Liposomal Bupivacaine in Bariatric Surgery

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-30

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bariatric Surgery Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Liposomal Bupivacaine TAP block

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine TAP block

Intervention Type DRUG

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

No TAP block

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Liposomal Bupivacaine TAP block

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

Intervention Type DRUG

Bupivacaine TAP block

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

Intervention Type DRUG

Other Intervention Names

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Exparel TAP block

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Diego Camacho

Director Minimally Invasive and Endoscopic Surgery, Fellowship Program Director, Associate Professor of Surgery Albert Einstein College of Medicine, Montefiore Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR