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

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.

Study Overview

• Status: Unknown
• Conditions: Pneumoperitoneum; Obesity; Pain, Postoperative; Postoperative Pain; Abdominal Pain
• Intervention / Treatment: Device: Intraperitoneal Aerosolization System, IntraMyst

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.

• Study Type: Interventional
• Enrollment: 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers Medical Center
    • Hoffman Estates, Illinois, United States, 60194
      • St. Alexius Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Northgate Technologies
• Investigators: Principal Investigator: Peter C. Rantis Jr., MD, Alexian Brothers Hospital Network

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Study Completion: August 1, 2006

Study Registration Dates

• First Submitted: February 1, 2006
• First Submitted That Met QC Criteria: February 1, 2006
• First Posted (Estimate): February 3, 2006

Study Record Updates

• Last Update Posted (Estimate): January 11, 2007
• Last Update Submitted That Met QC Criteria: January 9, 2007
• Last Verified: January 1, 2007

More Information

Terms related to this study

• Keywords: Laparoscopy; Laparoscopic Surgery; Gastric Bypass; Laparoscopic Surgical Procedures; Pain Measurement; Drug Delivery Systems
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Peritoneal Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pneumoperitoneum; Pain, Postoperative; Abdominal Pain
• Other Study ID Numbers: ABHN0635