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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00286286
• Other study ID #: ABHN0635
• Status: Active, not recruiting
• Phase: N/A
• First received: February 1, 2006
• Last updated: January 9, 2007
• Start date: February 2006
• Est. completion date: August 2006

Study information

• Verified date: January 2007
• Source: Northgate Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Intraperitoneal Aerosolization System, IntraMyst

Locations

Country	Name	City	State
United States	Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	St. Alexius Medical Center	Hoffman Estates	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northgate Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Pain score before surgery
Primary	First Pain score upon arrival in PACU
Primary	6 hrs after first recorded pain score
Primary	12 hrs after first recorded pain score
Primary	24 hrs after first recorded pain score