A Phase 4 interventional study of Sphenopalatine Ganglion Block and Medical Treatment in Sphenopalatine Ganglion Block, Adrenaline and Post-Dural Puncture Headache, sponsored by Tanta University. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-12-08.
Sponsored by Tanta University · Phase 4, Interventional, and Treatment
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.
136 studies on the registry are indexed under Ganglion Cysts; 28 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 101 interventional studies indexed under Ganglion Cysts.
Browse Ganglion Cysts studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients will receive paracetamol 1 gm every 6 hours daily intravenously for a day.
Drug: Medical Treatment
Patients will receive sphenopalatine block
Procedure: Sphenopalatine Ganglion Block
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.
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.
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
Time frame: 48 hours
Onset of analgesia
The onset time till VAS≥ 4
Time frame: 48 hours
Duration of analgesia
Duration with VAS\< 4
Time frame: 48 hours
Adverse events
Local anesthetic toxicity, hypertension, postoperative epistaxis, cheek hematoma and hypoesthesia of the palate
Time frame: 48 hours
No study locations are listed for this record.
Plan to share: Yes — The data will be available upon reasonable request
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Tanta University