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

NCT ID: NCT00790829

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2011-12-31

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

A, B

Group B received a seven-milligram transdermal patch and Group A received a placebo patch.

Group Type: EXPERIMENTAL

transdermal nicotine patch

Intervention Type: DRUG

Generic seven-milligram nicotine patches for 24hours, placebo patch for 24 hours

Interventions

transdermal nicotine patch

Generic seven-milligram nicotine patches for 24hours, placebo patch for 24 hours

Intervention Type: DRUG

Other Intervention Names

Generic

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Ursula Landman

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ursula N Landman, DO

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University Hospital

Locations

Stony Brook University Hospital

Stony Brook, New York, United States

Countries

United States

Other Identifiers

20075594

Identifier Type: -

Identifier Source: org_study_id