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Completed

NCT Number: NCT04793490

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

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

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Key information

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospital

Cairo, Abassia, 11591, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sphenopalatine Ganglion Block

Procedure

Patients will receive the SPGB via the transnasal approache by a cotton tipped applicator soaked in lignocaine 2% with 4 mg dexamethasone

Other names: SPGB

Paracetamol

Drug

patients will receive paracetamol 1 g thrice daily intravenously

Other names: acetaminophen

Primary outcomes

  1. 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

  1. Total analgesic consumption

    Time frame: First 24 hours after the procedure

    total dose of ketorolac will be calculated

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 11, 2021
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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