Bupivacaine Liposomal Injection (Exparel) for Postsurgical Analgesia in Patient Undergoing Laparoscopic Bariatric Surgery

NCT02969187 | Completed Phase 4 Results

• 1 other identifier: 15-1318
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Total Amount of Opioids at 48 Hours

  The total amount of opioids used will be recorded from the nurse chart.

  At 48 hours post operative

Secondary Outcomes (2)

• Cumulative Pain Score Through 48 Hours After Surgery

  Pain assessed when the patient is admitted to the recovery room after surgery, every 8 hrs thereafter for up to 48 hours post operatively

• Cumulative Nausea Score

  Nausea assessed when the patient is admitted to the recovery room after surgery, every 8 hrs thereafter for up to 72 hours post operatively

Study Arms (2)

Experimental

EXPERIMENTAL

Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 20 ml of 1.3% Exparel + 30 ml of 0.5% Bupivacaine + 150 ml of Saline

Drug: Exparel; Drug: Bupivacain; Drug: Saline

Control

ACTIVE COMPARATOR

Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 60ml of 0.5% Bupivacaine + 140 ml of Saline.

Drug: Bupivacain; Drug: Saline

Interventions

Exparel DRUG

6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Exparel will be injected at port sites.

Experimental

Bupivacain DRUG

6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites.

Control; Experimental

Saline DRUG

Control; Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• BMI \<35 and \> 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

There is no data available to guide us on the dosage of liposome bupivacaine in bariatric surgery. We assume adequate quantity and coverage of liposome bupivacaine (266mg) in this obese population, despite that they have a bigger surface area.

Results Point of Contact

• Title: Dr. Philip R. Schauer
• Organization: Cleveland Clinic

schauep@ccf.org

216-444-4794

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Surgeon

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 21, 2016
• Study Start: November 1, 2016
• Primary Completion: January 31, 2018
• Study Completion: March 31, 2018
• Last Updated: March 3, 2020
• Results First Posted: March 3, 2020

Record last verified: 2020-02

Locations

US (1)