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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Stony Brook University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00790829
First received: November 13, 2008
Last updated: August 11, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Postoperative Pain
Drug: transdermal nicotine patch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Preemptive Use of Nicotine Patch for Postoperative Pain Relief in Open Abdominal Surgery

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

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. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: August 2007
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Generic

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790829

Contacts
Contact: Ursula N Landman, DO 631-444-2975 ulandman@notes.cc.sunysb.edu
Contact: Ursula N Landman, DO 631-444-2975 Ulandman@notes.cc.sunysb.edu

Locations
United States, New York
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Judy Matuk    631-632-9036    jmatuk@notes.cc.sunysb.edu   
Contact: Ursula N Landman, DO    631-444-2975    ulandman@notes.cc.sunysb.edu   
Principal Investigator: Ursula N Landman, DO         
Sponsors and Collaborators
Stony Brook University
Investigators
Principal Investigator: Ursula N Landman, DO Stony Brook University Hospital
  More Information

No publications provided

Responsible Party: Ursula N. Landman, D.O./Principal Investigator, SUNY Stony Brook
ClinicalTrials.gov Identifier: NCT00790829     History of Changes
Other Study ID Numbers: 20075594
Study First Received: November 13, 2008
Last Updated: August 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Stony Brook University:
preemptive
Nicotine Patch
Open Abdominal Surgery

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014