NCT00308841

CompletedPhase 1

Anesthetic Efficacy of Intrauterine Lidocaine for Removal of...

Suleyman Demirel University Source

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Other study identifiers

Sponsor study identifier

B.30.2.SDÜ.0.01.00.01.301.01

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Timeline

Study Start

Not reported

Date not reported

Primary Completion

Not reported

Date not reported

Study Completion

Not reported

Date not reported

Brief Summary

Objective: To evaluate the efficacy of intrauterine lidocaine instillation in reducing patient discomfort during the removal of a "lost" intrauterine device (IUD). Methods: This double-blinded, randomized, placebo-controlled trial included 68 women who underwent removal procedure for a "lost" IUD. Thirty-four women were allocated to the lidocaine group and 34 to the saline group. The main outcome measure was the intensity of pain during, immediately after, and 20 minutes after the procedure, assessed by a visual analog scale. Statistical analysis was performed using Friedman's test with Bonferroni correction, Student's t test, and 2.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 29, 2006
Actual (reported)
First Posted
March 30, 2006
Actual (reported)

Last Updated: October 20, 2008
Status Verified: September 2005
Last Update Submitted: October 17, 2008

Conditions

"Lost" IUD

Keywords

Objective: To evaluate the efficacy of intrauterine lidocaine instillation in reducing patient discomfort during the removal of a "lost" IUD

Interventions

Lidocaine (drug)Drug

Eligibility Criteria

Sexfemale

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

patients undergoing a minor gynecologic procedure for removal of a "lost" IUD.

You may not qualify if:

women with a history of cervical stenosis, known allergy to lidocaine, pregnancy, acute cervicitis

Sponsors & Collaborators

Suleyman Demirel University
Otherlead

Study Sites (1)

Süleyman Demirel University, School of Medicine

Isparta, 32100, Turkey (Türkiye)

Related Publications (1)

Guney M, Oral B, Mungan T. Efficacy of intrauterine lidocaine for removal of a "lost" intrauterine device: a randomized, controlled trial. Obstet Gynecol. 2006 Jul;108(1):119-23. doi: 10.1097/01.AOG.0000223201.42144.80.
PMID: 16816065RESULT

MeSH Terms

Interventions

LidocainePharmaceutical Preparations

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

Mehmet Güney, M.D
SDU
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER

Study Record Dates

First Submitted

March 29, 2006

First Posted

March 30, 2006

Last Updated

October 20, 2008

Record last verified: 2005-09

Source record

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Source: ClinicalTrials.gov.

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