Sphenopalatine Block or Epidural Bloodpatch for Post Dural Puncture Headache: Randomized Controlled Trial

NCT02984618 | Terminated

• 1 other identifier: CAAE: 60693416.0.0000.5558
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-Dural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• Pain relief

  Pain assessed by categorical verbal scale (no pain, low pain, moderate pain or severe pain) 30 minutes after the procedure.

  Pain reduction to no pain or low pain within 30 minutes of the intervention.

Secondary Outcomes (3)

• Tinitus

  Incidence (dichotomic) of tinutus within 24 hours after the procedure.

• Low back pain

  Incidence (dichotomic) of low back pain within 24 hours after the procedure.

• Sore throat

  Incidence (dichotomic) of sore throat within 24 hours after the procedure.

Other Outcomes (1)

• Pain relief survival

  Incidence of new headache onset during the first two weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

Patients will receive sphenopalatine ganglion block with ropivacaine 0.375% 3ml on each side

Procedure: Sphenopalatine ganglion block

Control group

ACTIVE COMPARATOR

Patients will receive classic epidural blood patch with 20ml of autologous blood

Procedure: Epidural blood patch

Interventions

Sphenopalatine ganglion block PROCEDURE

Cotton- tipped applicators inserted up through the nose followed by infusion of ligdocaine through the applicators.

Treatment group

Epidural blood patch PROCEDURE

Autologous sterile blood (20ml) will be infused in the lombar epidural space.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnostic criteria for post dural puncture headache
• Moderate to severe post dural puncture headache

You may not qualify if:

• Procedure failures: new dural puncture on epidural blood patch trial, unable to find epidural space, intolerance to insertion of nasal swabs.
• Follow up loss

Sponsors & Collaborators

• Brasilia University Hospital: lead

Study Sites (1)

Hospital Universitário de Brasilia

Brasília, Federal District, 70000000, Brazil

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Sphenopalatine Ganglion Block; Blood Patch, Epidural

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Autonomic Nerve Block; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Biological Therapy; Therapeutics; Injections, Epidural; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy

Study Officials

• Gabriel MN Guimaraes, MsC, MD

  Universidade de Brasilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Substitute professor of Anesthesiology

Study Record Dates

• First Submitted: December 3, 2016
• First Posted: December 7, 2016
• Study Start: December 1, 2016
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)