Post-Dural Puncture Headache
Conditions
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)
Interventions
Intravenous normal saline 5 ml (control group) 5 min before spinal anesthesia
Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia
Sponsors
Mongi Slim Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| day of PDPH's resolution | 7 days | on postoperatively |
| 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). |
| Need for analgesic treatment due to headaches | 7 days | paracetamol or NSAIDs |
| day of PDPH's occurence | 7 days | on postoperatively |
| Mean arterial pressure in mmgh | 3 days | Mean arterial pressure during hospitalization |
| heart rate | 3 days | Mean arterial pressure during hospitalization |
| Occurrence of post-operative nausea and/or vomiting | 7 days | need of treatement |
Countries
Tunisia
Contacts
Primary ContactMhamed Sami Mebazaa, professor
Backup ContactAmani Ben Haj Youssef, assistant
Outcome results
None listed