Liposomal Bupivacaine in Bariatric Surgery

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 2

Conditions: Bariatric Surgery Analgesia

Treatments: Drug: Bupivacaine TAP block; Drug: Liposomal Bupivacaine TAP block

Study type: Interventional

Funder types: Other

Identifiers

NCT03373591

2017-7706

Details and patient eligibility

About

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.

Full 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.

Enrollment: 219 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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219 participants in 3 patient groups

Liposomal Bupivacaine TAP block

Experimental group

Description:

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.

Treatment:

Drug: Liposomal Bupivacaine TAP block

Regular Bupivacaine TAP block

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine TAP block

No TAP block

No Intervention group

Description:

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