Clinical Proposal for the Comparison of Intraperitoneal Anesthetic to Injected Local Anesthetic

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pain, Postoperative, Morbid Obesity

Intervention / Treatment
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* Drug: Injected bupivacaine post-operatively
* Drug: Streamed bupivacaine versus streamed normal saline
* Drug: Aerosolized bupivacaine versus aerosolized saline
* Drug: Injected lidocaine pre-incision vs saline pre-incision


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3<br> | Drug: Streamed bupivacaine versus streamed normal saline<br>* Patients will receive 30ml of 0.9% normal saline divided equally and injected prior to port site incisions, then 10ml of 0.5% bupivacaine streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.<br>* Other names: normal saline;|
| Experimental: 2<br> | Drug: Injected lidocaine pre-incision vs saline pre-incision<br>* Patients will receive 30ml of 1% lidocaine divided equally and injected prior to port site incisions, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.<br>* Other names: pre-emptive;|
| Experimental: 4<br> | Drug: Aerosolized bupivacaine versus aerosolized saline<br>* Patients will receive 30 ml of 0.9% normal saline divided equally and injected prior to port site incision, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.5% bupivacaine aerosolized into coelomic cavity prior to deflation and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.<br>* Other names: aerosolized;|
| Active Comparator: 1<br> | Drug: Injected bupivacaine post-operatively<br>* Patients will receive 30 ml of 0.9% normal saline divided equally and injected prior to port site incision, then 10ml of 0.9% normal saline streamed via port directed at operative field, then 10ml of 0.9% normal saline aerosolized into the coelomic cavity prior to deflation, and our current standard of care, which is 30ml of 0.5% bupivacaine, divided equally between the five port-sites, injected at the end of the operation.<br>* Other names: bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of reduction in post-operative pain and narcotics usage. |  | First 3 days post-operatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bupivacaine, marcaine, lidocaine, normal saline, narcotics, analog pain scale, postoperative pain, preemptive, aerosolization, streamed