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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sphenopalatine Ganglion Block, Adrenaline, Post-Dural Puncture Headache, Orthopedic, Randomized Controlled Study

Intervention / Treatment
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* Procedure: Sphenopalatine Ganglion Block
* Drug: Medical Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

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 |
| --- | --- |
| Active Comparator: Standard medical Treatment (paracetamol)<br>Patients will receive paracetamol 1 gm every 6 hours daily intravenously for a day. | Drug: Medical Treatment<br>* 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.<br>|
| Experimental: Sphenopalatine block<br>Patients will receive sphenopalatine block | Procedure: Sphenopalatine Ganglion Block<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of analgesia | The onset time till VAS≥ 4 | 48 hours | 
| Duration of analgesia | Duration with VAS< 4 | 48 hours | 
| Adverse events | Local anesthetic toxicity, hypertension, postoperative epistaxis, cheek hematoma and hypoesthesia of the palate | 48 hours |