Evaluation of Aerosolized Bupivacaine Versus Pre-incision Lidocaine Versus Instilled Liquid Bupivacaine Versus Post-operative Bupivacaine Injection for Optimization of Post-operative Pain Control in Laparoscopic Bariatric Surgical Patients
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Measure of reduction in post-operative pain and narcotics usage.
Study Overview
Brief Summary
The purpose of this study is to determine if pre-incisional lidocaine injection, instilled liquid bupivacaine, intra-abdominal aerosolized bupivacaine, or post-operative bupivacaine injection is superior in post-operative pain control in laparoscopic bariatric surgical patients.
Detailed Description
The research objective is to compare our standard post-operative port site injection of 0.5% bupivacaine against pre-incisional port site injection of 1% lidocaine against the instillation of streamed bupivacaine 0.5% against the instillation of aerosolized 0.5% bupivacaine as it relates to post-operative analgesia usage and pain scale scores. The null hypothesis will be that there is no difference between the four arms of the study in regards to pain score and analgesia usage.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male and female patients between 18 and 65 years of age.
- •Patients undergoing elective bariatric surgery.
Exclusion Criteria
- •Patients allergic to bupivacaine or any other local anesthetics (amides & esters).
- •Patients who have used opiates or opiods within 15 days prior to surgery.
- •Patients converted to open gastric bypass.
Arms & Interventions
3
Intervention: Streamed bupivacaine versus streamed normal saline (Drug)
2
Intervention: Injected lidocaine pre-incision vs saline pre-incision (Drug)
4
Intervention: Aerosolized bupivacaine versus aerosolized saline (Drug)
1
Intervention: Injected bupivacaine post-operatively (Drug)
Outcomes
Primary Outcomes
Measure of reduction in post-operative pain and narcotics usage.
Time Frame: First 3 days post-operatively.
Secondary Outcomes
No secondary outcomes reported
Investigators
Troy Moritz, D.O.
Troy Moritz DO
Pinnacle Health System