Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia
- Conditions
- Post-Dural Puncture Headache
- Interventions
- Drug: Intravenous normal saline
- Registration Number
- NCT06444737
- Lead Sponsor
- Mongi Slim Hospital
- Brief Summary
A prospective, bicentric, randomized, double-blind controlled study including parturients scheduled for elective caesarean delivery under spinal anaesthesia and randomized and assigned to one of the two groups:
Group O ondansetron : receiving Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia Group C control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia
OBJECTIVE :
To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.
- Detailed Description
Spinal anesthesia is the most common anesthetic technique used for Caesarean sections. However, it is not denied from complications.
Post-dural puncture headache is a major complication of spinal anesthesia, with an incidence ranging from 1.5% to 36%.
OBJECTIVE :
To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.
the investigators conducted a prospective, bicentric, randomized, double-blind controlled study over a period of 07 months from November 2023 to june 2024.
the investigators included in the study all parturients:
* Aged between 18-45 years
* ASA 2
* Between 37 and 41 weeks of gestation
* scheduled for elective caesarean delivery under spinal anaesthesia
* To be delivered by unscheduled caesarean section whose indication does not involve a vital maternal or fetal emergency, according to the Lucas' classification.
The eligible parturients were randomly assigned to two groups through block randomization using computerized random numbers.
were assigned to one of the two parallel groups to receive either :
* Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia : Group O (Ondansetron)
* Or IV normal saline 5 ml (control group) 5 min before spinal anesthesia : Group C (control)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- Aged between 18-45 years
- ASA 2
- Between 37 and 41 weeks of gestation
- scheduled for elective caesarean delivery under spinal anaesthesia
- To be delivered by unscheduled caesarean section whose indication does not involve a vital maternal or fetal emergency, according to the Lucas' classification
- All patients who required :
- more than two attempts for spinal anaesthesia
- conversion to general anesthesia following failure of spinal anesthesia (defined as a sensory block level <T6) or an intraoperative complication (such as hemorrhage or anaphylactic shock).
As well as patients who have subsequently withdrawn their consent for participating to our study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group O Intravenous ondansetron Group ondansetron : parturients receiving intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia Group C Intravenous normal saline Group control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia
- Primary Outcome Measures
Name Time Method Incidence of post-dural punction headache (PDPH) during the first seven postoperative days. 7 days the occurrence of positional headaches at any time postoperatively
- Secondary Outcome Measures
Name Time Method heart rate 3 days Mean arterial pressure during hospitalization
day of PDPH's occurence 7 days on postoperatively
day of PDPH's resolution 7 days on postoperatively
Mean arterial pressure in mmgh 3 days Mean arterial pressure during hospitalization
Need for analgesic treatment due to headaches 7 days paracetamol or NSAIDs
Occurrence of post-operative nausea and/or vomiting 7 days need of treatement
Headache severity 7 days assessed by the numerical pain scale from 0 to 10 (0 being no pain and 10 being the maximum unimaginable pain).
Trial Locations
- Locations (1)
Mongi slim hospital
🇹🇳Tunis, Tunisia