Efficacy and safety of prophylactic intrathecal normal saline for prevention of Post Dural Puncture Headache among women undergoing cesarean section under spinal anesthesia: A randomized controlled trial

Abstract

Background: Post-Dural Puncture Headache is the commonest complication of spinal anesthesia. Body of evidence revealed that Conservative management failed to show significant benefit and epidural needle and catheter techniques didn’t provide conclusive evidence. On the other hand, intrathecal injection of normal saline is a simple technique and cost-effective in a resource-limited setup but it is not well examined on its effectiveness and safety profiles. Methods and materials: After Obtaining Ethical clearance from IRB, 152 mothers scheduled for cesarean section under spinal anesthesia were allocated randomly into two groups. Data analysis was done with SPSS version 22. Descriptive statistics were run to see the overall distribution of the study subjects. Unpaired student’s T-test for continuous symmetric data and Mann-Whitney U test for non-normally distributed data were used. Categorical data were analyzed with Chi-square and fisher’s exact test where appropriate. A generalized estimating equation model was used to investigate the interaction of repeated measurements of NRS pain scores of PDPH. Result: The overall incidence of PDPH was 29.6% while the proportion of patients who experienced PDPH was the highest among patients with control as compared to intervention( 36.8% vs 22%) respectively. The GEE model revealed that the NRS pain score was 0.7, 0.4, and 0.2 unit higher at 12, 24, and 48 respectively in control as compared to the intervention Conclusion: prophylactic intrathecal normal saline could be an option in a resource-limited setup where the appropriate spinal needle is not accessible and management of moderate and severe PDPH is not feasible Registration: The protocol was registered prospectively in Clinical Trials.gov (NCT04393766). Highlights

Post-dural puncture headache prevention and treatment with aminophylline or theophylline: a systematic review and meta-analysis

“…PDPH is one of the most common complications of lumbar puncture, which is usually accompanied by nausea, vomiting, stiff neck, hearing loss, tinnitus, and photophobia and may influence the quality of life and hospital discharge of patients [ 19 ]. There remains a great deal to learn regarding the pathophysiology of PDPH [ 35 ]. This headache is primarily due to a CSF leak following a dural puncture with resultant intracranial hypotension and, subsequently, downward traction on pain-sensitive intracranial structures caused by gravity in the standing position.…”