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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
300
Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia
Intravenous normal saline 5 ml (control group) 5 min before spinal anesthesia
Mongi slim hospital
Tunis, Tunisia
RECRUITINGIncidence of post-dural punction headache (PDPH) during the first seven postoperative days.
the occurrence of positional headaches at any time postoperatively
Time frame: 7 days
day of PDPH's occurence
on postoperatively
Time frame: 7 days
day of PDPH's resolution
on postoperatively
Time frame: 7 days
Headache severity
assessed by the numerical pain scale from 0 to 10 (0 being no pain and 10 being the maximum unimaginable pain).
Time frame: 7 days
Need for analgesic treatment due to headaches
paracetamol or NSAIDs
Time frame: 7 days
Occurrence of post-operative nausea and/or vomiting
need of treatement
Time frame: 7 days
Mean arterial pressure in mmgh
Mean arterial pressure during hospitalization
Time frame: 3 days
heart rate
Mean arterial pressure during hospitalization
Time frame: 3 days
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