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

Sponsored by:	Northgate Technologies
Information provided by:	Northgate Technologies
ClinicalTrials.gov Identifier:	NCT00286286

Purpose

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.

Condition	Intervention
Pain, Postoperative Postoperative Pain Abdominal Pain Obesity Pneumoperitoneum	Device: Intraperitoneal Aerosolization System, IntraMyst

MedlinePlus related topics: Abdominal Pain Anesthesia Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	Clinical Protocol for the Prospective Double Blind Randomised Controlled Trial for the Use of Intraperitoneal Aerosolized Local Anesthetic

Further study details as provided by Northgate Technologies:

Primary Outcome Measures:

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

Estimated Enrollment:	50
Study Start Date:	February 2006
Estimated Study Completion Date:	August 2006

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286286

Locations

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

Sponsors and Collaborators

Northgate Technologies

Investigators

Principal Investigator:

Peter C. Rantis Jr., MD

Alexian Brothers Hospital Network

More Information

Study ID Numbers:	ABHN0635
Study First Received:	February 1, 2006
Last Updated:	January 9, 2007
ClinicalTrials.gov Identifier:	NCT00286286
Health Authority:	United States: Institutional Review Board

Keywords provided by Northgate Technologies:

Laparoscopy
Laparoscopic Surgical Procedures
Laparoscopic Surgery

Gastric Bypass
Drug Delivery Systems
Pain Measurement

Study placed in the following topic categories:

Obesity
Signs and Symptoms, Digestive
Abdominal Pain
Pain
Overweight
Body Weight
Signs and Symptoms

Digestive System Diseases
Postoperative Complications
Peritoneal Diseases
Nutrition Disorders
Overnutrition
Pneumoperitoneum
Pain, Postoperative

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009