Efficacy of nebulised dexmedetomidine versus aminophylline for treatment of postdural puncture headache in patients undergoing subarachnoid block posted for caesarean section: a double-blind, randomised controlled study.

内容摘要

Postdural puncture headache (PDPH) following spinal anaesthesia significantly affects postpartum recovery. We evaluated the efficacy of nebulised dexmedetomidine and aminophylline in women with moderate to severe PDPH after caesarean delivery. In this single-centre, double-blind, randomised controlled trial, 96 postpartum women, with American Society of Anesthesiologists physical status II, Visual Analogue Scale (VAS), with PDPH (VAS>4; Lybecker>2) after subarachnoid block were allocated to receive nebulised dexmedetomidine (1&#x2009;&#xb5;g/kg), aminophylline (1.5&#x2009;mg/kg) or saline placebo. All participants received standardised conservative treatment and remained supine for 72&#x2009;hours. Nebulisation was administered two times per day for &#x2264;72&#x2009;hours. The primary endpoint was change in VAS pain score at 24 hours. Secondary endpoints included VAS and Lybecker scores at 48 hours and 72&#x2009;hours, Patient Global Impression of Change (PGIC) and adverse events. Baseline characteristics were comparable between groups. At 24&#x2009;hours, median VAS was significantly lower with dexmedetomidine (3 (3-4)) and aminophylline (4 (3-6)) compared with control (6 (5.5-6)) (p<0.001). Pain reduction persisted at 48 hours and 72&#x2009;hours, with dexmedetomidine producing the fastest resolution. Lybecker scores improved earlier in the treatment groups (p<0.001). PGIC showed 'very much improved' in 100% (dexmedetomidine), 53.1% (aminophylline) and 0% (control) (p<0.001). Adverse events were mild and infrequent, with cough and nausea occurring only in the aminophylline group. Nebulised dexmedetomidine and aminophylline provided effective, well-tolerated, non-invasive treatment for PDPH. Dexmedetomidine produced the greatest and earliest improvement. These therapies may represent practical alternatives for PDPH management in postpartum patients; larger multicentre trials allowing early mobilisation are warranted. Clinical Trials Registry-India (CTRI/2024/01/061322; date of prospective trial registration: 10 January 2024, date of first patient enrolment: 15 January 2024, https://ctri.nic.in/Clinicaltrials/login.php).