Magnesium Sulfate Versus Gabapentin for Post-Dural Puncture Headache After Spinal Anesthesia for Cesarean Delivery

This study aims to compare Gabapentin and Magnesium Sulfate for reduction of headache intensity in patients who undergo cesarean surgery with spinal anesthesia, in which the dura in punctured and causes Post-Dural Puncture Headache (PDPH).

Single-center, two-arm, parallel-group, Phase 3 randomized superiority clinical trial (n=84; 42 per group) comparing intravenous magnesium sulfate with oral gabapentin for post-dural puncture headache. Randomization will be performed using permuted blocks of four, with blinded outcome assessment and statistical analysis.

The trial will be conducted at Ayatollah Mousavi Hospital, Zanjan, Iran. Women who develop post-dural puncture headache following elective cesarean delivery under spinal anesthesia will either receive 600 mg oral gabapentin or 2 g intravenous magnesium sulfate. Headache severity will be assessed using VAS at baseline and 1, 6, 12, 24, and 48 hours after treatment. Rescue analgesic use and adverse events will be recorded.

Inclusion criteria: Women aged 18–45 years with American Society of Anesthesiologists (ASA) physical status I–II who developed post-dural puncture headache (PDPH) following spinal anesthesia for elective cesarean delivery and provided written informed consent. Exclusion criteria: History of preoperative headache, preeclampsia, eclampsia, or hypertension; contraindications to spinal anesthesia; known hypersensitivity to gabapentin or magnesium sulfate; conversion to general anesthesia; development of focal neurological signs; suspected alternative causes of headache; or withdrawal of consent.

1. Gabapentin 2. Magnesium Sulfate

Reduction in Visual Analogue Scale (VAS) for pain experienced by the patient

Eligible participants will be allocated in a 1:1 ratio to magnesium sulfate or gabapentin using permuted blocks of four. Treatment groups will be coded during outcome assessment and analysis. The unit of randomization will be a patient. Online software from SealedEnvelope.com will be used for creation of the blocks. Allocation concealment will be carried out by sequentially numbered, opaque, sealed envelopes (SNOSE).

Because the interventions differ in route of administration (intravenous versus oral), participants and the staff member administering the assigned treatment will not be blinded. A study assistant who's aware of allocation, administers the treatment; whereas the physician assessing outcomes and the statistician were blinded to treatment identity through coded group labels.

1. Study Protocol Protocol of the randomized clinical trial comparing intravenous magnesium sulfate and oral gabapentin for post-dural puncture headache following cesarean delivery. Includes study design, eligibility criteria, randomization, interventions, and outcome assessments. 2. Statistical Analysis Plan Statistical analysis plan describing baseline characteristics, longitudinal VAS analysis using generalized estimating equations (GEE), between-group comparisons, rescue analgesic use, and adverse event analysis. 3. Informed Consent Form Blank informed consent form describing the study objectives, procedures, potential risks and benefits, confidentiality, and voluntary participation. No signed forms or identifiable participant information will be shared. 4. Clinical Study Report Final clinical study report containing study methodology, participant characteristics, treatment outcomes, statistical results, adverse events, and study limitations. Sharing arrangements: All four documents will be available in PDF format upon reasonable request to the corresponding author after publication of the main study results.

The data will become available after publication of the main study results.

The data approved above to be shared, will be shared upon reasonable request after publication of the main results of the study with researchers active in this field.

Study documents will be shared upon reasonable written request to the corresponding author after publication of the main results. Requests should specify the applicant’s affiliation, intended purpose, and proposed use. Access will be granted for legitimate academic research, methodological evaluation, evidence synthesis, or educational purposes, subject to review by the corresponding author. Appropriate citation, confidentiality, and non-redistribution are required. No identifiable participant information or signed consent forms will be shared. Individual participant data (IPD) are not included in this sharing plan.

Study documents will be available upon reasonable request to the corresponding author after publication of the main results. Requests should preferably be submitted by email. Contact person: Nazaninsadat Kakatafti Email: nazi.kaka72@gmail.com

Applicants should email the corresponding author, specifying their name, institutional affiliation, requested documents, and intended use. Requests will be reviewed for scientific relevance and compliance with confidentiality requirements within 10 working days. Approved documents will be provided electronically in PDF format within 5 additional working days. The expected processing time is 10–15 working days, unless further clarification or institutional approval is required.