A Pain Study Comparing Two Commonly Used Medications to Treat Pain After Bowel Surgery
Study Details
Study Description
Brief Summary
This research study is testing whether the local anesthetic lidocaine is as effective as ropivacaine for post-operative pain control in continuous thoracic paravertebral nerve blocks. Ropivacaine and Lidocaine are FDA-approved drugs that has been successfully used in this hospital for post-operative pain control for the past few years, thus has become the standard drugs used for this nerve block. Lidocaine has numerous potential advantages over ropivacaine, such as faster onset of action, better safety profile and greater anti-inflammatory action. Catheters placed near both sides of a patient's spine for postoperative pain control are called thoracic paravertebral nerve blocks and are a part of routine care. Through those catheters, a "numbing" medication, or local anesthetic, to block the transmission of pain from the surgical incision to the spinal cord, thus reducing pain. The research part of the study is whether subjects will receive either the local anesthetic lidocaine or ropivacaine. The goal of this study is to determine whether the lidocaine controls pain better and facilitates a faster recovery after abdominal surgery than ropivacaine.
In this research study, the investigators will compare patient-reported pain scores, any additional pain medication requirements for adequate pain control, time it takes for bowel function to return to normal following surgery, as well as the incidence of any side effects, such as numbness and weakness, subjects may experience between those receiving lidocaine versus those receiving ropivacaine. The investigators will screen 100 patients and enroll 60 subjects into this study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
After determining eligibility, subjects will be enrolled in one of the two study groups on the day of surgery using a sealed envelope determined by a computer-generated list that made assignments randomly based on enrollment number. The study groups are defined as:
Study group: Lidocaine 0.25%(L) 32 patients Control group: Ropivacaine 0.2%(R) 32 patients
Paravertebral nerve block catheter placement and activation:
After standard monitors and supplemental oxygen are applied, the patient will be placed in a sitting position. The two points of needle entry will be marked on the skin corresponding to each of the bilateral paravertebral catheter placements. The thoracic spine level will be at the anatomic level corresponding to the midpoint of the incision as determined by the surgeon preoperatively (range T7 to T11). The needle entry sites will be 2.5 cm lateral on each side of the midpoint of the spinous process of the corresponding thoracic vertebrae. The area will be prepared and draped in a sterile fashion, and 1% lidocaine infiltrated subcutaneously at each point of anticipated needle entry. For each of the two catheter placements, a sterile 18 gauge Tuohy needle (B. Braun Medical, Inc., Perifix Continuous Epidural Anesthesia Set, Product Code CE18T) will be introduced perpendicularly to the skin until the transverse process is encountered, and the depth to the skin will be noted. The needle will then be readjusted in a caudad direction and inserted inferior to the corresponding transverse process to a depth approximately 1 cm deep to the transverse process. After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. Next 5 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through each catheter yielding a total activation dose of 15 ml of 0.5% Ropivacaine on each side. The catheters will be secured with Steri-strips and a transparent occlusive dressing. Vital signs will be monitored by the nurse at regular intervals until the patient is taken to the operating room.
Postoperative Management:
Post Anesthesia Care Unit (PACU):
Following routine intraoperative general anesthesia care, management in the post-anesthesia care unit will follow the standard of care for colorectal surgery. Bilateral paravertebral infusions of ropivacaine 0.2% or lidocaine 0.25% will be started at 7 mL/hr on each side for the patients depending which to group they were randomized. The patients in both groups will also be given access to PCA dilaudid (0.2 mg bolus, 8 min lockout, no basal infusion, no 1-hour limit) once verbal pain score is ≤4. Additional pain relief is available via nurse-administered 10 mL/hour boluses of ropivacaine 0.2% or lidocaine 0.25% via the catheter pumps (5 mL each side for paravertebral group).This will be continued until the patient is able to tolerate oral pain medication. A single IV bolus of ketorolac at 7.5 mg will be available for additional pain management. Patient reported pain scores and total analgesic requirements will be recorded. Once adequate analgesia is established without any signs of adverse effects from the nerve blocks, the patients will be transferred to a hospital floor bed.
Floors:
After discharge from the PACU, additional pain relief is available via nurse-administered 3 mL boluses of local anesthetic via the catheter pumps (3 mL each side for paravertebral group) given no more than hourly. In addition, nurse-administered intravenous boluses of dilaudid 0.3 mg every 30 minutes as needed up to 2 doses while the patient has PCA, and 0.8-1 mg every hour as needed up to 4 doses in 2 hours once the patient is taking oral pain therapy and is off the PCA. All patients will be assessed daily by members of the acute interventional perioperative pain service. Also, a member of the acute pain service will be on-call 24 hours if inadequate pain control or side effects arise. The infusion rates via the paravertebral catheters may be adjusted at the discretion of the pain service up to a rate of 10 mL/hr of either lidocaine 0.25% or ropivacaine 0.2% on each side (standard infusion rate used at UPMC). The PCA dose may be adjusted as deemed necessary by the acute pain team in order provide adequate analgesia. In addition 7.5mg IV of ketorolac may be administered every 6 hours for the first 48 hours. Once the patient is able to tolerate oral liquids as determined by the surgeon, the PCA will be discontinued and oxycodone 5 mg available to the patient every 4 hours as needed for mild-moderate pain or oxycodone 10 mg every 6 hours as needed for severe pain. These doses may be adjusted as necessary by the pain service. All paravertebral catheters will be stopped and removed on the day after the patient has his/her first bowel movement or post-operative day #4, whichever occurs first. Pain scores collected by the nurses and supplemental analgesic requirements will be the data points for this study. Also, return of flatus and first bowel movement as documented in the AIPPS and surgery team's daily round notes will be recorded during the length of the hospitalization respectively.
For each patient, the investigators collected numerical rating scores (NRS) for pain at rest and during movement at baseline, at postanesthesia care unit discharge, at 24 hours and 48 hours after the end of surgery,
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Lidocaine Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. |
Drug: Lidocaine
Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.
At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.
Other Names:
|
| Active Comparator: Ropivacaine Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years. |
Drug: Ropivacaine
0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 11-point Verbal Numerical Rating Scale (NRS) Pain Assessment [24 hours from the end of surgery]
The primary outcome of the study is the NRS score for pain at rest at 24 hours. The NRS Pain Assessment requires patients to select a number between 0 - 10 where 0 is no pain and 10 is the worst imaginable pain. Patients pick one whole number on this scale to describe their pain.
Secondary Outcome Measures
- Time to First Ambulation(Walking Greater Than 15 Feet) [During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)]
During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.
- Time to First Flatus/Defecation [During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)]
During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.
- Hospital Length of Stay. [During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)]
During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.
- Number of Patients With Complications (Including But Not Limited to Pneumonia, Atelectasis, Hypotension, Motor Weakness, Etc.) [During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)]
During the hospitalization following surgery until discharge.
- Postoperative Opioid Consumption (Milligrams of Dilaudid or Equivalent) [During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)]
During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.
- Consumption of Nerve Block Boluses Will Also be Recorded Daily [During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)]
During the hospitalization following surgery until discontinuation of the block or discharge. Hospital length of stay ranged from 3 - 22 days following surgery.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
ASA I-III subjects
-
Ages 18-80 years
-
Weight between 60 and 110 Kg
-
At least 60in (152cm) tall
-
Scheduled for elective open colonic surgery at UPMC Presbyterian Shadyside Hospital in Pittsburgh, Pennsylvania
Exclusion Criteria:
-
Age younger than 18 years or older than 80 years
-
Any contraindication to the placement of bilateral thoracic paravertebral catheters
-
American Society of Anesthesiologists physical status IV or greater
-
Chronic painful conditions
-
Preoperative opioid use
-
Coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively
-
Allergy to any of the drugs/agents used study protocol
-
Personal or family history of malignant hyperthermia
-
Serum creatinine greater than 1.3 g/dl
-
Pregnancy
-
Having an altered mental status (not oriented to place, person, or time)
-
Emergency surgery and those with sepsis, unstable angina, congestive heart disease, valvular heart disease, and severe COPD
-
Patient's inability to provide adequate informed consent
-
Non-english speaking
-
Patient refusal
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UPMC Presbyterian Shadyside | Pittsburgh | Pennsylvania | United States | 15232 |
Sponsors and Collaborators
- Jacques E. Chelly
- University of Pittsburgh
Investigators
- Principal Investigator: Andrea Fanelli, MD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO07080230
Study Results
Participant Flow
| Recruitment Details | Patients were enrolled between the period of October, 2009 and August, 2011 |
|---|---|
| Pre-assignment Detail | Three patients were consented but not randomized due to failure to meet inclusion criteria (3 screen failures) |
| Arm/Group Title | Lidocaine | Ropivacaine |
|---|---|---|
| Arm/Group Description | Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. | Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years. Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. |
| Period Title: Overall Study | ||
| STARTED | 20 | 24 |
| COMPLETED | 17 | 18 |
| NOT COMPLETED | 3 | 6 |
Baseline Characteristics
| Arm/Group Title | Lidocaine | Ropivacaine | Total |
|---|---|---|---|
| Arm/Group Description | Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. | Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years. Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. | Total of all reporting groups |
| Overall Participants | 17 | 18 | 35 |
| Age, Customized (participants) [Number] | |||
| Age over 18 years |
17
100%
|
18
100%
|
35
100%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
9
52.9%
|
2
11.1%
|
11
31.4%
|
| Male |
8
47.1%
|
16
88.9%
|
24
68.6%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
17
100%
|
18
100%
|
35
100%
|
Outcome Measures
| Title | 11-point Verbal Numerical Rating Scale (NRS) Pain Assessment |
|---|---|
| Description | The primary outcome of the study is the NRS score for pain at rest at 24 hours. The NRS Pain Assessment requires patients to select a number between 0 - 10 where 0 is no pain and 10 is the worst imaginable pain. Patients pick one whole number on this scale to describe their pain. |
| Time Frame | 24 hours from the end of surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients undergoing elective laparoscopic bowel surgery with bilateral thoracic paravertebral continuous nerve blocks. |
| Arm/Group Title | Lidocaine | Ropivacaine |
|---|---|---|
| Arm/Group Description | Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. | Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years. Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. |
| Measure Participants | 17 | 18 |
| Median (Full Range) [Scores on a scale] |
3
|
3
|
| Title | Time to First Ambulation(Walking Greater Than 15 Feet) |
|---|---|
| Description | During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery. |
| Time Frame | During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 6 participants assigned to Group Ropi, 3 to Group Lido were not included in this analysis for the following reasons: 1 required mechanical ventilation post-op, 1 was excluded due to changes in surgical procedure, 2 patients did not complete PCA regimen, technical issues with block excluded 5 patients from analysis (considered protocol violations). |
| Arm/Group Title | Lidocaine | Ropivacaine |
|---|---|---|
| Arm/Group Description | Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. | Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years. Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. |
| Measure Participants | 17 | 18 |
| Median (Full Range) [days] |
2
|
1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine, Ropivacaine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups. | |
| Statistical Test of Hypothesis | p-Value | 0.148 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Time to First Flatus/Defecation |
|---|---|
| Description | During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery. |
| Time Frame | During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lidocaine | Ropivacaine |
|---|---|---|
| Arm/Group Description | Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. | Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years. Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. |
| Measure Participants | 17 | 18 |
| Median (Full Range) [Postoperative days] |
2
|
2
|
| Title | Hospital Length of Stay. |
|---|---|
| Description | During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery. |
| Time Frame | During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 6 participants assigned to Group Lopi, 3 to Group Lido were not included in this analysis for the following reasons: 1 required mechanical ventilation post-op, 1 was excluded due to changes in surgical procedure, 2 patients did not complete PCA regimen, and technical issues with block excluded 5 patients from analysis. |
| Arm/Group Title | Lidocaine | Ropivacaine |
|---|---|---|
| Arm/Group Description | Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. | Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years. Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. |
| Measure Participants | 17 | 18 |
| Median (Full Range) [days] |
5
|
5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine, Ropivacaine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups. | |
| Statistical Test of Hypothesis | p-Value | .636 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Number of Patients With Complications (Including But Not Limited to Pneumonia, Atelectasis, Hypotension, Motor Weakness, Etc.) |
|---|---|
| Description | During the hospitalization following surgery until discharge. |
| Time Frame | During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lidocaine | Ropivacaine |
|---|---|---|
| Arm/Group Description | Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. | Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years. Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. |
| Measure Participants | 17 | 18 |
| Hypotension (Patient 19) |
1
5.9%
|
0
0%
|
| Deydration with Acute Renal Failure (Patient 7) |
1
5.9%
|
0
0%
|
| Small Bowel Obstruction (Patients 43, 24, 34) |
1
5.9%
|
2
11.1%
|
| Rectal Bleeding (Patient 23) |
0
0%
|
1
5.6%
|
| Anastamotic Dehiscence with Pelvic Abscess -Pt. 34 |
0
0%
|
1
5.6%
|
| Tremors After Anesthetic Boli (Patient 34) |
0
0%
|
1
5.6%
|
| Title | Postoperative Opioid Consumption (Milligrams of Dilaudid or Equivalent) |
|---|---|
| Description | During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery. |
| Time Frame | During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 6 participants assigned to Group Ropi, 3 to Group Lido were not included in this analysis for the following reasons: 1 required mechanical ventilation post-op, 1 was excluded due to changes in surgical procedure, 2 patients did not complete PCA regimen, and technical issues with block excluded 5 patients from analysis. |
| Arm/Group Title | Lidocaine | Ropivacaine |
|---|---|---|
| Arm/Group Description | Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. | Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years. Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. |
| Measure Participants | 17 | 18 |
| Hydromorphone PACU |
1.6
|
1.1
|
| Hydromorphone 24HRS |
9.2
|
5.7
|
| Hydromorphone 48HRS |
16.1
|
9.6
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine, Ropivacaine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups. | |
| Statistical Test of Hypothesis | p-Value | 0.193 |
| Comments | Hydromorphone consumption (mg) in Post-Anesthesia Care Unit (PACU) | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine, Ropivacaine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups. | |
| Statistical Test of Hypothesis | p-Value | 0.635 |
| Comments | Hydromorphone consumption (mg) in PACU versus at 24 hours versus 48 hours | |
| Method | ANOVA | |
| Comments | ||
| Title | Consumption of Nerve Block Boluses Will Also be Recorded Daily |
|---|---|
| Description | During the hospitalization following surgery until discontinuation of the block or discharge. Hospital length of stay ranged from 3 - 22 days following surgery. |
| Time Frame | During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 6 participants assigned to Group Lopi, 3 to Group Lido were not included in this analysis for the following reasons: 1 required mechanical ventilation post-op, 1 was excluded due to changes in surgical procedure, 2 patients did not complete PCA regimen, and technical issues with block excluded 5 patients from analysis. |
| Arm/Group Title | Lidocaine | Ropivacaine |
|---|---|---|
| Arm/Group Description | Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. | Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years. Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. |
| Measure Participants | 17 | 18 |
| Nerve block boluses PACU |
20
|
20
|
| Nerve block boluses 24HRS |
0
|
0
|
| Nerve block boluses 48HRS |
0
|
0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Lidocaine, Ropivacaine |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups. | |
| Statistical Test of Hypothesis | p-Value | 0.063 |
| Comments | ||
| Method | ANOVA | |
| Comments | Local Anesthetic Consumption through para-vertebral catheters in PACU vs. at 24 hours vs. 48 hours | |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Lidocaine | Ropivacaine | ||
| Arm/Group Description | Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use. | Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years. Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. | ||
All Cause Mortality |
||||
| Lidocaine | Ropivacaine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Lidocaine | Ropivacaine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/17 (0%) | 0/18 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Lidocaine | Ropivacaine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/17 (5.9%) | 4/18 (22.2%) | ||
| Surgical and medical procedures | ||||
| Surgical Complications | 1/17 (5.9%) | 1 | 4/18 (22.2%) | 4 |
Limitations/Caveats
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 | Jacques E. Chelly, MD, PhD, MBA |
|---|---|
| Organization | University of Pittsburgh Medical Center Department of Anesthesiology |
| Phone | 412-623-6382 |
| chelje@anes.upmc.edu |
- PRO07080230