Determining the effectiveness of nasal oxytocin on the prevention of post-dural pucture headache in women undergoing cesarean section
Design
2 Parallel groups with control group, double-blind, phase 3 on 170 patients, For randomization, the Random allocation software will be used.
Settings and conduct
1.The study will be performed in Kamali Hospital. Women who are candidates for elective cesarean section are admitted according to the inclusion criteria.
2. Exclusion of patients with exclusion criteria in pre-surgery visit by examination.
3. 170 women will be selected and They will be randomly divided into two groups.
5. Administration of 3 puffs (30IU) of nasal oxytocin to intervention group immediately after delivery, as a single dose and a dose of equal volume of normal saline, to the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Elective cesarean section candidates,
Exclusion criteria:
Known allergy to any of the studied drugs,
Hepatic, renal, cardiac dysfunction,
Severe obesity (BMI more than 35),
Neuromuscular disease,
History of lumbar discopathy / history of neuropathy,
opioids or analgesic usage 3 days before the study,
Consumption of calcium channel blockers,
Intervention groups
Intervention group: Receiving of 3 puffs (30IU) Nasal oxytocin (alborz drug company, made in Iran) Immediately after delivery
Controll group: Receiving of 3 puffs Nasal saline Immediately after delivery
Main outcome variables
The severity of headache after spinal anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201215049725N1
Registration date:2021-09-10, 1400/06/19
Registration timing:prospective
Last update:2021-09-10, 1400/06/19
Update count:1
Registration date
2021-09-10, 1400/06/19
Registrant information
Name
Saeed Hassanigelsefid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3275 5840
Email address
saeedhasani1372@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-29, 1400/07/07
Expected recruitment end date
2021-10-13, 1400/07/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Intranasal oxytocine spray effect on preventing post-dural puncture headache after elective cesarean section, A Clinical trial
Public title
Evaluation of Intranasal oxytocine spray effect on preventing post-dural puncture headache after cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Elective cesarean candidates
Exclusion criteria:
Allergies to drugs used in this study
BMI more than 35
Hepatic, renal or cardiac disorder
Neuromuscular disease
History of lumbar discopathy / history of neuropathy
Opioids or analgesic usage 3 days before the study
Consumption of calcium channel blockers
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
A randomized list will be generated using block randomization method with non-identical blocks of 2, 4 and 6 in two groups. This list will be generated by the following web address: https://www.sealedenvelope.com/simple-randomiser/v1/lists
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding, placebo will be used in the control group which has exact similar appearance with the medicine used in the intervention group. The physician who assess the outcome will not be aware of the patient's groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Unit. 5, No. 32, 20 metri resalat Ave, South Kuye Karmandan town, Karaj
City
Karaj
Province
Alborz
Postal code
3133746472
Approval date
2021-05-18, 1400/02/28
Ethics committee reference number
IR.ABZUMS.REC.1400.047
Health conditions studied
1
Description of health condition studied
post-dural puncture headache
ICD-10 code
O89.4
ICD-10 code description
Spinal and epidural anesthesia-induced headache during the puerperium
Primary outcomes
1
Description
headache severity after spinal anesthesia based on vas-score
Timepoint
12, 24, 48, 72 hours after cesarean section
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After cesarean section, The intervention group is given 3-puff (30IU) nasal oxytocin (Alborz Drug Company, Made in Iran) as a single dose immediately after delivery.
Category
Prevention
2
Description
Control group: After cesarean section, The Control group is given 3-puff nasal saline, which its appearance is exactly similar to oxytocin, as a single dose immediately after delivery.