We decided to compare Epidural &TENS effects on progress and labour pain .
In this single blind study 105 parturients aged 20-40 years for vaginal delivery in Fatemy hospital in Hamadan in 2014-2015 after informed consent randomly (five person block)assigned to three groups (No=35).In Epidural group ,Epidural catheter is placed in active phase of labour (cervical dilation=5cm) and 10 ml lidocaine %1plus 1ml sufentanil is injected. In secondary stage, 15 ml lidocaine %1is injected by epidural catheter. In TENS group two pairs electrodes are placed in T0-L1&S2-S4 nerve roots. In first and second stages of labour electrodes connected to TENS device and set by 10-18 MA stimulation and 100 HZ frequency for 30 minutes .In control group, any methods is used but TENS electrodes are placed .In three groups vital signs and vas of labour pain in 5,10,15 &30 minutes after analgesia ,second stage of labour and after delivery are measured. Duration of first and secondary stage of labour ، nausea and vomiting ,itching, respiratory depression ,request to cesarean section ,patient satisfaction and neonatal apgar score are recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013071610841N5
Registration date:2016-04-23, 1395/02/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-23, 1395/02/04
Registrant information
Name
Nahid Manuchehrian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
manouchehrian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Hamadan University Of Medical Science
Expected recruitment start date
2014-07-02, 1393/04/11
Expected recruitment end date
2016-03-30, 1395/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparition effect of transcutaneous electrical nerve stimulation and epidural analgesia with lidocaine 1% on pain and prognosis of labour
Public title
Comparition of transcutaneous electrical nerve stimulation and epidural analgesia in labour pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Voluntarily participate in research; candidate for vaginal delivery; fetus cephalic presentation;term pregnancy;uncomplicated pregnancy;patients in active phase with >5cm dilation of cervix
Exclusion criteria: Cutaneous infection in back region (urticaria, insects and scar); previous cesarean section; patients with pacemaker;contraindications of epidural analgesia(couagolopathy ,hypovolemia,region cutaneous infection,increasing ICP and anemia)
Age
From 20 years old to 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan university of Medical Science
Street address
Fahmide Street
City
Hamadan
Postal code
6517838678
Approval date
2014-06-08, 1393/03/18
Ethics committee reference number
16/35/9/712/پ/د
Health conditions studied
1
Description of health condition studied
delivery
ICD-10 code
080.0
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
labour pain
Timepoint
5-10-15 and30 minutes after analgesia
Method of measurement
visual analgesic scale
2
Description
labour progress
Timepoint
labour duration
Method of measurement
duration of first and second stages of labour
3
Description
Heart Rate
Timepoint
5-10-15 and30 minutes after analgesia
Method of measurement
nomber of heart rate per minute
4
Description
systolic and diastolic blood presure
Timepoint
5-10-15 and30 minutes after analgesia
Method of measurement
non invasive bloon presure monitoring
5
Description
Tempreture
Timepoint
5-10-15 and30 minutes after analgesia
Method of measurement
Termometer
6
Description
new born Apgar
Timepoint
1&5 minutes after delivery
Method of measurement
Apgar Score
7
Description
Satisfactory
Timepoint
After delivery
Method of measurement
questioning
8
Description
Cesarean Section
Timepoint
Duration of labour
Method of measurement
Observation
Secondary outcomes
1
Description
Nausea & vomiting
Timepoint
during &after delivery
Method of measurement
Observation
2
Description
Itching
Timepoint
during &after delivery
Method of measurement
Observation &visual scale
3
Description
Respiratory Depression
Timepoint
during &after delivery
Method of measurement
Respiratory rate & Spo2
Intervention groups
1
Description
In Epidural group ,Epidural catheter is placed in active phase of labour(cervical dilation=5cm) and 10 ml lidocaine %1plus 1ml sufentanil is injected.In secondary stage,maximum 15 ml lidocaine %1is injected by epidural catheter.
Category
Prevention
2
Description
In TENS group two pairs electrodes are placed in T0-L1&S2-S4 nerve roots. In first and second stages of labour electrodes connected to TENS device and set by 10-18 MA stimulation and 100 HZ frequency for 30 minutes .
Category
Prevention
3
Description
In control group, any methods of analgesia is used but TENS electrodes are placed .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Nahid Manouchehrian
Street address
Pasdaran Street
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Hamadan University Of Medical Science
Full name of responsible person
Dr. saeed Bashirian
Street address
Fahmide Street
City
Hamadan
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 Hamadan University Of Medical Science
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
Hamadan University of Medical Science-Fatemie Hospital
Full name of responsible person
Dr. Nahid Manouchehrian
Position
associated professor of anesthesia Department
Other areas of specialty/work
Street address
Pasdaran Street
City
Hamadan
Postal code
65177-89971
Phone
+98 81 3827 7012
Fax
+98 81 3821 0171
Email
manouchehrian@umsha.ac.irmanuchehriann@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Science-Fatemie Hospital
Full name of responsible person
Dr. Nahid Manouchehrian
Position
Associated professor of Anesthesia Department
Other areas of specialty/work
Street address
Pasdaran Street
City
Hamadan
Postal code
65177-89971
Phone
+98 81 3827 7012
Fax
+98 81 3821 0171
Email
manouchehrian@umsha.ac.ir manuchehriann@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Science-Fatemie Hospital
Full name of responsible person
Dr. Nahid Manouchehrian
Position
Associated professor of Anesthesia Department
Other areas of specialty/work
Street address
Pasdaran Street
City
Hamadan
Postal code
65177-89971
Phone
+98 81 3827 7012
Fax
+98 81 3821 0171
Email
manouchehrian@umsha.ac.irmanuchehriann@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)