Clinical trial NCT06444737: Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia
Official title: Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia for Cesarean Sections : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Dural Puncture Headache
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of post-dural punction headache (PDPH) during the first seven postoperative days.
timeFrame: 7 days
Secondary outcomes:
measure: day of PDPH's occurence
timeFrame: 7 days
measure: day of PDPH's resolution
timeFrame: 7 days
measure: Headache severity
timeFrame: 7 days
measure: Need for analgesic treatment due to headaches
timeFrame: 7 days
measure: Occurrence of post-operative nausea and/or vomiting
timeFrame: 7 days
measure: Mean arterial pressure in mmgh
timeFrame: 3 days
measure: heart rate
timeFrame: 3 days
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Mongi slim hospital
Study officials:
References: