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

Post-Dural Puncture Headache Clinical Trial

— OPDPH  

Official title:

Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia for Cesarean Sections : A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06444737
• Other study ID #: ondansetron effect on PDPH
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: May 2024
• Source: Mongi Slim Hospital
• Contact: Mhamed Sami Mebazaa, professor
• Phone: 22252589
• Email: msmebazaa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache

Intervention

Drug:
• Intravenous ondansetron
Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia
• Intravenous normal saline
Intravenous normal saline 5 ml (control group) 5 min before spinal anesthesia

Locations

Country	Name	City	State
Tunisia	Mongi slim hospital	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Mongi Slim Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post-dural punction headache (PDPH) during the first seven postoperative days.	the occurrence of positional headaches at any time postoperatively	7 days
Secondary	day of PDPH's occurence	on postoperatively	7 days
Secondary	day of PDPH's resolution	on postoperatively	7 days
Secondary	Headache severity	assessed by the numerical pain scale from 0 to 10 (0 being no pain and 10 being the maximum unimaginable pain).	7 days
Secondary	Need for analgesic treatment due to headaches	paracetamol or NSAIDs	7 days
Secondary	Occurrence of post-operative nausea and/or vomiting	need of treatement	7 days
Secondary	Mean arterial pressure in mmgh	Mean arterial pressure during hospitalization	3 days
Secondary	heart rate	Mean arterial pressure during hospitalization	3 days