Randomized Controlled Trial Investigating Use of Liposomal Bupivacaine in Bariatric Surgery
Overview
- Phase
- Phase 2
- Intervention
- Liposomal Bupivacaine TAP block
- Conditions
- Bariatric Surgery Analgesia
- Sponsor
- Montefiore Medical Center
- Enrollment
- 219
- Locations
- 1
- Primary Endpoint
- Fentanyl PCA mcg
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
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.
Investigators
Diego Camacho
Director Minimally Invasive and Endoscopic Surgery, Fellowship Program Director, Associate Professor of Surgery Albert Einstein College of Medicine, Montefiore Medical Center
Montefiore Medical Center
Eligibility Criteria
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.
- •Prior laparotomy
- •Body Mass Index ≥ 60 kg/m2
- •History of cardiac arrhythmia
- •History of Seizure
- •Psychiatric Diagnosis currently on antipsychotic medication
Arms & Interventions
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.
Intervention: Liposomal Bupivacaine TAP block
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.
Intervention: Bupivacaine TAP block
Outcomes
Primary Outcomes
Fentanyl PCA mcg
Time Frame: 24 hours post surgery.
Fentanyl PCA (patient controlled analgesia) total microgram usage.
Total Fentanyl Usage
Time Frame: During hospitalization, up to 7 days.
Total fentanyl usage in micrograms, including both PCA and IV push administered medication.
Secondary Outcomes
- Length of Stay(Assessed every 24 hours post surgery, up to 168 hour post-surgery.)
- Acetaminophen Usage(During hospitalization, up t 7 days.)
- NSAID Usage(During hospitalization, up to 7 days.)
- Pain Score(24 hours post surgery.)
- Nausea(24 hours post surgery.)
- Time to Ambulation(Assessed every 24 hours post surgery, up to 168 hour post-surgery.)