In this study, we evaluated the effect of intrathecal (IT) betamethasone as an adjunct to bupivacaine on postoperative pain in patients undergoing cesarean section. In a randomized, double-blind study, 99 patients undergoing cesarean section were randomly assigned to one of the following three groups. Group 1 (Control) received normal saline 0.5 ml IV with 3 ml of 0.5% heavy bupivacaine plus 0.5 ml of 0.9% saline intrathecally. Group 2 (IT) received normal saline 0.5 mL IV with 3 ml of 0.5% heavy bupivacaine plus 0.5 ml preservative free betamethasone (4 mg/ml) intrathecally. Group 3 (IV) received betamethasone 0.5 mL IV (4 mg/ml) with 3 ml of 0.5% heavy bupivacaine plus 0.5 ml of 0.9% saline intrathecally. After surgery, diclofenac 100 mg in suppository form was administrated as needed for analgesia. Postoperative diclofenac requirements, time to first analgesic administration and visual analogue scale (VAS) pain scores were recorded by a blinded observer.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012115363N1
Registration date:2011-01-28, 1389/11/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-28, 1389/11/08
Registrant information
Name
Taraneh Naghibi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 2865
Email address
tnaghibi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2009-10-23, 1388/08/01
Expected recruitment end date
2010-05-22, 1389/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Intrathecal Betamethasone on Post Operative Pain Relief after Cesarean Section in Mosavi Hospital.
Public title
The Effect of Intrathecal Betamethasone on Post Operative Pain Relief after Cesarean Section.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA class I and II, age between 20 and 40 years old, scheduled to undergo Cesarean Section
Exclusion criteria: Receiving analgesics or corticosteroids drugs, presence of contraindication to regional anesthesia, known hypersensitivity to the study drugs or if having any history of cardiac, respiratory, neuromuscular, Hepatic or renal disease, unwilling to participate
Age
From 20 years old to 40 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences
Street address
Azadi Blvd., Zanjan, Iran
City
Zanjan
Postal code
Approval date
2009-09-18, 1388/06/27
Ethics committee reference number
880627
Health conditions studied
1
Description of health condition studied
post operative pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
severity of pain
Timepoint
4, 6, 12, 24 h after operation
Method of measurement
VAS-consisting of 100 mm line with 0 = no pain and 100 = worst possible pain
Secondary outcomes
1
Description
number of used suppository
Timepoint
24 hrs after surgery
Method of measurement
Asking from Patient
2
Description
Nausea and vomiting intraoperatively
Timepoint
At the end of the surgery
Method of measurement
Asking from Patient
3
Description
Nausea and vomiting postoperatively
Timepoint
24 hrs after surgery
Method of measurement
Asking from Patient
4
Description
headache after surgery
Timepoint
24 hrs after surgery
Method of measurement
Asking from Patient
5
Description
Time to rescue analgesic drug for the first time
Timepoint
Whenever the VAS goes higher than 4
Method of measurement
Asking from Patient
Intervention groups
1
Description
Group 2 (IT): Visual analogue scale for pain was explained to all patients during the preoperative visit. In the operating room routine monitors were established (electrocardiogram, non-invasive blood pressure monitor and pulse oximeter). A 16 gauge intravenous canula was sited. An intravenous preload of 5 ml/kg of lactated Ringer’s solution was given before dural puncture. Spinal puncture was performed at the L3-4 space with a 23-gauge Quincke needle by using a midline approach. The patients received normal saline 0.5 mL IV with 3 ml of 0.5% heavy bupivacaine plus 0.5 ml preservative free betamethasone (4 mg/ml) intrathecally. After surgery, diclofenac, 100 mg in suppository form was administrated as needed for analgesia.
Category
Treatment - Drugs
2
Description
Group 1 (Control): Visual analogue scale for pain was explained to all patients during the preoperative visit. In the operating room, routine monitors were established (electrocardiogram, non-invasive blood pressure monitor and pulse oximeter). A 16 gauge intravenous canula was sited. An intravenous preload of 5 ml/kg of lactated Ringer’s solution was given before dural puncture. Spinal puncture was performed at the L3-4 space with a 23-gauge Quincke needle by using a midline approach. The patients received normal saline 0.5 mL IV with 3 ml of 0.5% heavy bupivacaine plus 0.5 ml of 0.9% saline intrathecally. After surgery, diclofenac, 100 mg in suppository form was administrated as needed for analgesia.
Category
Treatment - Drugs
3
Description
Group 3 (IV): Visual analogue scale for pain was explained to all patients during the preoperative visit. In the operating room routine monitors were established (electrocardiogram, non-invasive blood pressure monitor and pulse oximeter). A 16 gauge intravenous canula was sited. An intravenous preload of 5 ml/kg of lactated Ringer’s solution was given before dural puncture. Spinal puncture was performed at the L3-4 space with a 23-gauge Quincke needle by using a midline approach. The patients received betamethasone 0.5 mL IV (4 mg/ml) with 3 ml of 0.5% heavy bupivacaine plus 0.5 ml of 0.9% saline intrathecally. After surgery, diclofenac, 100 mg in suppository form was administrated as needed for analgesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mosavi hospital
Full name of responsible person
Dr Taraneh Naghibi
Street address
Mosavi hospital, Gavazang Blvd, Zanjan, Iran
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice- Chancellor for Research of Zanjan University
Full name of responsible person
Alireza Biglari MD, PhD
Street address
Office of Vice- Chancellor for Research, Zanjan University of Medical Sciences, Azadi Blvd
City
Zanjan
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 of Zanjan University
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
Zanjan University of Medical Sciences
Full name of responsible person
Dr Faramarz Dobakhti
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Faculty of pharmacy, Zanjan University of Medical Sciences
City
Zanjan
Postal code
Phone
+98 24 1427 3636
Fax
Email
fdobakhti@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Taraneh Naghibi
Position
Anesthesiologist- Assistant Professor
Other areas of specialty/work
Street address
Mosavi hospital, Gavazang Blvd, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 24 1424 2712
Fax
Email
tnaghibi@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Faramarz Dobakhti
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Faculty of pharmacy, Zanjan University of Medical Sciences
City
Zanjan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)