Comparison of the effects of intravenous ondansetron, paracetamol and both drugs in prevention of post-dural puncture headache following spinal anaesthesia for caesarean section;A double-blind randomised controlled trial.

To compare the effects of intravenous ondansetron, paracetamol, and both drugs in prevention of post dural puncture headache following spinal anaesthesia for caesarean section.

A total of 176 participants will be randomly divided into 4 groups of 44 per group. Superiority, parallel group trial with blinded outcome assessment will be used. Randomisation will be centralised and computerised with concealed randomisation sequence to be carried out at an external site.

The study centres will be UNTH ,ESUTTH and MCSH, Enugu. The trial will be double-blind study in which the study participants and outcome assessors will be blinded from knowing what intervention was given to the participants.

The participants' inclusion criteria comprised booked patient at term ,18 – 40-year-old and ASA I and II parturients undergoing elective caesarean section under spinal anaesthesia. The exclusion criteria comprised patients with known contraindication to spinal anaesthesia,allergy to the study drugs,patients with comorbidities like pregnancy induced hypertension, gestational diabetes mellitus, coronary artery disease or heart disease etc ,Patients converted into general anaesthesia,repeated dural punctures and patients who will decline consent to participate despite adequate counselling

A total of 176 participants booked for elective caesarean section will be randomly divided into 4 groups. Each group will comprise 44 participants. Groups 1,2,3 and 4 will receive 8mg of intravenous(IV) ondansetron only ,600mg of IV paracetamol, both IV ondansetron,8mg and paracetamol,600mg, and water for injection(placebo) respectively.

The primary outcome measure will be the incidence of post dural puncture headache within 24 hours following caesarean delivery.

The randomization of 176 pregnant women will be accomplished utilizing a computer-generated randomization schedule (Stat-Trek Generator), and placed into consecutively numbered, opaque, sealed envelopes. The eligible women will be assigned by means of these computer-generated random numbers into 4 sample groups; intervention group A ( will receive Ondansetron alone), intervention group B(will receive Paracetamol alone), intervention group C( will receive combination of ondansetron and paracetamol) and control group D(will receive water for injection) .Thus, once the patient is deemed eligible and has given informed consent, she will be assigned a sequential study number. Block randomization of all eligible consenting patients will be done using computer generated random sequence and a randomization ratio of 1:1:1: 1. Upon enrolment, an opaque envelope containing the patient enrolment number and assignment to any of the groups,will be opened and the unique number placed on the patient’s antenatal card. Each participant will be assigned a unique subject number for identity and confidentiality.

The participants and the outcome assessors will not know which injection will be given to any of the participants.

The data will be provided only on request.

It will be provided after publication of the project and last for 2 years

It will be provided to the publishing journal

For secondary analysis of the data and for understudy of the data by another researcher.

The journal that will publish the research work or by contacting Prof. Leonard O. Ajah through leonard.ajah@unn.edu.ng

It requires writing the corresponding author and stating the aim of the request of the data

Already stated above