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Clinical Trials/NCT04793490
NCT04793490
Completed
Not Applicable

Efficacy and Efficiency of Sphenopalatine Ganglion Block for Management of Post-dural Puncture Headache in Obstetric Patients-A Randomized Clinical Trial

Ain Shams University1 site in 1 country40 target enrollmentMarch 15, 2021

Overview

Phase
Not Applicable
Intervention
paracetamol
Conditions
Post-Dural Puncture Headache
Sponsor
Ain Shams University
Enrollment
40
Locations
1
Primary Endpoint
Numeric rating pain score
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 15, 2021
End Date
December 5, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marwa Mostafa Mohamed Ali Mowafi

Lecturer of anesthesia ,principal Investigator

Ain Shams University

Eligibility Criteria

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

Arms & Interventions

Group A (Control group)

Patients will receive paracetamol 1 g thrice daily intravenously

Intervention: paracetamol

Group B (Sphenopalatine ganglion block group)

patients will receive sphenopalatine ganglion block via transnasal approache by a cotton tipped applicator soaked in 2%lignocaine with 4 mg dexamethasone

Intervention: Sphenopalatine ganglion block

Outcomes

Primary Outcomes

Numeric rating pain score

Time Frame: First 24 hours after the procedure

Numeric rating pain score will be used to assess the efficacy of SPGB for treatment of PDPH

Secondary Outcomes

  • Total analgesic consumption(First 24 hours after the procedure)

Study Sites (1)

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