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Comparison between Lidocaine-Prilocaine cream (EMLA) and lidocaine injection in the perineal pain relief during perineal repair in normal vaginal delivery

Protocol summary

Summary
This randomized clinical trial was done in 2011 at Shohada Tajrish hospital, Tehran, Iran. 46 primiparous women, with normal pregnancy after 37 weeks who refer for normal vaginal delivery with episiotomy, were selected and randomly assigned to either EMLA or lidocaine group. Three patients in EMLA group were excluded later because of emergency delivery or use of forceps. In EMLA group, 5 gr of cream was applied to the medio-lateral site of episiotomy one hour prior to the estimated delivery time at cervix dilatation of 9 cm and it cleaned just before delivery. No other material was used as anesthetics in this group. In addition, 5 gr of EMLA cream was used for repairing of episiotomy after delivery. In lidocaine group, 5 cc of lidocaine 2% were used for doing and later for repairing episiotomy. Demographic data, delivery characteristics, neonatal weight, repair duration, need to more anesthetics, pain during repair based on visual analog scale (VAS) and satisfaction from repair process were recorded and were compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014100219373N1
Registration date: 2014-11-09, 1393/08/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-11-09, 1393/08/18
Registrant information
Name
Roxana Kargar
Name of organization / entity
Avicenna Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2221 7065
Email address
afsanehnainie@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research -Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Lidocaine-Prilocaine cream (EMLA) and lidocaine injection in the perineal pain relief during perineal repair in normal vaginal delivery
Public title
Effect of EMLA cream and lidocaine injection in pain relief during perineal repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Primipara normal vaginal delivery with gestational age more than 37; normal pregnancy; single pregnancy; cephalic presentation Exclusion criteria: Multi-parity; sensitive to topical analgesics; need to epidural anesthesia; heart diseases; uncontrolled diabetes; neurological diseases which effect lower limb; use systemic or inhalation opium to reduce pain during labor
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences- Medical School
Street address
Daneshjoo St., Velenjak St.
City
Tehran
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
268

Health conditions studied

1

Description of health condition studied
Pain relief during perineal repair
ICD-10 code
O74
ICD-10 code description
Complications of anaesthesia during labour and delivery

Primary outcomes

1

Description
Pain relief during perineal repair in normal vaginal delivery
Timepoint
2 hour after delivery
Method of measurement
Visual Analog Scale (VAS)

Secondary outcomes

1

Description
Satisfaction from repair process
Timepoint
2 hours after delivery
Method of measurement
Asking patient

2

Description
Infection of episiotomy repair site
Timepoint
1 week after delivery
Method of measurement
Physical Examination

Intervention groups

1

Description
Control: 1. Using 5cc lidocaine 2% in mediolateral episiotomy site 10 minute prior to episiotomy 2. Using 5cc lidocaine 2% in mediolateral episiotomy site after delivery 3. Episiotomy repair after 10 minute
Category
Treatment - Drugs

2

Description
Intervention: 1. Using 5gr EMLA cream in mediolateral episiotomy site 1 hour prior to delivery (9cm cervix dilatation) 2. Using 5gr EMLA cream in around normal skin of episiotomy site after delivery 3. Episiotomy repair after 10 minute
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Dr. Roxnana Kargar
Street address
Tajrish Sq.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research -Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Roxana Kargar
Street address
Daneshjoo St., Velenjak St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research -Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Roxana Kargar
Position
Obstetrics & Gynecology Specialist
Other areas of specialty/work
Street address
Pole Roomi, Shariati St.
City
Tehran
Postal code
Phone
+98 21 2221 7065
Fax
Email
roxanakargar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Roxana Kargar
Position
Obstetrics & Gynecology Specialist
Other areas of specialty/work
Street address
Pole roomi, Shariati St.
City
Tehran
Postal code
Phone
+98 21 2221 7065
Fax
Email
roxanakargar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Roxana Kargar
Position
Obstetrics & Gynecology Specialist
Other areas of specialty/work
Street address
Pole Roomi, Shariati St.
City
Tehran
Postal code
Phone
+98 21 2221 7065
Fax
Email
roxanakargar@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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