Sphenopalatine Ganglion Block for Post-Dural Puncture Headache in Orthopedic Patients

Phase 4

• Conditions: Randomized Controlled Study; Sphenopalatine Ganglion Block; Adrenaline; Post-Dural Puncture Headache; Orthopedic
• Interventions: Drug: Medical Treatment; Procedure: Sphenopalatine Ganglion Block

• Registration Number: NCT04657952
• Lead Sponsor: Tanta University

Brief Summary

The aim of this study is to assess the efficacy, onset and duration of analgesia of sphenopalatine ganglion bock (SPGB) using lidocaine 4% with adrenaline as a treatment of postoperative Post dural puncture headache (PDPH) of orthopedic patients after lower limbs surgeries.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-30
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-06
• Last Update Submitted: 2020-12-06
• Study First Posted: 2020-12-08
• Last Update Posted: 2020-12-08
• Study Start: 2020-12-10
• Primary Completion: 2021-05-10
• Study Completion: 2021-05-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Admitted to the orthopedic department
• Complaining of criteria of severe post-dural puncture headache within 7 days following subarachnoid block used for lower limbs surgeries.
• American Society of Anesthesiologists (ASA) physical status I and II.

Exclusion Criteria

• Patient refusal or uncooperative.
• Patients with uncontrollable hypertension.
• Patient with known coagulopathy.
• Patient with nasal septal deviation, polyp, history of nasal bleeding.
• Patient with allergy to local anesthetics
• American Society of Anesthesiologists physical status>2.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard medical Treatment (paracetamol)	Medical Treatment	Patients will receive paracetamol 1 gm every 6 hours daily intravenously for a day.
Sphenopalatine block	Sphenopalatine Ganglion Block	Patients will receive sphenopalatine block

Primary Outcome Measures

Name	Time	Method
Efficacy of analgesia demonstrated by visual analogue scale (VAS) less than 4 (effective) in the first 48 hours	48 hours	Efficacy of analgesia demonstrated by visual analogue scale (VAS) less than 4 (effective) in the first 48 hours.; VAS ranges from 0 to 10; 10 with worse outcome

Secondary Outcome Measures

Name	Time	Method
Adverse events	48 hours	Local anesthetic toxicity, hypertension, postoperative epistaxis, cheek hematoma and hypoesthesia of the palate
Onset of analgesia	48 hours	The onset time till VAS≥ 4
Duration of analgesia	48 hours	Duration with VAS\< 4