Condition category
Pregnancy and Childbirth
Date applied
26/04/2006
Date assigned
04/05/2006
Last edited
05/01/2007
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 Shahram Nafisi

ORCID ID

Contact details

5th Kilometers of Ravand Road
Site Maskoni Pezeshkan
F1
No. 17
Kashan
-
Iran

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8112

Study information

Scientific title

Acronym

Study hypothesis

Epidural analgesia for labor does not affect the duration of the first or second stages of labor

Ethics approval

Ethics Committee of Kashan University of Medical sciences approved this research on 01/10/2002, reference number: 8112

Study design

Interventional, randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Labor pain

Intervention

197 women were randomized to receive epidural with bolus doses of 1% lidocaine, 198 women were randomized to receive single-dose intravenous meperidine 25 to 50 mg

Intervention type

Drug

Phase

Not Specified

Drug names

Lidocaine, meperidine

Primary outcome measures

Epidural analgesia for labor does not prolong the first or second stages of labor

Secondary outcome measures

Epidural analgesia for labor does not affect neonatal apgar score

Overall trial start date

01/06/2004

Overall trial end date

01/02/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Nulliparity
2. Active labor
3. Cervical dilatation ≥4 cm
4. Single fetus with vertex presentation
5. American Society of Anesthesiologists (ASA) status 1
6. Request for analgesia

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

395

Participant exclusion criteria

1. ASA status >2
2. Age <19 years old
3. Receiving analgesia prior to enrolment
4. Accidental dural puncture
5. Multiparity
6. Probable cephalopelvic disproportion on pelvic examination
7. Cervical dilatation to >4 cm

Recruitment start date

01/06/2004

Recruitment end date

01/02/2005

Locations

Countries of recruitment

Iran

Trial participating centre

5th Kilometers of Ravand Road
Kashan
-
Iran

Sponsor information

Organisation

Kashan University of Medical Sciences (Iran)

Sponsor details

15 Khordad Square
Setad Markazi Daneshgah
Kashan
-
Iran

Sponsor type

University/education

Website

http://www.kaums.ac.ir

Funders

Funder type

University/education

Funder name

Kashan University of Medical Sciences, Iran (8112)

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

Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17176461

Publication citations

  1. Results

    Nafisi S, Effects of epidural lidocaine analgesia on labor and delivery: a randomized, prospective, controlled trial., BMC Anesthesiol, 2006, 6, 15, doi: 10.1186/1471-2253-6-15.

Additional files

Editorial Notes