Sphenopalatine Ganglion Block for Management of Post- Dural Puncture Headache in Obstetric Patients

Not Applicable

Completed

• Conditions: Post-Dural Puncture Headache
• Interventions: Drug: paracetamol; Procedure: Sphenopalatine ganglion block

• Registration Number: NCT04793490
• Lead Sponsor: Ain Shams University

Brief Summary

The purpose of this trial is to study the efficacy and efficiency of sphenopalatine ganglion block for management of post dural puncture headache in obstetric patients

Detailed Description

Background and objectives: Post dural puncture headache(PDPH) is a common complication of lumbar puncture, it is likely due to the loss of cerebrospinal fluid into the epidural space through the dural tear. The prevalence of PDPH is higher in pregnant women.Sphenopalatine ganglion block (SPGB) is a non-invasive intervention with minimal adverse effects, it is indicated in acute and chronic facial/head pain like cluster headache, trigeminal neuralgia, post herpetic neuralgia and pain due to head and neck cancer.SPGB can be performed by different approaches:transnasal,transoral ,sub zygomatic and lateral infratemporal.Transnasal is the easiest, least invasive approach which can be done at bedside.

The objective of this trial is to study the efficacy and efficiency of sphenopalatine ganglion block for management of post-dural puncture headache in obstetric patients.The following will be recorded: pain score will be assessed using the numeric rating pain scale(NRS),heart rate and mean arterial pressure, onset and duration of analgesia, total dose of ketorolac, duration of hospital stay and patient satisfaction

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-06
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-11
• Study Start: 2021-03-15
• Primary Completion: 2021-11-25
• Study Completion: 2021-12-05
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Female patients ASA I or II post caesarean section
• Body weight between 60-100 kg
• Active PDPH within days after spinal anesthesia not relieved with standard treatment such as, intravenous fluids, bed rest and caffeine.

Exclusion Criteria

• Patient refusal to participate in the study
• Body mass index >35kg/m2
• Patients with :coagulopathy ,nasal septal deviation,polyp
• History of nasal bleeding
• Allergy to local anesthetic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (Control group)	paracetamol	Patients will receive paracetamol 1 g thrice daily intravenously
Group B (Sphenopalatine ganglion block group)	Sphenopalatine ganglion block	patients will receive sphenopalatine ganglion block via transnasal approache by a cotton tipped applicator soaked in 2%lignocaine with 4 mg dexamethasone

Primary Outcome Measures

Name	Time	Method
Numeric rating pain score	First 24 hours after the procedure	Numeric rating pain score will be used to assess the efficacy of SPGB for treatment of PDPH

Secondary Outcome Measures

Name	Time	Method
Total analgesic consumption	First 24 hours after the procedure	total dose of ketorolac will be calculated

Trial Locations

Locations (1)

Ain Shams University Hospital; 🇪🇬 Cairo, Abassia, Egypt