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

Sphenopalatine Ganglion Block With Adrenaline Additive for Post-Dural Puncture Headache in Orthopedic Patients: A Randomized Controlled Study

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard medical Treatment (paracetamol); Patients will receive paracetamol 1 gm every 6 hours daily intravenously for a day.	Drug: Medical Treatment; Patients will receive paracetamol 1 gm 6 hours daily intravenously for a day. If adequate pain relief will not be achieved, intravenous diclofenac 75 mg twice daily will be added.
Experimental: Sphenopalatine block; Patients will receive sphenopalatine block	Procedure: Sphenopalatine Ganglion Block; Sphenopalatine Ganglion Block will be performed by a transnasal approach. Few drops of lidocaine 2% will be instilled into both anterior nares. Then a cotton-tipped applicator soaked in 4% lignocaine & adrenaline (1 to 200000 will be passed through both the nares and the end of the applicator tip will be positioned just superior to the middle turbinate and anterior to the pterygopalatine fossa and sphenopalatine ganglion for 5 min with the patient in the supine position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of analgesia demonstrated by visual analogue scale (VAS) less than 4 (effective) in the first 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	48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 10, 2020
• Primary Completion (Anticipated): May 10, 2021
• Study Completion (Anticipated): May 20, 2021

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: December 6, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 6, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Pain; Neurologic Manifestations; Cysts; Connective Tissue Diseases; Mucinoses; Headache Disorders; Headache Disorders, Secondary; Headache; Ganglion Cysts; Synovial Cyst; Post-Dural Puncture Headache
• Other Study ID Numbers: 34268/11/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data will be available upon reasonable request
• IPD Sharing Access Criteria: 3 months after completing the study
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No