date of this surgical discharge (usually up to 4 days after surgery).]

      Total hospitalization costs per patient per this surgical encounter

    Eligibility Criteria

    Criteria

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

    • 18 years of age or older

    • Undergoing elective colectomy by surgeons of Fairfax Colon and Rectal Surgery

    Exclusion Criteria:

    • Allergic to local anesthetics

    • Unable to provide consent

    • Pregnant

    • On opioids at home chronically (Patients previously on a regular opioid regimen would need to be opioid-free for a period of 1 year for inclusion in the study)

    • Undergoing emergent operations

    • Undergoing loop ileostomy reversal

    • Undergoing abdominoperineal resection, pelvic exenteration, or perineal rectal prolapse repairs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fairfax Colon & Rectal Surgery, Alexandria Office Alexandria Virginia United States 22304
    2 Fairfax Colon & Rectal Surgery, Fairfax-Prosperity Office Fairfax Virginia United States 22031
    3 Fairfax Colon & Rectal Surgery, Fair Oaks Office Fairfax Virginia United States 22033
    4 Inova Fairfax Medical Campus Falls Church Virginia United States 22042
    5 Fairfax Colon & Rectal Surgery, Loudoun Office Lansdowne Town Center Virginia United States 20176
    6 Fairfax Colon & Rectal Surgery, Reston Office Reston Virginia United States 20190

    Sponsors and Collaborators

    • Inova Health Care Services

    Investigators

    • Principal Investigator: Donald Colvin, MD, Inova Health Care System

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Inova Health Care Services
    ClinicalTrials.gov Identifier:
    NCT03638635
    Other Study ID Numbers:
    • 17-2725
    First Posted:
    Aug 20, 2018
    Last Update Posted:
    Sep 9, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Inova Health Care Services
    Bupivacaine
    Exparel
    TAP Block
    Opioids
    Narcotics
    ERAS
    Additional relevant MeSH terms:
    Pain, Postoperative
    Bupivacaine

    Study Results

    Participant Flow

    Recruitment Details Patients were approached for consent in the hospital postoperatively to request the use of their data for research purposes.
    Pre-assignment Detail
    Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
    Arm/Group Description Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine: Abdominal injection of bupivacaine into fascial layer. Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.
    Period Title: Initial Hospitalization
    STARTED 39 24
    COMPLETED 39 22
    NOT COMPLETED 0 2
    Period Title: Initial Hospitalization
    STARTED 39 22
    COMPLETED 0 0
    NOT COMPLETED 39 22

    Baseline Characteristics

    Arm/Group Title Standard Bupivacaine Bupivacaine Liposome Total
    Arm/Group Description Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine: Abdominal injection of bupivacaine into fascial layer. Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer. Total of all reporting groups
    Overall Participants 39 24 63
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    60.97
    (16.25)
    60.04
    (17.36)
    60.63
    (16.54)
    Sex: Female, Male (Count of Participants)
    Female
    22
    56.4%
    13
    54.2%
    35
    55.6%
    Male
    17
    43.6%
    11
    45.8%
    28
    44.4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    3
    7.7%
    2
    8.3%
    5
    7.9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    3
    7.7%
    2
    8.3%
    5
    7.9%
    White
    30
    76.9%
    20
    83.3%
    50
    79.4%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    3
    7.7%
    0
    0%
    3
    4.8%
    Region of Enrollment (Count of Participants)
    United States
    39
    100%
    24
    100%
    63
    100%

    Outcome Measures

    1. Primary Outcome
    Title In-hospital Postoperative Opioid Consumption
    Description Daily overall opioid use recorded as morphine equivalents
    Time Frame up to postoperative day 3 at 1 pm

    Outcome Measure Data

    Analysis Population Description
    The amount of in-hospital postoperative opioid consumption was going to be obtained from the charts, where it is recorded as standard of care. However, this study was terminated prematurely before data could be collected from the charts; therefore no data are available for this outcome measure.
    Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
    Arm/Group Description Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine: Abdominal injection of bupivacaine into fascial layer. Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.
    Measure Participants 0 0
    2. Secondary Outcome
    Title Pain Score
    Description Recorded on a scale of 0 (No pain) to 10 (Worst possible pain)
    Time Frame Approximately every 6 hours through postoperative day 3 by 1 pm

    Outcome Measure Data

    Analysis Population Description
    Outcome data reported for patients with non-missing data. Pain scores presented are the first postoperative pain score per subject only due to missing data.
    Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
    Arm/Group Description Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine: Abdominal injection of bupivacaine into fascial layer. Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.
    Measure Participants 37 21
    Median (Inter-Quartile Range) [units on a scale]
    3
    3
    3. Secondary Outcome
    Title Time to Patient Mobilization
    Description Number of days from day of surgery until patient mobilization
    Time Frame From time of surgery until time of first patient ambulation post op. Assessed until date of discharge (usually up to 4 days after surgery).

    Outcome Measure Data

    Analysis Population Description
    Outcome data reported for subjects with non-missing data.
    Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
    Arm/Group Description Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine: Abdominal injection of bupivacaine into fascial layer. Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.
    Measure Participants 29 18
    Median (Inter-Quartile Range) [days]
    1
    0.5
    4. Secondary Outcome
    Title Time to Return of Bowel Function
    Description Number of days from time of surgery until return of bowel function
    Time Frame From time of surgery until first time patient passes gas or stool per rectum or into ostomy bag. Assessed until date of discharge (usually up to 4 days after surgery).

    Outcome Measure Data

    Analysis Population Description
    Outcome data reported for subjects with non-missing data.
    Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
    Arm/Group Description Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine: Abdominal injection of bupivacaine into fascial layer. Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.
    Measure Participants 28 18
    Median (Inter-Quartile Range) [days]
    2
    2
    5. Secondary Outcome
    Title Time to Clear Liquid Diet
    Description Number of days from time of surgery until patient tolerates clear liquid diet
    Time Frame From time of surgery until first time patient tolerates clear liquids without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).

    Outcome Measure Data

    Analysis Population Description
    Outcome data reported for subjects with non-missing data.
    Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
    Arm/Group Description Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine: Abdominal injection of bupivacaine into fascial layer. Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.
    Measure Participants 29 18
    Median (Inter-Quartile Range) [days]
    0
    0
    6. Secondary Outcome
    Title Time to Low Fiber Diet
    Description Number of days from day of surgery until patient tolerates low fiber diet
    Time Frame From time of surgery until first time patient tolerates a low fiber diet without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).

    Outcome Measure Data

    Analysis Population Description
    Outcome data reported for subjects with non-missing data.
    Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
    Arm/Group Description Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine: Abdominal injection of bupivacaine into fascial layer. Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.
    Measure Participants 28 17
    Median (Inter-Quartile Range) [days]
    1.5
    1
    7. Secondary Outcome
    Title Length of Stay
    Description Total postoperative hospital stay in days
    Time Frame Date of surgery to date of discharge (usually up to 4 days after surgery).

    Outcome Measure Data

    Analysis Population Description
    Outcome data reported for subjects with non-missing data.
    Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
    Arm/Group Description Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine: Abdominal injection of bupivacaine into fascial layer. Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.
    Measure Participants 31 18
    Median (Inter-Quartile Range) [days]
    3
    3.5
    8. Secondary Outcome
    Title In-hospital Antiemetic Use
    Description Amount of ondansetron patient required postoperatively during hospital stay, in milligrams
    Time Frame Time of transfer to post operative suite to time of discharge (usually up to 4 days after surgery).

    Outcome Measure Data

    Analysis Population Description
    Outcome data reported for subjects with non-missing data.
    Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
    Arm/Group Description Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine: Abdominal injection of bupivacaine into fascial layer. Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.
    Measure Participants 31 17
    Mean (Standard Deviation) [mg]
    2.9
    (3.6)
    5.6
    (12.5)
    9. Secondary Outcome
    Title Complications
    Description Patient suffered a complication (infection, small bowel obstruction, dehydration, deep vein thrombosis/pulmonary embolism, anastomotic leak, cardiac arrest, stroke, sepsis) after surgery
    Time Frame Within 30 days of surgery

    Outcome Measure Data

    Analysis Population Description
    Complications data was going to be collected from chart review. However, the study was prematurely terminated before this data could be collected.
    Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
    Arm/Group Description Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine: Abdominal injection of bupivacaine into fascial layer. Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.
    Measure Participants 0 0
    10. Secondary Outcome
    Title Readmissions
    Description Patient readmitted to hospital after discharge
    Time Frame Within 30 days of hospital discharge

    Outcome Measure Data

    Analysis Population Description
    Readmissions data was going to be collected from chart review. However, the study was prematurely terminated before this data could be collected.
    Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
    Arm/Group Description Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine: Abdominal injection of bupivacaine into fascial layer. Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.
    Measure Participants 0 0
    11. Secondary Outcome
    Title Mortality
    Description Patient death after surgery
    Time Frame Within 30 days of surgery

    Outcome Measure Data

    Analysis Population Description
    Mortality data was going to be collected from chart review. However, the study was prematurely terminated before this data could be collected.
    Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
    Arm/Group Description Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine: Abdominal injection of bupivacaine into fascial layer. Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.
    Measure Participants 0 0
    12. Secondary Outcome
    Title Hospitalization Costs
    Description Total hospitalization costs per patient per this surgical encounter
    Time Frame From date of this surgical admission to date of this surgical discharge (usually up to 4 days after surgery).

    Outcome Measure Data

    Analysis Population Description
    Cost data was intended to be collected through the finance department at the end of the study. However, the study was terminated prematurely, so cost data is not able to be obtained.
    Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
    Arm/Group Description Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine: Abdominal injection of bupivacaine into fascial layer. Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.
    Measure Participants 0 0

    Adverse Events

    Time Frame 30 days post-enrollment
    Adverse Event Reporting Description
    Arm/Group Title Standard Bupivacaine Bupivacaine Liposome
    Arm/Group Description Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine: Abdominal injection of bupivacaine into fascial layer. Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL. Bupivacaine liposome: Abdominal injection of bupivacaine liposome into fascial layer.
    All Cause Mortality
    Standard Bupivacaine Bupivacaine Liposome
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/39 (0%) 0/24 (0%)
    Serious Adverse Events
    Standard Bupivacaine Bupivacaine Liposome
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/39 (0%) 1/24 (4.2%)
    Surgical and medical procedures
    Hospitalization 0/39 (0%) 0 1/24 (4.2%) 1
    Other (Not Including Serious) Adverse Events
    Standard Bupivacaine Bupivacaine Liposome
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/39 (0%) 0/24 (0%)

    Limitations/Caveats

    Early termination due to lack of resources leading to incomplete data.

    More Information

    Certain Agreements

    Principal Investigators are NOT 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 Erica Emery
    Organization Inova Health System
    Phone 703-776-7615
    Email erica.emery@inova.org
    Responsible Party:
    Inova Health Care Services
    ClinicalTrials.gov Identifier:
    NCT03638635
    Other Study ID Numbers:
    • 17-2725
    First Posted:
    Aug 20, 2018
    Last Update Posted:
    Sep 9, 2019
    Last Verified:
    Apr 1, 2019