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

January 5, 2022 updated by: Ursula Landman, Stony Brook University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A, B
Group B received a seven-milligram transdermal patch and Group A received a placebo patch.
Drug: transdermal nicotine patch
Generic seven-milligram nicotine patches for 24hours, placebo patch for 24 hours
Other Names:
  • Generic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Investigators

  • Principal Investigator: Ursula N Landman, DO, Stony Brook University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

November 13, 2008

First Submitted That Met QC Criteria

November 13, 2008

First Posted (Estimate)

November 14, 2008

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20075594

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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