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OpenTrials
Completed

NCT Number: NCT00440830

Nicotine Patch as an Analgesic Adjuvant After Surgery

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

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Key information

Conditions

Pain Acute Pain Nausea Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Columbia University Irving Medical Center / New York Presbyterian

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult ASA 1-2

Exclusion criteria

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

Treatment and study plan

Nicotine patch

Drug

nicotine patch (0,5,10 or 15mg/day) applied to smokers

Other names: nicotrol

Placebo

Drug

placebo patch applied to smokers

Primary outcomes

  1. Postoperative Pain Score One Hour After Surgery

    Time frame: 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.

  2. Postoperative Pain Score Five Days After Surgery

    Time frame: 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 outcomes

  1. Nausea Assessment by Patient

    Time frame: 1 hour after surgery

    Nausea scale range: 0=none and 10=the worst, ordinal.

  2. Pain Medication Used

    Time frame: 5 days

    Pain medication used after surgery in morphine equivalents

  3. Systolic Blood Pressure

    Time frame: 1 hour after surgery

    Systolic blood pressure reported in Millimeters of Mercury (mmHg)

  4. Diastolic Blood Pressure

    Time frame: 1 hour after surgery

    Diastolic blood pressure reported in Millimeters of Mercury (mmHg)

  5. Heart Rate

    Time frame: 1 hour after surgery

    Heart rate reported in Beats per minute (BPM)

Other outcomes

  1. Sedation Level

    Time frame: 1 hour after surgery

    Sedation may be monitored for the first hour, at the time of other data collection.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Feb 27, 2007
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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