Intraperitoneal Aerosolized Delivery of a Local Anesthetic for Post Operative Pain Management. A Double Blind, Randomised Controlled Clinical Trial.

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness of aerosolized pain medication (.5% bupivicaine) delivered into the peritoneal cavity after laparoscopic gastric bypass surgery. This double blind study will include 50 patients. 25 will receive the aerosolized pain medication and 25 will receive a placebo (normal saline). All 50 patients will receive routine/typical methods of post-operative pain management. Post operative pain scores of the patients will be examined to determine the effect of aerosolization.

Detailed Description
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Surgical Technique 30 mls of 0.5% bupivacaine with epinephrine standard dose will be distributed into the trocar site wounds after desufflation of the peritoneal cavity. All the patients will be under a consistent intra-abdominal pressure using CO2 and the laparoscopy will be carried out using the same, routine / typical surgical instruments. A. Control Group (n=25): Aerosolized normal saline will be introduced at the end of the procedure, using a specially designed sterile catheter. The catheter will be inserted via trocar port under direct vision. The other end of the catheter will be connected to a 72 Edwards Lifesciences pressure tubing (Ref: 50P172), which will be connected to a B&D 20cc syringe filled with 15 ml of normal saline and inserted into a specially designed syringe pump and pressurizing system designed to aerosolize the specified agent. The total dose of patient delivered normal saline will be 10 ml, with 5 ml remaining contained and undelivered within the catheter and 72 pressure tubing. Routine/Typical methods of post-operative pain management will be employed. B. Aerosolized anesthetic (n=25): at the end of the procedure, the aerosolized local anesthetic will be introduced using a specially designed sterile catheter. The catheter will be inserted via trocar port under direct vision. The other end of the catheter will be connected to a 72 Edwards Lifesciences pressure tubing (Ref: 50P172), which will be connected to a B&D 20cc syringe filled with 15 ml of anesthetic agent and inserted into a specially designed syringe pump and pressurizing system designed to aerosolize the specified agent. The total dose of patient delivered anesthetic will be 10 ml, with 5 ml remaining contained and undelivered within the catheter and 72 pressure tubing. Routine/Typical methods of post-operative pain management will be employed.

Official Title
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Clinical Protocol for the Prospective Double Blind Randomised Controlled Trial for the Use of Intraperitoneal Aerosolized Local Anesthetic

Conditions
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Pain, Postoperative, Postoperative Pain, Abdominal Pain, Obesity, Pneumoperitoneum

Intervention / Treatment
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* Device: Intraperitoneal Aerosolization System, IntraMyst


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients between the ages of 18-65 Patients in general good health requiring elective surgery Exclusion Criteria: Female patients that are pregnant Patients allergic to bupivicaine Patients who have used narcotic drugs within 30 days of the surgical procedure.

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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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: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Intraperitoneal Aerosolization System, IntraMyst|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Pain score before surgery |  |  | 
| First Pain score upon arrival in PACU |  |  | 
| 6 hrs after first recorded pain score |  |  | 
| 12 hrs after first recorded pain score |  |  | 
| 24 hrs after first recorded pain score |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, Laparoscopic Surgical Procedures, Laparoscopic Surgery, Gastric Bypass, Drug Delivery Systems, Pain Measurement