Comparison of severity of pain in continuous Epidural Infusion of Bupivacaine and Fentanyl versus Patient Controlled Analgesia techniques for Labor Analgesia
Patient controlled epidural analgesia, is a technique in which, patient can control her analgesic dosage, according to for pain intensity. There are several combined regimes with lower analgesic doses for better and safer control of labor pain. The aim of this study is to find an appropriate analgesic protocol for labor pain.
After approval from ethic Committee of Tabriz University and receiving informed consent, 60 pregnant patients candidate for vaginal delivery with lumbar epidural analgesia, will randomly allocate in two groups of 30.
An epidural catheter will be inserted for all patients via lumbar epidural technique and patients of two groups will receive primary loading dose of analgesic solution including bupivacaine 0.125% plus fentanyl 3 µg/ml (total volume of 10 ml) from epidural catheter. Patients of group one will receive background infusion of the analgesic solution with the rate of 8 ml/h via infusion pump. In the second group, patients will receive 2 ml of solution with pressing the button, and if needed, 8 ml of the analgesic solution will be administered to them according to the anesthesiologists order. Severity of pain will be evaluated with VAS (Visual Analogue Scale) scoring system 20 minute and then every 1 hour after beginning of analgesia, number and total dose of bupivacaine used during labor and delivery will be assessed and recorded with another person. In all patients upper sensory block limit, depth of motor block will be recorded. Data will be analyzed using SPSS version 17.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014121610765N6
Registration date:2016-07-08, 1395/04/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-08, 1395/04/18
Registrant information
Name
Sousan Rasooli
Name of organization / entity
Alzahra hospital/Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
rasoolis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center, Tabriz University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of severity of pain in continuous Epidural Infusion of Bupivacaine and Fentanyl versus Patient Controlled Analgesia techniques for Labor Analgesia
Public title
Comparison of Continuous Epidural Infusion of Bupivacaine and Fentanyl versus Patient Controlled Analgesia techniques for Labor Analgesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Parturients with 18-40 years of old; parturients with ASA Class I or II; consenting to be including to the study; women with active labor and vertex presentation
Exclusion criteria: Parturients with ASA Class III or higher; cardiovascular diseases; respiratory diseases; contraindication for epidural ; presentation other than vertex; patients with chronic pain and use of analgesics; diabetics
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethic Committee of Tabriz University of Medical Scienses
Street address
Golgasht Ave, Tabriz University of Medical Scienses,
City
Tabriz
Postal code
Approval date
2016-01-18, 1394/10/28
Ethics committee reference number
TBZMED.REC.1394.1046
Health conditions studied
1
Description of health condition studied
Labor pain
ICD-10 code
O80
ICD-10 code description
Single spontaneous delivery
2
Description of health condition studied
delivery
ICD-10 code
O84
ICD-10 code description
Multiple delivery
Primary outcomes
1
Description
pain
Timepoint
every 30 minutes from drug adminstration until delivery
Method of measurement
visual analog scale
Secondary outcomes
1
Description
motor block
Timepoint
every 30 minute from drug adminstration to delivery
Method of measurement
Modified Bromage scale
Intervention groups
1
Description
Patients of group one (group receiving continued infusion, 30 patients) will receive the blobs dose of solution that contain bupivacaine 0.125 plus fentanil 3µg/ml (total volume of 10 ml) through catheter, and they will receive background infusion ml/h 8 of same solution with infusion pump.
Category
Treatment - Drugs
2
Description
Patients of group two (30 patients)will receive the blobs dose of 10 ml from solution that contain bupivacaine 125 mg (26 ml bupivacaeine 0.5% and 100 µg fentanyl in 100 ml normal saline through catheter. This group has not background infusion, and patient will receive druge with press the button control of pump when need, and anesthesiologist will administer 8 ml of same solution when need to further analgesic.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Elahe Saheb Madarek
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for reaserch, Tabriz University of Medical Scienses
Full name of responsible person
Sousan Rasouli
Street address
Vice chancellor for reaserch, No 2, Central bulding of Tabriz University of Medical Scienses, Golgasht Ave
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for reaserch, Tabriz University of Medical Scienses
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
Reaserch center, Tabriz University of Medical Scienses
Full name of responsible person
Sousan Rasouli
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
Rasooli_s@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Reaserch Center, Tabriz University of Medical Scienses
Full name of responsible person
Sousan Rasouli
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
rasooli_s@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)