Overview

This trial is active, not recruiting.

Conditions pain, postoperative, postoperative pain, abdominal pain, obesity, pneumoperitoneum
Treatment intraperitoneal aerosolization system, intramyst
Sponsor Northgate Technologies
Start date February 2006
End date August 2006
Trial size 50 participants
Trial identifier NCT00286286, ABHN0635

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
Baseline Pain score before surgery
time frame:
First Pain score upon arrival in PACU
time frame:
6 hrs after first recorded pain score
time frame:
12 hrs after first recorded pain score
time frame:
24 hrs after first recorded pain score
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: 1. Male or female patients between the ages of 18-65 2. Patients in general good health requiring elective surgery Exclusion Criteria: 1. Female patients that are pregnant 2. Patients allergic to bupivicaine 3. Patients who have used narcotic drugs within 30 days of the surgical procedure.

Additional Information

Official title Clinical Protocol for the Prospective Double Blind Randomised Controlled Trial for the Use of Intraperitoneal Aerosolized Local Anesthetic
Principal investigator Peter C. Rantis Jr., MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2007.
Information provided to ClinicalTrials.gov by Northgate Technologies.