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
Duration of analgesia	48 hours	Duration with VAS\< 4
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