Liposomal Bupivacaine in Bariatric Surgery

Randomized Controlled Trial Investigating Use of Liposomal Bupivacaine in Bariatric Surgery

The aim of this study is to perform a randomized controlled trial for patients undergoing bariatric surgery, comparing the need for opiates with and without administration of a transversus abdominis plane (TAP) block using the long acting local anesthetic, liposomal bupivacaine (Exparel®). From this study, the investigators will assess whether use of long acting local anesthetic can reduce the need for opiates in the bariatric population.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Analgesia
• Intervention / Treatment: Drug: Liposomal Bupivacaine TAP block; Drug: Bupivacaine TAP block

Detailed Description

A prospective randomized controlled trial investigating the use of long acting local anesthetic for transversus abdominis block in patients undergoing bariatric surgery at Montefiore Medical Center. Patients will be randomized to either receive an intraoperative TAP block with LB, an intraoperative TAP block with RB, or no TAP block. All participants will receive standard post-operative analgesia regimen. Pain scores will be recorded by the nursing staff as reported by the patients for 24-36 hours post surgery. Patients will be monitored for secondary post-operative complications up to the 2-week mark following intervention.

• Study Type: Interventional
• Enrollment (Actual): 219
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Obese patients undergoing bariatric surgery (LSG or LRYGB)
• Patients 18 years of age and older
• Surgical treatment between 01/01/2018 and 12/31/2018 over a 1 year period

Exclusion Criteria:

• Patients under the age of 18 years old
• Patients taking any opiates within 30 days of enrollment in the trial
• Patients with a history of chronic pain.
• Patients taking pregabalin or gabapentin.
• ASA IV
• Prior laparotomy
• Body Mass Index ≥ 60 kg/m2
• History of cardiac arrhythmia
• History of Seizure
• Psychiatric Diagnosis currently on antipsychotic medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liposomal Bupivacaine TAP block; Patients will be randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with liposomal bupivacaine (LB). The solution used to perform the TAP block with LB will comprise of 20mL of liposomal bupivacaine solution, 30mL of 0.25% bupivacaine, and 100mL of normal saline.	Drug: Liposomal Bupivacaine TAP block; Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.; Other Names: Exparel TAP block
Active Comparator: Regular Bupivacaine TAP block; Patients will be randomized to receive an intraoperative transverse abdominis peritoneal (TAP) block with regular bupivacaine (RB).The solution used to perform the TAP block with RB will comprise of 50mL of 0.25% bupivacaine and 100mL of normal saline.	Drug: Bupivacaine TAP block; Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
No Intervention: No TAP block; Patients will be randomized to receive no TAP block as a control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fentanyl PCA mcg	Fentanyl PCA (patient controlled analgesia) total microgram usage.	24 hours post surgery.
Total Fentanyl Usage	Total fentanyl usage in micrograms, including both PCA and IV push administered medication.	During hospitalization, up to 7 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acetaminophen Usage	Total amount of acetaminophen used for analgesia.	During hospitalization, up t 7 days.
NSAID Usage	Total amount of NSAID (ketorolac) use for analgesia.	During hospitalization, up to 7 days.
Pain Score	Patient reported composite measure pain score, with a total range of 0 to 10, with 0 being the absence of pain, 1 being the least amount of pain and 10 being the highest amount of pain.	24 hours post surgery.
Length of Stay	Hours of hospitalization post-surgery	Assessed every 24 hours post surgery, up to 168 hour post-surgery.
Nausea	Number of participants with presence or absence of nausea reported and recorded by the nurse.	24 hours post surgery.
Time to Ambulation		Assessed every 24 hours post surgery, up to 168 hour post-surgery.

Collaborators and Investigators

• Sponsor: Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: December 9, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: bariatric surgery; liposomal bupivacaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2017-7706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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