An interventional study of Sphenopalatine ganglion block and Epidural blood patch in Post-Dural Puncture Headache, sponsored by Brasilia University Hospital. Terminated at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-28.
Sponsored by Brasilia University Hospital · Not applicable, Interventional, and Treatment
Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch for post dural puncture headache but the investigators do not know if it has significant efficacy when compared to epidural blood patch. Method: randomized trial where patients will randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain or low intensity pain will be the main outcome
Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch for post dural puncture headache but the investigators do not know if it has significant efficacy when compared to epidural blood patch. Method: randomized clinical trial where patients with moderate to severe post dural puncture pain will randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain or low intensity pain will be the main outcome. Pain recurrence, survival without pain and side effects (tinitus, low back pain, new dural puncture, sore throat) will be secondary outcomes.
122 studies on the registry are indexed under Post-Dural Puncture Headache; 27 are open to participants now.
This study's enrollment of 19 is below the median of 80 across 79 interventional studies indexed under Post-Dural Puncture Headache.
Browse Post-Dural Puncture Headache studies →Brasilia University Hospital is the lead sponsor of 20 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Patients will receive sphenopalatine ganglion block with ropivacaine 0.375% 3ml on each side
Procedure: Sphenopalatine ganglion block
Patients will receive classic epidural blood patch with 20ml of autologous blood
Procedure: Epidural blood patch
Cotton- tipped applicators inserted up through the nose followed by infusion of ligdocaine through the applicators.
Autologous sterile blood (20ml) will be infused in the lombar epidural space.
Pain relief
Pain assessed by categorical verbal scale (no pain, low pain, moderate pain or severe pain) 30 minutes after the procedure.
Time frame: Pain reduction to no pain or low pain within 30 minutes of the intervention.
Tinitus
Time frame: Incidence (dichotomic) of tinutus within 24 hours after the procedure.
Low back pain
Time frame: Incidence (dichotomic) of low back pain within 24 hours after the procedure.
Sore throat
Time frame: Incidence (dichotomic) of sore throat within 24 hours after the procedure.
Pain relief survival
Patients will be contacted for the first two weeks for monitoring new headache onsets.
Time frame: Incidence of new headache onset during the first two weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2016 to primary completion in Dec 2019, 36 months.
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This study is terminated, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Post-Dural Puncture Headache →
Brasilia University Hospital