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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by Northgate Technologies.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00286286
First Posted: February 3, 2006
Last Update Posted: January 11, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Northgate Technologies
February 1, 2006
February 3, 2006
January 11, 2007
February 2006
Not Provided
  • 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
  • 1.Baseline Pain score before surgery
  • 2.First Pain score upon arrival in PACU
  • 3.6 hrs after first recorded pain score
  • 4.12 hrs after first recorded pain score
  • 5.24 hrs after first recorded pain score
Complete list of historical versions of study NCT00286286 on ClinicalTrials.gov Archive Site
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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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
  • Pain, Postoperative
  • Postoperative Pain
  • Abdominal Pain
  • Obesity
  • Pneumoperitoneum
Device: Intraperitoneal Aerosolization System, IntraMyst
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
August 2006
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00286286
ABHN0635
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Northgate Technologies
Not Provided
Principal Investigator: Peter C. Rantis Jr., MD Alexian Brothers Hospital Network
Northgate Technologies
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP