Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia (OPDPH)

Mongi Slim Hospital

Status: Enrolling

Conditions: Post-Dural Puncture Headache

Treatments: Drug: Intravenous normal saline; Drug: Intravenous ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT06444737

ondansetron effect on PDPH

Details and patient eligibility

About

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.

Full 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)

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

300 participants in 2 patient groups, including a placebo group

Group O

Experimental group

Description:

Group ondansetron : parturients receiving intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia

Treatment:

Drug: Intravenous ondansetron

Group C

Placebo Comparator group

Description:

Group control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia

Treatment:

Drug: Intravenous normal saline