NCT00286286

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: Northgate Technologies · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Surgical Technique 1. 30 mls of 0.5% bupivacaine with epinephrine standard dose will be distributed into the trocar site wounds after desufflation of the peritoneal cavity. 2. 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.

Conditions

• Pain, Postoperative
• Postoperative Pain
• Abdominal Pain
• Obesity
• Pneumoperitoneum

Interventions

Type	Name	Description
DEVICE	Intraperitoneal Aerosolization System, IntraMyst

Timeline

• Start date: 2006-02-01
• Completion: 2006-08-01
• First posted: 2006-02-03
• Last updated: 2007-01-11

Locations

2 sites across 1 country: United States