An interventional study of Sphenopalatine ganglion block in Post-Dural Puncture Headache, sponsored by Brigham and Women's Hospital. Status unknown. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-28.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
This study aims to determine the efficacy of the sphenopalatine ganglion block in the treatment of post-dural puncture headache in post-partum women at the Brigham and Women's Hospital by measuring VAS scores at times between 0 and 24 hours after the block. We hypothesize that there will be at least a 50% reduction in VAS scores at 4 hours after performing the sphenopalatine block as compared to baseline VAS scores.
Post-dural puncture headache (PDPH) is a major cause of morbidity in postpartum patients who received neuraxial anesthesia for labor analgesia or cesarean delivery. The headache in PDPH is thought to be due to loss of cerebrospinal fluid causing downward traction on the meninges with parasympathetic ally mediated reflex vasodilation of the meningeal vessels. The epidural blood patch is currently the gold-standard treatment for postdural puncture headache, however it is an invasive procedure with possible risks and complications including bleeding, infection, pain, hematoma, neurologic complications, and repeat dural puncture. Patients are often offered conservative treatment including medications, bed rest, abdominal binders, and fluids for at least 24 hours prior to being offered an epidural blood patch. Once the decision is made to proceed with a blood patch, it may take several hours before the procedure is performed due to staffing issues. We propose that the sphenopalatine ganglion block, a relatively noninvasive procedure which has been used by neurologists as a treatment for a variety of types of headaches, may play a role in the treatment of postdural puncture headache in the obstetric population.The sphenopalatine ganglion is a parasympathetic ganglion located in the pterygopalatine fossa which can be accessed topically through the nose. The proposed mechanism of the sphenopalatine ganglion block is parasympathetic blockade preventing the profound vasodilation associated with the headache after a dural puncture, thus providing the patient with symptomatic relief. While the sphenopalatine ganglion block has been used by neurologists for the treatment of migraines and cluster headaches for years, little is known about its effectiveness in the treatment of post-dural puncture headache in post-partum women. A small case series by Kent et al demonstrated that offering the sphenopalatine ganglion block as a first-line treatment for post-dural puncture headache provided symptomatic relief and reduced the need for epidural blood patch. If the sphenopalatine ganglion block is found to be an effective treatment for post-dural puncture headache in the obstetric population, the block could be offered to patients as a firstline treatment as a way to improve VAS scores, reduce the need for medications with potential side effects, and possibly reduce the need for epidural blood patch.The primary outcome will be change in VAS scores at 4 hours after the sphenopalatine ganglion block. Secondary outcomes will include time to first Fioricet dose after the sphenopalatine ganglion block, presence of nausea at 4 hours, presence of neck pain at 4 hours, presence of visual changes at 4 hours, change in VAS scores at 12 hours, change in VAS scores at 24 hours, and need for epidural blood patch.
122 studies on the registry are indexed under Post-Dural Puncture Headache; 27 are open to participants now.
This study's planned enrollment of 20 is below the median of 80 across 79 interventional studies indexed under Post-Dural Puncture Headache.
Browse Post-Dural Puncture Headache studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Exclusion Criteria:
The patient will be placed supine, with head in sniffing position. Two long cotton-tipped applicators will be soaked in 4% lidocaine for 30 seconds. An anesthesia provider, after visually inspecting each nostril for any sign of deformity or blockage, will perform the block. A cotton tipped applicator will be inserted into one nostril at an angle perpendicular to the face, and will be advanced to the back of the nasopharynx until resistance is met. The procedure will be repeated in the other nostril. If the patient experiences any pain or discomfort, the physician will stop and redirect the applicator. The applicators will be left in place for 10 minutes, and then removed by the anesthesia provider.
Change in VAS scores for headache at 4 hours after the sphenopalatine ganglion block.
measured VAS for headache
Time frame: 4 h post-intervention
Time to first request of medication for symptom control after the sphenopalatine ganglion block,
Time frame: 24 h
Need for blood patch
performance of epidural blood patch for treatment of PDPH
Time frame: 24 h
Presence of nausea, neck pain, visual changes post-intervention
yes/no questions
Time frame: periodic questioning over 24h
Symptomatic relief of headache after the block
VAS scores at different time points via pain diaries
Time frame: 24 h
No study locations are listed for this record.
Plan to share: No — All data obtained during this study, both clinical and other data including pain diaries, will be kept confidential. Participants will be de-identified using codes so that the names of the study participants will be known only to the study investigators. No information about the identity of individual subjects will be used for publication. The pain diaries and consent forms will be kept in a locked file cabinet. All study data will be kept on a password-protected computer and only the research investigators will have access to the database.
Start is estimated for Jan 2018; primary completion for Dec 2018, 11 months later.
Of 33 non-industry interventional studies with no phase under Post-Dural Puncture Headache, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 32. This study's planned 11 months is above that.
Counting every sponsor, half of 34 studies reached it within 9 months; a quarter within 4 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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