Nicotine Patch as an Analgesic Adjuvant After Surgery

What Was Tested

This registered phase 4 trial tested Therapeutic nicotine (patch, non-peptide).

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

It had four arms (groups): Smokers-nicotine (experimental), Nonsmokers-nicotine (experimental), Smokers-placebo (placebo comparator) and Nonsmokers-placebo (placebo comparator).

Smokers who were treated with nicotine.

Nonsmokers who were treated with nicotine.

Smokers who were treated with placebo.

The registry classes the interventions as drug.

More on the Plan

Primary outcome variable is reported pain score (VAS), secondary is morphine PCA utilization, nausea, sedation, and hemodynamic changes.

Who Took Part

68 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult ASA 1-2.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: cardiovascular disease; former smoker.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2005-12 with completion listed for 2008-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Postoperative Pain Score One Hour After Surgery (time frame: 1 hour after surgery). Postoperative Pain Score Five Days After Surgery (time frame: 5 days).

It also tracked 5 secondary outcomes, for example Nausea Assessment by Patient, Pain Medication Used, Systolic Blood Pressure, Diastolic Blood Pressure and Heart Rate.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 68 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.