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

Post-Dural Puncture Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04657952
• Other study ID #: 34268/11/20
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 10, 2020
• Est. completion date: May 20, 2021

Study information

• Verified date: December 2020
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 20, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Onset of analgesia	The onset time till VAS= 4	48 hours
Secondary	Duration of analgesia	Duration with VAS< 4	48 hours
Secondary	Adverse events	Local anesthetic toxicity, hypertension, postoperative epistaxis, cheek hematoma and hypoesthesia of the palate	48 hours