Preemptive Use of the Nicotine Patch for Postoperative Pain Relief After Open Abdominal Surgery

Plain-language guide to NCT00790829: not phased interventional trial of Therapeutic nicotine (patch, non-peptide), 30 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00790829
Phase: not phased
Status: terminated early
Start: 2007-08
Completion (planned or actual): 2011-08
Participants: 30 (actual)
Design: na, open label (everyone knows who gets what), prevention
Conditions studied: Postoperative Pain
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had 1 arm (groups): A, B (experimental).

Group B received a seven-milligram transdermal patch and Group A received a placebo patch.

The registry classes the interventions as drug.

More on the Plan

Study patients include nonsmokers aged 18-75 undergoing open abdominal wall surgery under general anesthesia.

If the patient smokes, receives a regional anesthetic such as an epidural, or is pregnant, then he/she is excluded from the study.

There are two randomized study groups.

Group B receives a seven-milligram transdermal patch and Group A receives a placebo patch.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Study patients include nonsmokers aged 18-75 undergoing open abdominal wall surgery under general anesthesia.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: if the patient smokes, receives a regional anesthetic such as an epidural, or is pregnant, then he/she is excluded from the study.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2007-08 with completion listed for 2011-08.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What This Means in Plain Language

Put simply, this is a not phased trial of Therapeutic nicotine (patch, non-peptide) in 30 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Therapeutic nicotine (patch, non-peptide): Pure nicotine as a signaling tool, separated from smoking and vaping.

Therapeutic nicotine (patch, non-peptide) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.