Clinical Trials Directory

Trials / Terminated

TerminatedNCT00790829

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

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Stony Brook University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGtransdermal nicotine patchGeneric seven-milligram nicotine patches for 24hours, placebo patch for 24 hours

Timeline

Start date
2007-08-01
Primary completion
2011-08-01
Completion
2011-12-01
First posted
2008-11-14
Last updated
2022-01-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00790829. Inclusion in this directory is not an endorsement.