Anesthetic Efficacy of Intrauterine Lidocaine for Removal... | NCT00308841

Studies
Anesthetic Efficacy of Intrauterine Lidocaine for Removal of a "Lost" Intrauterine Device

NCT00308841

Sponsor

Suleyman Demirel University

Status

Completed

Last Update Posted

Oct 20, 2008Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

"Lost" IUD

Interventions

Lidocaine (drug)

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 29, 2006

First Submission Date that Met QC Criteria

Mar 29, 2006

First Posted Date

Mar 30, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2008

Last Update Posted Date

Oct 20, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine (drug)	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mehmet Güney, M.D	SDU	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Süleyman Demirel University, School of Medicine		Isparta		32100	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16816065	Result	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.

ID	Term
D008012	Lidocaine
D004364	Pharmaceutical Preparations

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814