Effects of epidural lidocaine analgesia on labor and delivery
| ISRCTN | ISRCTN32569437 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32569437 |
| Secondary identifying numbers | 8112 |
- Submission date
- 26/04/2006
- Registration date
- 04/05/2006
- Last edited
- 05/01/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Shahram Nafisi
Scientific
Scientific
5th Kilometers of Ravand Road
Site Maskoni Pezeshkan
F1, No. 17
Kashan
-
Iran
Study information
| Study design | Interventional, randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Epidural analgesia for labor does not affect the duration of the first or second stages of labor |
| Ethics approval(s) | Ethics Committee of Kashan University of Medical sciences approved this research on 01/10/2002, reference number: 8112 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lidocaine, meperidine |
| Primary outcome measure | 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 study start date | 01/06/2004 |
| Completion date | 01/02/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 395 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2004 |
| Date of final enrolment | 01/02/2005 |
Locations
Countries of recruitment
- Iran
Study participating centre
5th Kilometers of Ravand Road
Kashan
-
Iran
-
Iran
Sponsor information
Kashan University of Medical Sciences (Iran)
University/education
University/education
15 Khordad Square
Setad Markazi Daneshgah
Kashan
-
Iran
| Website | http://www.kaums.ac.ir |
|---|---|
"ROR" |
https://ror.org/03dc0dy65 |
Funders
Funder type
University/education
Kashan University of Medical Sciences, Iran (8112)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 18/12/2006 | Yes | No |
