Intraperitoneal Aerosolized Delivery of a Local Anesthetic for Post Operative Pain Management. A Double Blind, Randomised Controlled Clinical Trial.
Recruitment status was Active, not recruiting
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Clinical Protocol for the Prospective Double Blind Randomised Controlled Trial for the Use of Intraperitoneal Aerosolized Local Anesthetic |
- 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 |
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 |
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| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00286286 History of Changes |
| Other Study ID Numbers: | ABHN0635 |
| Study First Received: | February 1, 2006 |
| Last Updated: | January 9, 2007 |
| 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 |
Additional relevant MeSH terms:
|
Abdominal Pain Obesity Pain, Postoperative Pneumoperitoneum Pain Signs and Symptoms Signs and Symptoms, Digestive Overnutrition Nutrition Disorders Overweight Body Weight Postoperative Complications |
Pathologic Processes Peritoneal Diseases Digestive System Diseases Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013