Nicotine Patch as an Analgesic Adjuvant After Surgery

Study to Determine Whether the Use of a Nicotine Patch During the Day of Surgery Improves Postoperative Pain and Reduces Opioid Requirement

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: nicotine patch; Drug: nicotine patch; Drug: placebo; Drug: placebo

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center / New York Presbyterian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult ASA 1-2

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smokers-nicotine; Smokers who were treated with nicotine	Drug: nicotine patch; nicotine patch (0,5,10 or 15mg/day) applied to smokers; Other Names: nicotrol; Drug: nicotine patch; nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers; Other Names: nicotrol
Experimental: Nonsmokers-nicotine; Nonsmokers who were treated with nicotine	Drug: nicotine patch; nicotine patch (0,5,10 or 15mg/day) applied to smokers; Other Names: nicotrol; Drug: nicotine patch; nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers; Other Names: nicotrol
Placebo Comparator: Smokers-placebo; Smokers who were treated with placebo	Drug: placebo; placebo patch applied to smokers; Drug: placebo; placebo patch applied to nonsmokers
Placebo Comparator: Nonsmokers-placebo; Nonsmokers who were treated with placebo	Drug: placebo; placebo patch applied to smokers; Drug: placebo; placebo patch applied to nonsmokers

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation Level	Sedation may be monitored for the first hour, at the time of other data collection.	1 hour after surgery

Collaborators and Investigators

• Sponsor: Columbia University

Publications and helpful links

General Publications

• Olson LC, Hong D, Conell-Price JS, Cheng S, Flood P. A transdermal nicotine patch is not effective for postoperative pain management in smokers: a pilot dose-ranging study. Anesth Analg. 2009 Dec;109(6):1987-91. doi: 10.1213/ANE.0b013e3181bd1612.
• Hong D, Conell-Price J, Cheng S, Flood P. Transdermal nicotine patch for postoperative pain management: a pilot dose-ranging study. Anesth Analg. 2008 Sep;107(3):1005-10. doi: 10.1213/ane.0b013e318163204f.

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: February 26, 2007
• First Submitted That Met QC Criteria: February 26, 2007
• First Posted (Estimate): February 27, 2007

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: nausea; acute pain; sedation; nicotine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: AAAB5945