An interventional study of bupivacaine and placebo in Postdural Puncture Headache and Sphenopalatine Ganglion Block, sponsored by Wake Forest University Health Sciences. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-11-08.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
The investigators are attempting to determine a less invasive method of treatment for postdural puncture headaches that can occur after regional anesthesia. The investigators will be evaluating the relief of headache with those subjects receiving treatment with a sphenopalatine ganglion block with bupivacaine versus placebo, evaluating the incidence of epidural blood patch, pain score of headache at 1 hour, then 24, 48, and 72 hours lower with post study treatment versus placebo, and potential side effects of those patients receiving study therapy as well as epidural blood patch.
136 studies on the registry are indexed under Ganglion Cysts; 28 are open to participants now.
Browse Ganglion Cysts studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
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Exclusion Criteria:
sphenopalatine ganglion block performed with normal saline as the placebo
Drug: placebo
sphenopalatine ganglion block performed with bupivacaine
Drug: bupivacaine
verbal pain score
a reduction in headache verbal pain score by 3
Time frame: 1 hour
epidural blood patch
evaluating the decrease in the necessity of an epidural blood patch to treat the postdural puncture headache
Time frame: 7 days
patient satisfaction
patient satisfaction with headache pain relief at 1 hour post treatment
Time frame: 1 hour
pain score
verbal pain score 30 minutes post study treatment
Time frame: 30 minutes
pain score
verbal pain score 7 days post study treatment
Time frame: 7 days
This study is withdrawn, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences