Condition category
Surgery
Date applied
08/05/2005
Date assigned
08/07/2005
Last edited
10/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Manee Rattanachaiyanont

ORCID ID

Contact details

Department of Obstetrics and Gynecology
Faculty of Medicine
Siriraj Hospital
2 Prannok Rd.
Bangkoknoi
Bangkok
10700
Thailand

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

IUA

Study hypothesis

Compared with paracervical block alone, intrauterine anesthesia plus paracervical block would reduce maximum pain during fractional curettage for at least 2 cm, as measured by a 10-cm visual analogue score

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Local anesthesia for fractional curettage

Intervention

Intrauterine lidocaine plus paracervical block (experimental group) compared with intrauterine saline plus paracervical block (control group)

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

The reduction of a maximum pain score during fractional curettage.

Secondary outcome measures

Secondary outcomes included pain profile during fractional curettage, number of patients with pain score >4 cm, patients’ global satisfaction, types and incidence of adverse events, and serum lidocaine profile.

Overall trial start date

01/04/2003

Overall trial end date

31/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Women with abnormal uterine bleeding scheduled for fractional curettage.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

70

Participant exclusion criteria

Patients who had the American Society of Anesthesiologists (ASA) physical status >II, genital organ infection, profuse uterine bleeding, a history of lidocaine hypersensitivity, a history of impaired liver function, were virgin, pregnant, or unable to understand how to score a 10-cm visual analogue scale (VAS) pain score.

Recruitment start date

01/04/2003

Recruitment end date

31/10/2003

Locations

Countries of recruitment

Thailand

Trial participating centre

Department of Obstetrics and Gynecology
Bangkok
10700
Thailand

Sponsor information

Organisation

Mahidol University - Siriraj Grant for Research Development (Thailand)

Sponsor details

Faculty of Medicine
Siriraj Hospital
Mahidol University
2 Prannok Rd.
Bangkoknoi
Bangkok
10700
Thailand

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Siriraj Grant for Research Development, Faculty of Medicine, Siriraj Hospital (Thailand)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16135583

Publication citations

  1. Results

    Rattanachaiyanont M, Leerasiri P, Indhavivadhana S, Effectiveness of intrauterine anesthesia for pain relief during fractional curettage., Obstet Gynecol, 2005, 106, 3, 533-539, doi: 10.1097/01.AOG.0000172424.09992.3e.

Additional files

Editorial Notes