Intraperitoneal Aerosolized Delivery of a Local Anesthetic for Post Operative Pain Management. A Double Blind, Randomised Controlled Clinical Trial.
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Surgical Technique
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30 mls of 0.5% bupivacaine with epinephrine standard dose will be distributed into the trocar site wounds after desufflation of the peritoneal cavity.
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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.
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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.
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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 Design
Outcome Measures
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 []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female patients between the ages of 18-65
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Patients in general good health requiring elective surgery
Exclusion Criteria:
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Female patients that are pregnant
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Patients allergic to bupivicaine
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Patients who have used narcotic drugs within 30 days of the surgical procedure.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alexian Brothers Medical Center | Elk Grove Village | Illinois | United States | 60007 |
| 2 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ABHN0635