To compare the effect of blocking the nerve present in the back of head and nerve present in nose for treatment of headache after spinal anaesthesia

Not yet recruiting

• Conditions: Spinal and epidural anesthesia-induced headache during the puerperium,

• Registration Number: CTRI/2023/12/060809
• Lead Sponsor: R Hravei

Brief Summary

PostDural Puncture Headache (PDPH) is a common and severe complication followingspinal anesthesia. Around10-20% of patients who have lumbar puncture for anyindication experience headache. Headacheis usually bilaterally symmetrical and is fronto-occipital in location, PDPH occurs due to leakage of cerebro-spinal fluid (CSF) at the site of duralpuncture that exceeds the spinal fluid production resulting in low CSFpressure, this traction precipitates symptoms on pain sensitive structures suchas meninges and blood vessels, cranial nerves and upper cervical nerves.

InitiallyPDPH is managed conservatively with bed rest, adequate hydration, analgesicanti-emetics and caffeine.

Epiduralblood patch (EBP) has been considered the gold standard treatment for severePDPH and when conservative measure failed. However, EBP is an invasive procedurewith failure rate of 15-20% worsening the PDPH by inadvertently creating thedural puncture rents.

Recently,minimally invasive methods like greater occipital nerve and Sphenopalatineganglion block had been used in the management of PDPH

This study aims to compare the efficacy of greater occipital nerveblock with sphenopalatine ganglion block for post dural puncture headache afterspinal anesthesia.

Our primary objective is tocompare the headache score by numerical rating score (NRS) in supine andupright position after intervention during 48 hours.

Thisstudy will be started after getting approval from Institutional EthicalCommittee. After explaining the proposed technique, informed consent will betaken from all patients. Conservative management Including bedrest, adequatehydration (oral/intravenous fluid) analgesics (inj. paracetamol IV 15mg/kg8hrly will be given to all patients with PDPH. The patients with headache scorepersist ≥4 even after conservative management will be included in the study.Baseline numerical rating score of headaches will be noted both in sitting andsupine position. Using a computer-generated randomization table, patients willbe randomly allocated into 2 groups.

Thetwo groups allocated are:

·GONB(Group A)–The patient will be placed in sittingposition with flexion of the neck. An imaginary line will be drawn fromexternal occipital protuberance to mastoid process and on the medial one thirdof the line, block will be performed using 2ml bupivacaine 0.5 % plus 4mg (1ml)dexamethasone on both sides.

·SPGB (Group B) –The patients willbe placed supine with shoulders slightly elevated to flex the neck and extendthe head. Long cotton nasal pack soaked with 2ml of bupivacaine 0.5% plus4mg(1ml) of dexamethasone will be placed intranasally in the sphenopalatineregion for 10 minutes.

Headachescore will be recorded before the block (baseline),30 minutes,1h, 2h, 6h, 12h,24h and 48h and at 1 week. After the intervention at any-time, if the headachescore >4/10 on NRS score in upright position, injection diclofenac 75mg willbe given as rescue analgesia and this will be considered as block failure. Ifthere is not adequate pain relief in 48h patient will be considered forepidural blood patch in the groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-15
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• BMI 18.5 to 24.9kg/m2.
• ASA class l and ll .
• Patient who developed PDPH with headache score more or equal to 4 on NRS.

Exclusion Criteria

Patient refusal,scalp infection, PIH, chronic headache, nasal polyp , DNS, epistaxis, major psychiatric condition.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Numerical rating scale headache score more or equal to 4	1 week

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction score	48 hours

Trial Locations

Locations (1)

Uttar Pradesh University of Medical Sciences; 🇮🇳 Etawah, UTTAR PRADESH, India

Uttar Pradesh University of Medical Sciences

🇮🇳Etawah, UTTAR PRADESH, India

Dr R Hravei

Principal investigator

9389588809

hraveipao50@gmail.com