Bariatric Surgery Candidate, Pain, Postoperative
Conditions
Keywords
Anesthetics, Local, Liposomal Bupivacaine, Bupivacaine, Postoperative Complications, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, Laparoscopic Bariatric Surgery
Brief summary
This study is prospective, randomized trial in which the efficacy of liposomal bupivacaine (Exparel®) is compared to standard bupivacaine local surgical site injection in reducing total IV and oral morphine equivalents required after laparoscopic bariatric surgery. Liposomal bupivacaine is a 72-hour bupivacaine that is slowly released from tissue over the course of three days. Having a long acting local anesthetic should provide better pain control than conventional bupivacaine which has a 3.5-hour half-life. In some studies, the use of liposomal bupivacaine has been shown to decrease pain and narcotic use after surgery. This has not yet been studied in bariatric patients and the use of liposomal bupivacaine can potentially improve patient post-operative pain control, decrease narcotic use, decrease hospital length of stay and readmission rates and improve patient satisfaction after bariatric surgery.
Interventions
Liposomal bupivacaine 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
DRUGBupivacaine
60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* All patients undergoing elective laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass surgeries. * Fulfills NIH criteria for bariatric surgery
Exclusion criteria
* Patients deemed not a candidate for laparoscopic bariatric surgery * Patients with previous bariatric or gastric surgeries. * BMI \<35 and \> 60 kg/m2 * Preoperative inability to ambulate and confined to wheelchair. * American Society of Anesthesiologist (ASA) score \>3 * Concurrent ventral hernia repair or intraoperative extensive lysis of adhesions * Not able to understand informed consent, or unwilling to sign consent. * Not able to understand and read English * Currently pregnant or lactating. * Age \<18 or \>65 * Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics. * Patients requiring opiate use within 30 days prior to time of surgery. * Patients with reported use of narcotics greater than 2 weeks in preceding year before surgery. * Patients with history of substance abuse, alcohol addiction * Patients with diagnosis of chronic pain, history of fibromyalgia, chronic regional pain syndrome (dystrophic pain syndrome). * Bupivacaine use within 96 hours before operation * Prisoners * Bariatric surgery operation \>3 hours. * More than 5 laparoscopic incision sites used during surgery, conversion to open operation, placement of a feeding tube or drain. * Patients with renal failure or hepatic failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Equivalents | within 1 week post-operatively | in hospital total oral and IV morphine equivalents required after laparoscopic bariatric surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Pain Score | within 48 hours post operatively | Average pain scores by blinded nurse obtained. Analogue pain rating scale ranged from 0 to 10 with 0 being no pain and 10 being the worst possible pain. Assessment of pain and nausea were performed every 4 hours after operation until discharge. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine Liposomal bupivacaine (Exparel) 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
Exparel 266 MG Per 20 ML Injection: Liposomal bupivacaine 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites). | 89 |
| Control 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
Bupivacaine: 60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites). | 90 |
| Total | 179 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 26 | 26 |
Baseline characteristics
| Characteristic | Liposomal Bupivacaine | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 89 Participants | 90 Participants | 179 Participants |
| Age, Continuous | 39.2 years STANDARD_DEVIATION 9.8 | 39.2 years STANDARD_DEVIATION 10.1 | 39.2 years STANDARD_DEVIATION 9.9 |
| Body Mass Index (BMI) | 45.4 Kg/m^2 STANDARD_DEVIATION 5.9 | 44.5 Kg/m^2 STANDARD_DEVIATION 5.5 | 45 Kg/m^2 STANDARD_DEVIATION 5.7 |
| Diabetes | 13 Participants | 13 Participants | 26 Participants |
| Hypertension | 35 Participants | 29 Participants | 64 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 68 Participants | 74 Participants | 142 Participants |
| Sex: Female, Male Male | 21 Participants | 16 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 89 | 0 / 90 |
| other Total, other adverse events | 0 / 89 | 0 / 90 |
| serious Total, serious adverse events | 5 / 89 | 3 / 90 |
Outcome results
Primary
Morphine Equivalents
in hospital total oral and IV morphine equivalents required after laparoscopic bariatric surgery.
Time frame: within 1 week post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine | Morphine Equivalents | 8.3 MEU | Standard Deviation 4 |
| Control | Morphine Equivalents | 7.5 MEU | Standard Deviation 3.6 |
Secondary
Cumulative Pain Score
Average pain scores by blinded nurse obtained. Analogue pain rating scale ranged from 0 to 10 with 0 being no pain and 10 being the worst possible pain. Assessment of pain and nausea were performed every 4 hours after operation until discharge.
Time frame: within 48 hours post operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine | Cumulative Pain Score | 3.5 score on a scale | Standard Deviation 1.7 |
| Control | Cumulative Pain Score | 3.6 score on a scale | Standard Deviation 1.9 |