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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
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring preemptive, Nicotine Patch, Open Abdominal Surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
November 13, 2008
Last Updated
January 5, 2022
Sponsor
Stony Brook University
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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

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Preemptive Use of the Nicotine Patch for Postoperative Pain Relief After Open Abdominal Surgery

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