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

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ClinicalTrials.gov Identifier: NCT00286286
Recruitment Status : Unknown
Verified January 2007 by Northgate Technologies.
Recruitment status was:  Active, not recruiting
First Posted : February 3, 2006
Last Update Posted : January 11, 2007
Sponsor:
Information provided by:

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

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Clinical Protocol for the Prospective Double Blind Randomised Controlled Trial for the Use of Intraperitoneal Aerosolized Local Anesthetic
Study Start Date : February 2006
Estimated Study Completion Date : August 2006
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00286286     History of Changes
Other Study ID Numbers: ABHN0635
First Posted: February 3, 2006    Key Record Dates
Last Update Posted: January 11, 2007
Last Verified: January 2007

Keywords provided by Northgate Technologies:
Laparoscopy
Laparoscopic Surgical Procedures
Laparoscopic Surgery
Gastric Bypass
Drug Delivery Systems
Pain Measurement

Additional relevant MeSH terms:
Pain, Postoperative
Abdominal Pain
Pneumoperitoneum
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Peritoneal Diseases
Digestive System Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents