NCT00790829

Brief Summary

The efficacy of a low dose nicotine patch of seven milligrams placed before surgery and its effect on decreasing pain after surgery is the main purpose of the study.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 21, 2022

Status Verified

August 1, 2011

Enrollment Period

4 years

First QC Date

November 13, 2008

Last Update Submit

January 5, 2022

Conditions

Postoperative Pain

Keywords

preemptiveNicotine PatchOpen Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

  • The efficacy of a low dose nicotine patch of seven milligrams placed before surgery and its effect on decreasing pain after surgery is the main purpose of the study.

    24 hours

Study Arms (1)

A, B

EXPERIMENTAL

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

Drug: transdermal nicotine patch

Interventions

transdermal nicotine patchDRUG

Generic seven-milligram nicotine patches for 24hours, placebo patch for 24 hours

Also known as: Generic
A, B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tobacco Use Cessation DevicesDrugs, Generic

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsPharmaceutical Preparations

Study Officials

  • Ursula N Landman, DO

    Stony Brook University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 13, 2008

First Posted

November 14, 2008

Study Start

August 1, 2007

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

January 21, 2022

Record last verified: 2011-08

Locations

US(1)