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Sponsored by: |
Stony Brook University |
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Information provided by: | Stony Brook University |
ClinicalTrials.gov Identifier: | NCT00790829 |
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 |
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Postoperative Pain |
Drug: transdermal nicotine patch |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Preemptive Use of Nicotine Patch for Postoperative Pain Relief in Open Abdominal Surgery |
Estimated Enrollment: | 70 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A, B: Experimental
Group B received a seven-milligram transdermal patch and Group A received a placebo patch.
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Drug: transdermal nicotine patch
Generic seven-milligram nicotine patches for 24hours, placebo patch for 24 hours
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Ursula N Landman, DO | Stony Brook University Hospital |
Responsible Party: | SUNY Stony Brook ( Ursula N. Landman, D.O./Principal Investigator ) |
Study ID Numbers: | 20075594 |
Study First Received: | November 13, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00790829 History of Changes |
Health Authority: | United States: Institutional Review Board |
preemptive Nicotine Patch Open Abdominal Surgery |
Nicotine polacrilex Signs and Symptoms Neurotransmitter Agents Postoperative Complications Nicotine Nicotinic Agonists |
Central Nervous System Stimulants Pain Peripheral Nervous System Agents Cholinergic Agents Pain, Postoperative |
Nicotine polacrilex Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Nicotinic Agonists Physiological Effects of Drugs Central Nervous System Stimulants Pain Cholinergic Agents Pharmacologic Actions |
Signs and Symptoms Pathologic Processes Postoperative Complications Nicotine Autonomic Agents Therapeutic Uses Ganglionic Stimulants Peripheral Nervous System Agents Central Nervous System Agents Pain, Postoperative |