Preemptive Use of the Nicotine Patch for Postoperative Pain Relief After Open Abdominal Surgery
Primary Purpose
Postoperative Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transdermal nicotine patch
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain focused on measuring preemptive, Nicotine Patch, Open Abdominal Surgery
Eligibility Criteria
Inclusion Criteria:
- Study patients include nonsmokers aged 18-75 undergoing open abdominal wall surgery under general anesthesia.
Exclusion Criteria:
- If the patient smokes, receives a regional anesthetic such as an epidural, or is pregnant, then he/she is excluded from the study.
Sites / Locations
- Stony Brook University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A, B
Arm Description
Group B received a seven-milligram transdermal patch and Group A received a placebo patch.
Outcomes
Primary Outcome Measures
The efficacy of a low dose nicotine patch of seven milligrams placed before surgery and its effect on decreasing pain after surgery is the main purpose of the study.
Secondary Outcome Measures
Full Information
NCT ID
NCT00790829
First Posted
November 13, 2008
Last Updated
January 5, 2022
Sponsor
Stony Brook University
1. Study Identification
Unique Protocol Identification Number
NCT00790829
Brief Title
Preemptive Use of the Nicotine Patch for Postoperative Pain Relief After Open Abdominal Surgery
Official Title
Preemptive Use of Nicotine Patch for Postoperative Pain Relief in Open Abdominal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The efficacy of a low dose nicotine patch of seven milligrams placed before surgery and its effect on decreasing pain after surgery is the main purpose of the study.
Detailed Description
Study patients include nonsmokers aged 18-75 undergoing open abdominal wall surgery under general anesthesia. If the patient smokes, receives a regional anesthetic such as an epidural, or is pregnant, then he/she is excluded from the study. There are two randomized study groups. Group B receives a seven-milligram transdermal patch and Group A receives a placebo patch. Generic seven-milligram nicotine patches or identical placebo patches made from band-aids are glued to a 3x4 inch adhesive pad and placed on the individuals' right upper arm 1 hour before surgery. All patients are given a standardized anesthetic consisting of a narcotic infusion, propofol, a neuromuscular blocking agent, anesthetic gas agent, antinauseant medication and a nonsteroidal.
Patients receive postoperative analgesia for twenty four hours after surgery with a narcotic or an additional nonsteroidal medication. All patients receive intravenous controlled patient controlled analgesia (IVPCA) with morphine sulfate one milligram per ten minutes, forty milligram four hour limit. Patients also receive toradol fifteen milligrams for breakthrough pain. The patch is removed from participants twenty four hours post IVPCA initiation. The following items are assessed every four hours for twenty four hours after post anesthesia care unit discharge: a verbal rating of pain, total IVPCA morphine use, nausea occurrence, vomiting occurrence, and sedation score by the nurse.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
preemptive, Nicotine Patch, Open Abdominal Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A, B
Arm Type
Experimental
Arm Description
Group B received a seven-milligram transdermal patch and Group A received a placebo patch.
Intervention Type
Drug
Intervention Name(s)
transdermal nicotine patch
Other Intervention Name(s)
Generic
Intervention Description
Generic seven-milligram nicotine patches for 24hours, placebo patch for 24 hours
Primary Outcome Measure Information:
Title
The efficacy of a low dose nicotine patch of seven milligrams placed before surgery and its effect on decreasing pain after surgery is the main purpose of the study.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Study patients include nonsmokers aged 18-75 undergoing open abdominal wall surgery under general anesthesia.
Exclusion Criteria:
If the patient smokes, receives a regional anesthetic such as an epidural, or is pregnant, then he/she is excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula N Landman, DO
Organizational Affiliation
Stony Brook University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Preemptive Use of the Nicotine Patch for Postoperative Pain Relief After Open Abdominal Surgery
We'll reach out to this number within 24 hrs