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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Post-Dural Puncture Headache

Intervention / Treatment
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* Procedure: Sphenopalatine ganglion block
* Drug: paracetamol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A (Control group)<br>Patients will receive paracetamol 1 g thrice daily intravenously | Drug: paracetamol<br>* patients will receive paracetamol 1 g thrice daily intravenously<br>* Other names: acetaminophen;|
| Active Comparator: Group B (Sphenopalatine ganglion block group)<br>patients will receive sphenopalatine ganglion block via transnasal approache by a cotton tipped applicator soaked in 2%lignocaine with 4 mg dexamethasone | Procedure: Sphenopalatine ganglion block<br>* Patients will receive the SPGB via the transnasal approache by a cotton tipped applicator soaked in lignocaine 2% with 4 mg dexamethasone<br>* Other names: SPGB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating pain score | Numeric rating pain score will be used to assess the efficacy of SPGB for treatment of PDPH | First 24 hours after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total analgesic consumption | total dose of ketorolac will be calculated | First 24 hours after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sphenopalatine ganglion block, Post-Dural Puncture Headache