NCT00308841

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.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2006

Completed
Last Updated

October 20, 2008

Status Verified

September 1, 2005

First QC Date

March 29, 2006

Last Update Submit

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Süleyman Demirel University, School of Medicine

Isparta, 32100, Turkey (Türkiye)

Location

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

Locations

TU(1)