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Comparison of the analgesic efficacy of sphenopalatine ganglion block and dexmedetomidine nebulization for treatment of post-dural puncture headache obstetric patients.

Comparative evaluation of sphenopalatine ganglion block and dexmedetomidine nebulization for treatment of post-dural puncture headache in obstetric patients. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073836
Enrollment
70
Registered
2024-09-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O94-O9A- Other obstetric conditions, not elsewhere classified

Interventions

Intervention1: Sphenopalatine Ganglion (SPG) Block for treatment of obstetric Post-Dural Puncture Headache (PDPH): Trans-nasal cotton-tipped swab applicator soaked in 2% lidocaine is inserted into the

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult Parturient with PDPH defined as a moderate to severe NRS pain score of =4 in an upright position that developed within 5 days after an intended or accidental dural puncture. 2. The headache must have persisted for at least 1 day after the Dural puncture and must have been intractable to treatment with fluid and paracetamol.

Exclusion criteria

Exclusion criteria: 1. Patients not giving consent for the study 2. Hypertensive disorders of Pregnancy 3. Known allergy to local anesthetics 4. Cardiac abnormalities and heart Failure 5. History of chronic headache, migraine, convulsions and cerebrovascular accident 6. History of nasal bleed, deviated nasal septum, nasal polyp

Design outcomes

Primary

MeasureTime frame
1.Comparison of Numerical Rating Scale (NRS) for pain at 1 hour in Sphenopalatine Ganglion (SPG) Block and Nebulized dexmedetomidine groups after intervention. Timepoint: Analgesic efficacy will be assessed after 1 hour in both groups : Sphenopalatine ganglion block (SPGB) and Dexmedetomidine nebulization after intervention.

Secondary

MeasureTime frame
(Includes comparison between patients receiving SPG block & Nebulized dexmedetomidine.) 1. NRS scores at 30 minutes,2,6,12 & 24 hours. 2. Mean Flow velocity & Pulpability index in the middle cerebral artery at baseline,1,6 & 24 hours with Trans-cranial Doppler (TCD) 3. Patient satisfaction score at 24 hours. 4. Occurrence of any adverse effects. 5. Onset of analgesia & duration of action. Timepoint: Numerical Rating Scale (NRS) pain score at baseline, 30 minutes, 2, 6, 12, & 24 hours. Mean Flow Velocity & Pulsatility index with transcranial Doppler at baseline, 1, 6, & 24 hours after intervention. All patients will be followed up to 24 hours after recruiting for the study

Countries

India

Contacts

Public ContactKamal Kant Chaudhary

All India Institute of Medical Sciences, New Delhi

drshail.kumar@gmai.com8745027472

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026