Phase 4
N=126
Bupivacaine Liposomal Injection (Exparel) for Postsurgical Analgesia in Patient Undergoing Laparoscopic Bariatric Surgery
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT02969187 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Total Amount of Opioids at 48 Hours — 29.5; 27.1 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Exparel (Drug); Bupivacain (Drug); Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Amount of Opioids at 48 Hours |
29.5; 27.1 | — |
| SECONDARY Cumulative Pain Score Through 48 Hours After Surgery |
177.0; 167.8 | — |
| SECONDARY Cumulative Nausea Score |
79; 98 | — |
Summary
Despite the increasing use of patient-controlled anesthesia (PCA) for postoperative pain management, efforts are continuing to find effective methods to relieve pain after abdominal surgery. Although opioid is an effective analgesic it has opioid related adverse events (ORAEs). Bupivacaine should reduce postoperative pain but it has relatively shorter duration of action. Liposome bupivacaine (Exparel) has been approved as a single dose infiltration for longer postoperative period analgesic. It provides up to 72 hours analgesia postoperatively; results in lesser opioids usage and reduce the ORAEs. Transversus abdominis plane (TAP) block is a relatively new regional anesthetic technique. TAP blocks have been performed to reduce opioid use and control pain in several laparoscopic surgical procedures, including colorectal resections, cholecystectomy and bariatric surgery. The aim of this study is to study the opiate usage, pain and nausea post laparoscopic gastric bypass or sleeve gastrectomy using Exparel versus Bupivacaine as TAP block and port sites infiltration.
Eligibility Criteria
Inclusion Criteria
- Fulfills NIH criteria for bariatric surgery
- Planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure
Exclusion Criteria
- BMI 60 kg/m2
- Inability to walk (bed-bound or wheelchair dependence)
- Previous major abdominal surgery (possible adhesions and longer operation) defined as:
- open abdominal surgeries except simple appendectomy and common OB/GYN procedures in the pelvis (hysterectomy, C-section, and oophorectomy, tubal ligation)
- laparoscopic bowel or solid organ resection except laparoscopic cholecystectomy
- ventral hernia repair with mesh
- Preoperative chronic opiate use for chronic pain defined as opiate usage at least 60 mg/day of morphine equivalent for ≥ 3 months (as defined by International Association for the Study of Pain22) in the one year period prior to the bariatric surgery
- The American Society of Anesthesiologists (ASA) score > 3
- History of hypersensitivity or adverse reaction to bupivacaine or narcotics
- Inability to speak English
- Concurrent surgical procedure including:
- ventral hernia repair
- Cholecystectomy
- hiatal hernia repair with posterior cruroplasty
- extensive lysis of adhesions
- other procedures that mandate addition of "trocar(s)" or "feeding tube"
- Addition of trocar(s) or conversion of surgery to hand-assisted or open
Data sourced from ClinicalTrials.gov (NCT02969187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.