Liposomal Bupivacaine in Bariatric Surgery

NCT03373591 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2017-7706
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bariatric Surgery Analgesia

Keywords

bariatric surgery; liposomal bupivacaine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Acetaminophen Usage

  During hospitalization, up t 7 days.

• NSAID Usage

  During hospitalization, up to 7 days.

• Pain Score

  24 hours post surgery.

• Length of Stay

  Assessed every 24 hours post surgery, up to 168 hour post-surgery.

• Nausea

  24 hours post surgery.

Study Arms (3)

Liposomal Bupivacaine TAP block

EXPERIMENTAL

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

Regular Bupivacaine TAP block

ACTIVE COMPARATOR

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

No TAP block

NO INTERVENTION

Patients will be randomized to receive no TAP block as a control group.

Interventions

Liposomal Bupivacaine TAP block DRUG

Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.

Also known as: Exparel TAP block

Liposomal Bupivacaine TAP block

Bupivacaine TAP block DRUG

Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.

Regular Bupivacaine TAP block

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Limitations and Caveats

Further studies are needed to attempt to match patients based on variables that effect opiate metabolism and pain response, and to include alternative secondary outcomes.

Results Point of Contact

• Title: Diego Camacho, MD
• Organization: Montefiore Medical Center

dicamach@montefiore.org

718-920-4800

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Minimally Invasive and Endoscopic Surgery, Fellowship Program Director, Associate Professor of Surgery Albert Einstein College of Medicine, Montefiore Medical Center

Study Record Dates

• First Submitted: December 9, 2017
• First Posted: December 14, 2017
• Study Start: January 30, 2018
• Primary Completion: June 30, 2018
• Study Completion: December 31, 2018
• Last Updated: November 4, 2019
• Results First Posted: November 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)