Liposomal Bupivacaine in Bariatric Surgery

Study Overview
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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.

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.

Official Title
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Randomized Controlled Trial Investigating Use of Liposomal Bupivacaine in Bariatric Surgery

Conditions
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Bariatric Surgery Analgesia

Intervention / Treatment
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* Drug: Liposomal Bupivacaine TAP block
* Drug: Bupivacaine TAP block


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal Bupivacaine TAP block<br>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<br>* Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.<br>* Other names: Exparel TAP block;|
| Active Comparator: Regular Bupivacaine TAP block<br>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<br>* Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.<br>|
| No Intervention: No TAP block<br>Patients will be randomized to receive no TAP block as a control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acetaminophen Usage | Total amount of acetaminophen used for analgesia. | During hospitalization, up t 7 days. | 
| NSAID Usage | Total amount of NSAID (ketorolac) use for analgesia. | During hospitalization, up to 7 days. | 
| Pain Score | 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. | 24 hours post surgery. | 
| Length of Stay | Hours of hospitalization post-surgery | Assessed every 24 hours post surgery, up to 168 hour post-surgery. | 
| Nausea | Number of participants with presence or absence of nausea reported and recorded by the nurse. | 24 hours post surgery. | 
| Time to Ambulation |  | Assessed every 24 hours post surgery, up to 168 hour post-surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, liposomal bupivacaine