Nicotine Patch as an Analgesic Adjuvant After Surgery

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440830
• Other study ID #: AAAB5945
• Status: Completed
• Phase: Phase 4
• Start date: December 2005
• Est. completion date: December 2008

Study information

• Verified date: September 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Adult ASA 1-2

Exclusion Criteria:

• Cardiovascular disease

• Former smoker

• Pregnant

• Nursing

• Asthma

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• nicotine patch
nicotine patch (0,5,10 or 15mg/day) applied to smokers
• nicotine patch
nicotine patch (0,5,10,or 15mg/day) applied to nonsmokers
• placebo
placebo patch applied to smokers
• placebo
placebo patch applied to nonsmokers

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center / New York Presbyterian	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sedation Level	Sedation may be monitored for the first hour, at the time of other data collection.	1 hour after surgery
Primary	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
Primary	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	Nausea Assessment by Patient	Nausea scale range: 0=none and 10=the worst, ordinal.	1 hour after surgery
Secondary	Pain Medication Used	Pain medication used after surgery in morphine equivalents	5 days
Secondary	Systolic Blood Pressure	Systolic blood pressure reported in Millimeters of Mercury (mmHg)	1 hour after surgery
Secondary	Diastolic Blood Pressure	Diastolic blood pressure reported in Millimeters of Mercury (mmHg)	1 hour after surgery
Secondary	Heart Rate	Heart rate reported in Beats per minute (BPM)	1 hour after surgery