Nicotine Patch as an Analgesic Adjuvant After Surgery

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: nicotine patch; Drug: placebo

• Registration Number: NCT00440830
• Lead Sponsor: Columbia University

Brief Summary

Effect of nicotine patch as an adjutant for acute pain after surgery.

Detailed Description

This is a dose finding trial for nicotine patches as analgesics. Doses used are 5mg/ 10mg/ 15mg or placebo. Primary outcome variable is reported pain score (VAS), secondary is morphine PCA utilization, nausea, sedation, and hemodynamic changes.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2007-02-26
• Study First Submitted QC: 2007-02-26
• Study First Posted: 2007-02-27
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2010-10-01
• Results First Submitted QC: 2010-10-01
• Results First Posted: 2010-10-27
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Adult ASA 1-2

Exclusion Criteria

• Cardiovascular disease
• Former smoker
• Pregnant
• Nursing
• Asthma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nonsmokers-nicotine	nicotine patch	Nonsmokers who were treated with nicotine
Smokers-placebo	placebo	Smokers who were treated with placebo
Nonsmokers-placebo	placebo	Nonsmokers who were treated with placebo
Smokers-nicotine	nicotine patch	Smokers who were treated with nicotine

Primary Outcome Measures

Name	Time	Method
Postoperative Pain Score One Hour After Surgery	1 hour after surgery	Postoperative pain reported after the first hour using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.
Postoperative Pain Score Five Days After Surgery	5 days	Postoperative pain reported after five days using a standard numerical rating scale (NRS) with 0=no pain and 10=worst pain imaginable.

Secondary Outcome Measures

Name	Time	Method
Nausea Assessment by Patient	1 hour after surgery	Nausea scale range: 0=none and 10=the worst, ordinal.
Heart Rate	1 hour after surgery	Heart rate reported in Beats per minute (BPM)
Pain Medication Used	5 days	Pain medication used after surgery in morphine equivalents
Systolic Blood Pressure	1 hour after surgery	Systolic blood pressure reported in Millimeters of Mercury (mmHg)
Diastolic Blood Pressure	1 hour after surgery	Diastolic blood pressure reported in Millimeters of Mercury (mmHg)

Trial Locations

Locations (1)

Columbia University Irving Medical Center / New York Presbyterian; 🇺🇸 New York, New York, United States