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Sponsored by: |
Northgate Technologies |
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Information provided by: | Northgate Technologies |
ClinicalTrials.gov Identifier: | NCT00286286 |
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 |
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Pain, Postoperative Postoperative Pain Abdominal Pain Obesity Pneumoperitoneum |
Device: Intraperitoneal Aerosolization System, IntraMyst |
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 |
Estimated Enrollment: | 50 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | August 2006 |
Surgical Technique
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Alexian Brothers Medical Center | |
Elk Grove Village, Illinois, United States, 60007 | |
St. Alexius Medical Center | |
Hoffman Estates, Illinois, United States, 60194 |
Principal Investigator: | Peter C. Rantis Jr., MD | Alexian Brothers Hospital Network |
Study ID Numbers: | ABHN0635 |
Study First Received: | February 1, 2006 |
Last Updated: | January 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00286286 History of Changes |
Health Authority: | United States: Institutional Review Board |
Laparoscopy Laparoscopic Surgical Procedures Laparoscopic Surgery |
Gastric Bypass Drug Delivery Systems Pain Measurement |
Obesity Signs and Symptoms, Digestive Abdominal Pain Central Nervous System Depressants Anesthetics Pain Overweight Anesthetics, Local Body Weight |
Signs and Symptoms Digestive System Diseases Postoperative Complications Peritoneal Diseases Nutrition Disorders Overnutrition Peripheral Nervous System Agents Pneumoperitoneum Pain, Postoperative |
Obesity Signs and Symptoms, Digestive Abdominal Pain Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Pain Overweight Pharmacologic Actions Anesthetics, Local Body Weight Signs and Symptoms |
Digestive System Diseases Pathologic Processes Postoperative Complications Sensory System Agents Therapeutic Uses Peritoneal Diseases Nutrition Disorders Overnutrition Peripheral Nervous System Agents Central Nervous System Agents Pneumoperitoneum Pain, Postoperative |