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

NCT04657952 | Unknown Phase 4

• 1 other identifier: 34268/11/20
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sphenopalatine Ganglion Block; Adrenaline; Post-Dural Puncture Headache; Orthopedic; Randomized Controlled Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Onset of analgesia

  48 hours

• Duration of analgesia

  48 hours

• Adverse events

  48 hours

Study Arms (2)

Standard medical Treatment (paracetamol)

ACTIVE COMPARATOR

Patients will receive paracetamol 1 gm every 6 hours daily intravenously for a day.

Drug: Medical Treatment

Sphenopalatine block

EXPERIMENTAL

Patients will receive sphenopalatine block

Procedure: Sphenopalatine Ganglion Block

Interventions

Sphenopalatine Ganglion Block PROCEDURE

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.

Sphenopalatine block

Medical Treatment DRUG

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.

Standard medical Treatment (paracetamol)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Sphenopalatine Ganglion Block

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 8, 2020
• Study Start: December 10, 2020
• Primary Completion: May 10, 2021
• Study Completion: May 20, 2021
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: 3 months after completing the study