RCT of SPG Blocks for Post-dural Headache

NCT03560349 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 110257
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the effectiveness of the SPG block with lidocaine vs. SPG block with placebo on preventing the need for EBP in women who develop PDPH after accidental dural puncture during placement of LEA for labor.

Conditions

Post-Dural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• Epidural Blood Patch

  Proportion of postpartum women with a postdural puncture headache (PDPH) requesting epidural blood patch (EBP)

  7 days after treatment with lidocaine or placebo block

Secondary Outcomes (2)

• Verbal Numerical Pain

  30 minutes, 1 hour, 2, hour, 1 day, 2, days, 3 days, 4 days, 5 days, 6 days, and 7 days after treatment with lidocaine or placebo block

• Verbal Functionality Score

  1 day, 2, days, 3 days, 4 days, 5 days, 6 days, and 7 days after treatment with lidocaine or placebo block

Study Arms (2)

Lidocaine

EXPERIMENTAL

Transnasal blockade of SPG approach involving the application of 2 cc (approximately the size of a pea) of 2% lidocaine jelly on a cotton swab directed posteriorly towards the SPG in the nasal passage bilaterally. Cotton swab will be inserted to the back of the nasal passage until it can no longer be inserted any further. The cotton swab should remain in place for 15 minutes on both sides simultaneously. The patient will be instructed on how to perform this procedure on themselves, and they will be given supplies for a 7-day supply of medication to be administered two times per day at approximately 12 hour intervals.

Drug: Lidocaine HCl Gel 2%

Placebo

PLACEBO COMPARATOR

Transnasal blockade of SPG approach involving the application of 2 cc (approximately the size of a pea) of nasal saline jelly on a cotton swab directed posteriorly towards the SPG in the nasal passage bilaterally. Cotton swab will be inserted to the back of the nasal passage until it can no longer be inserted any further. The cotton swab should remain in place for 15 minutes. The patient will be instructed on how to perform this procedure on themselves, and they will be given supplies for a 7-day supply of medication to be administered up to two times per day at approximately 12 hour intervals.

Drug: placebo gel

Interventions

Lidocaine HCl Gel 2% DRUG

Patients will be prescribed a regimen of 1 g acetaminophen q 8hrs alternating with 600 mg ibuprofen q 6 hours. In addition they will be instructed to continue oral fluid hydration and minimal activity for 24 hours. At 2-hours following the SPG blockade an EBP will be offered to patients. Patient will also be informed that they can request an EBP at any time. The SPG blockade will be performed twice daily in the hospital and twice daily at home, by the patient. The patient will also be informed, if that at anytime, they would like an EBP, it can be provided. While the study is being conducted, patients will not be offered a SPG block unless enrolled in the study.

Lidocaine

placebo gel DRUG

Patients will be prescribed a regimen of 1 g acetaminophen q 8hrs alternating with 600 mg ibuprofen q 6 hours. In addition they will be instructed to continue oral fluid hydration and minimal activity for 24 hours. At 2-hours following the SPG blockade an EBP will be offered to patients. Patient will also be informed that they can request an EBP at any time. The SPG blockade will be performed twice daily in the hospital and twice daily at home, by the patient. The patient will also be informed, if that at anytime, they would like an EBP, it can be provided. While the study is being conducted, patients will not be offered a SPG block unless enrolled in the study.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Studying post partum women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females
• age 18-50
• Post Dural Puncture Headache after documented accidental dural puncture during placement of LEA for labor and no better explanation for headache
• onset of HA within 72 hours of delivery.

You may not qualify if:

• true allergy to local anesthesia
• Hereditary Hemorrhagic Telangiectasia
• inability to understand pain scores and other questionnaires
• inability to speak English
• contraindication to acetaminophen or NSAIDs
• temperature \>38.5 C
• prior Epidural Blood Patch done for this headache

Sponsors & Collaborators

• University of Utah: lead
• University of Colorado, Denver: collaborator
• University of California, San Francisco: collaborator
• Duke University: collaborator
• Mayo Clinic: collaborator
• Harvard University: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (13)

• Turnbull DK, Shepherd DB. Post-dural puncture headache: pathogenesis, prevention and treatment. Br J Anaesth. 2003 Nov;91(5):718-29. doi: 10.1093/bja/aeg231.

  PMID: 14570796 BACKGROUND

• Amorim JA, Gomes de Barros MV, Valenca MM. Post-dural (post-lumbar) puncture headache: risk factors and clinical features. Cephalalgia. 2012 Sep;32(12):916-23. doi: 10.1177/0333102412453951. Epub 2012 Jul 27.

  PMID: 22843225 BACKGROUND

• Flaatten H, Rodt S, Rosland J, Vamnes J. Postoperative headache in young patients after spinal anaesthesia. Anaesthesia. 1987 Feb;42(2):202-5. doi: 10.1111/j.1365-2044.1987.tb03001.x.

  PMID: 3826597 BACKGROUND

• Abouleish E, Vega S, Blendinger I, Tio TO. Long-term follow-up of epidural blood patch. Anesth Analg. 1975 Jul-Aug;54(4):459-63. doi: 10.1213/00000539-197554040-00012.

  PMID: 125053 BACKGROUND

• Cornwall RD, Dolan WM. Radicular back pain following lumbar epidural blood patch. Anesthesiology. 1975 Dec;43(6):692-3. doi: 10.1097/00000542-197512000-00023. No abstract available.

  PMID: 127535 BACKGROUND

• Mehta SP, Keogh BP, Lam AM. An epidural blood patch causing acute neurologic dysfunction necessitating a decompressive laminectomy. Reg Anesth Pain Med. 2014 Jan-Feb;39(1):78-80. doi: 10.1097/AAP.0000000000000025.

  PMID: 24310044 BACKGROUND

• Reynolds AF Jr, Hameroff SR, Blitt CD, Roberts WL. Spinal subdural epiarachnoid hematoma: a complication of a novel epidural blood patch technique. Anesth Analg. 1980 Sep;59(9):702-3. No abstract available.

  PMID: 7191232 BACKGROUND

• Sperry RJ, Gartrell A, Johnson JO. Epidural blood patch can cause acute neurologic deterioration. Anesthesiology. 1995 Jan;82(1):303-5. doi: 10.1097/00000542-199501000-00038. No abstract available.

  PMID: 7832316 BACKGROUND

• Nair AS, Rayani BK. Sphenopalatine ganglion block for relieving postdural puncture headache: technique and mechanism of action of block with a narrative review of efficacy. Korean J Pain. 2017 Apr;30(2):93-97. doi: 10.3344/kjp.2017.30.2.93. Epub 2017 Mar 31.

  PMID: 28416992 BACKGROUND

• Kent S, Mehaffey G. Transnasal sphenopalatine ganglion block for the treatment of postdural puncture headache in obstetric patients. J Clin Anesth. 2016 Nov;34:194-6. doi: 10.1016/j.jclinane.2016.04.009. Epub 2016 May 11.

  PMID: 27687372 BACKGROUND

• Kent S, Mehaffey G. Transnasal sphenopalatine ganglion block for the treatment of postdural puncture headache in the ED. Am J Emerg Med. 2015 Nov;33(11):1714.e1-2. doi: 10.1016/j.ajem.2015.03.024. Epub 2015 Mar 14. No abstract available.

  PMID: 25819208 BACKGROUND

• Cohen S, Ramos D, Grubb W, Mellender S, Mohiuddin A, Chiricolo A. Sphenopalatine ganglion block: a safer alternative to epidural blood patch for postdural puncture headache. Reg Anesth Pain Med. 2014 Nov-Dec;39(6):563. doi: 10.1097/AAP.0000000000000172. No abstract available.

  PMID: 25340493 BACKGROUND

• Schaffer JT, Hunter BR, Ball KM, Weaver CS. Noninvasive sphenopalatine ganglion block for acute headache in the emergency department: a randomized placebo-controlled trial. Ann Emerg Med. 2015 May;65(5):503-10. doi: 10.1016/j.annemergmed.2014.12.012. Epub 2015 Jan 7.

  PMID: 25577713 BACKGROUND

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 18, 2018
• Study Start: July 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

US (1)