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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2019-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sphenopalatine Ganglion Block for Postdural Puncture Headache

NCT04892290

Postdural Puncture Headache

COMPLETED

Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

NCT02181205

Postdural Puncture Headache Sphenopalatine Ganglion Block

WITHDRAWN NA

Trans-nasal Sphenopalatine Ganglion Block Versus Ultrasound-guided Bilateral Greater and Lesser Occipital Nerve Block for Management of Post-Dural Puncture Headache.

NCT06705244

Post-Dural Puncture Headache

ACTIVE_NOT_RECRUITING NA

Bilateral Sphenopalatine Ganglion Block With or Without Bilateral Greater Occipital Nerve Block for Treatment of Obstetric Post-Dural Puncture Headache

NCT04844229

Post-Dural Puncture Headache

COMPLETED NA

Sphenopalatine Ganglion Block Versus Occiptal Nerve Block in Treatment of Post Dural Puncture Headache

NCT03156049

Headache

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-Dural Puncture Headache

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment group

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

Group Type EXPERIMENTAL

Sphenopalatine ganglion block

Intervention Type PROCEDURE

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

Control group

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

Group Type ACTIVE_COMPARATOR

Epidural blood patch

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sphenopalatine ganglion block

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

Intervention Type PROCEDURE

Epidural blood patch

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No