The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache

September 10, 2019 updated by: Mads Seit Jespersen, University Hospital Bispebjerg and Frederiksberg

The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache: a Blinded Randomized Clinical Trial

The purpose of this study is to evaluate the effect of the ganglion sphenopalatine block (GSP block) on postdural puncture headache.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adult patients with postdural puncture headache will be enrolled in the study. The patients will be randomised to receive a ganglion sphenopalatine block (GSP-block) with either local anesthetic (lidocaine + ropivacaine) or placebo (isotone NaCl).

Primary outcome is hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position 30 minutes after block.

If the patients in the timeframe of 1 hour to 1 week after block does not achieve remission (VAS <30mm while standing) they will be offered a "rescue GSP-block" defined as a new GSP-block with "open-label" local anesthetic and if continued lack of remission at least 1 hour thereafter then an epidural blood patch will be offered.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Bispebjerg and Frederiksberg Hospital, University of Copenhagen
      • Copenhagen, Denmark, 2100
        • Rigshospitalet, University of Copenhagen
      • Glostrup, Denmark, 2600
        • Rigshospitalet Glostrup, University of Copenhagen
      • Herlev, Denmark, 2730
        • Herlev Hospital, University of Copenhagen
      • Hillerød, Denmark, 3400
        • Nordsjællands Hospital Hillerød

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years
  • Patients with postdural puncture headache defined as moderate to severe postural headache (VAS >= 30mm) after lumbar puncture or accidental dural puncture during epidural insertion with an onset within 3 days following the puncture.
  • Lack of headache remission within 1 day after dural puncture and after treatment with fluids, caffeine and paracetamol
  • Patients who have given their written informed consent for participation in the study after fully understanding the protocol content and limitations.

Exclusion Criteria:

  • Patients who cannot cooperate to the study
  • Patients who does not understand or speak Danish
  • Allergy to the drugs used in the study
  • Has taken opioids within 12 hours prior to intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Local anesthetic
Procedure: Ganglion sphenopalatine block with local anesthetic
Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL.
PLACEBO_COMPARATOR: Isotonic NaCl
Procedure: Ganglion sphenopalatine block with placebo
Block performed with bilaterally inserted q-tips with isotone NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position.
Time Frame: 30 minutes after block
Pain intensity will be measured as worst experienced pain after the patient has been standing for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted.
30 minutes after block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain rating (0-100mm on a visual analogue scale, VAS) in standing position
Time Frame: 1 hour after block and 1 week after block
Pain intensity measured as worst experienced pain after the patient has been standing for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted.
1 hour after block and 1 week after block
Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS)
Time Frame: 30 minutes after block
Pain intensity measured as worst experienced pain after the patient has been standing for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted.
30 minutes after block
Number of patients needing "rescue GSP-block"
Time Frame: During study period until completion of 1 week follow up
During study period until completion of 1 week follow up
Number of patients needing a epidural blood patch
Time Frame: During study period until completion of 1 week follow up
During study period until completion of 1 week follow up
Pain rating (0-100mm on a visual analogue scale, VAS) in supine position
Time Frame: 30 minutes after block, 1 hour after block and 1 week after block
30 minutes after block, 1 hour after block and 1 week after block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Bispebjerg and Frederiksberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 19, 2018

Primary Completion (ACTUAL)

September 2, 2019

Study Completion (ACTUAL)

September 9, 2019

Study Registration Dates

First Submitted

August 27, 2018

First Submitted That Met QC Criteria

August 28, 2018

First Posted (ACTUAL)

August 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GSPB-2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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