Liposomal Bupivacaine in Bariatric Surgery
- Conditions
- Bariatric Surgery Analgesia
- Interventions
- Drug: Liposomal Bupivacaine TAP block
- Registration Number
- NCT03373591
- Lead Sponsor
- Montefiore Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 219
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liposomal Bupivacaine TAP block 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. Regular Bupivacaine TAP block 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.
- Primary Outcome Measures
Name Time Method Fentanyl PCA mcg 24 hours post surgery. Fentanyl PCA (patient controlled analgesia) total microgram usage.
Total Fentanyl Usage During hospitalization, up to 7 days. Total fentanyl usage in micrograms, including both PCA and IV push administered medication.
- Secondary Outcome Measures
Name Time Method Acetaminophen Usage During hospitalization, up t 7 days. Total amount of acetaminophen used for analgesia.
NSAID Usage During hospitalization, up to 7 days. Total amount of NSAID (ketorolac) use for analgesia.
Pain Score 24 hours post surgery. 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.
Length of Stay Assessed every 24 hours post surgery, up to 168 hour post-surgery. Hours of hospitalization post-surgery
Nausea 24 hours post surgery. Number of participants with presence or absence of nausea reported and recorded by the nurse.
Time to Ambulation Assessed every 24 hours post surgery, up to 168 hour post-surgery.
Trial Locations
- Locations (1)
Montefiore Medical Center
🇺🇸Bronx, New York, United States