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

Primary Purpose

Postdural Puncture Headache, Sphenopalatine Ganglion Block

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Ganglion sphenopalatine block with local anesthetic
Ganglion sphenopalatine block with placebo
Sponsored by
University Hospital Bispebjerg and Frederiksberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postdural Puncture Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rigshospitalet, University of Copenhagen
  • Bispebjerg and Frederiksberg Hospital, University of Copenhagen
  • Rigshospitalet Glostrup, University of Copenhagen
  • Herlev Hospital, University of Copenhagen
  • Nordsjællands Hospital Hillerød

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Local anesthetic

Isotonic NaCl

Arm Description

Outcomes

Primary Outcome Measures

Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position.
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.

Secondary Outcome Measures

Pain rating (0-100mm on a visual analogue scale, VAS) in standing position
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.
Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS)
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.
Number of patients needing "rescue GSP-block"
Number of patients needing a epidural blood patch
Pain rating (0-100mm on a visual analogue scale, VAS) in supine position

Full Information

First Posted
August 27, 2018
Last Updated
September 10, 2019
Sponsor
University Hospital Bispebjerg and Frederiksberg
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1. Study Identification

Unique Protocol Identification Number
NCT03652714
Brief Title
The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache
Official Title
The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache: a Blinded Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 19, 2018 (Actual)
Primary Completion Date
September 2, 2019 (Actual)
Study Completion Date
September 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Bispebjerg and Frederiksberg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postdural Puncture Headache, Sphenopalatine Ganglion Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local anesthetic
Arm Type
Experimental
Arm Title
Isotonic NaCl
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Ganglion sphenopalatine block with local anesthetic
Intervention Description
Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL.
Intervention Type
Procedure
Intervention Name(s)
Ganglion sphenopalatine block with placebo
Intervention Description
Block performed with bilaterally inserted q-tips with isotone NaCl
Primary Outcome Measure Information:
Title
Hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position.
Description
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.
Time Frame
30 minutes after block
Secondary Outcome Measure Information:
Title
Pain rating (0-100mm on a visual analogue scale, VAS) in standing position
Description
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.
Time Frame
1 hour after block and 1 week after block
Title
Number of patients with pain rating below 30mm in standing position (0-100mm on a visual analogue scale, VAS)
Description
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.
Time Frame
30 minutes after block
Title
Number of patients needing "rescue GSP-block"
Time Frame
During study period until completion of 1 week follow up
Title
Number of patients needing a epidural blood patch
Time Frame
During study period until completion of 1 week follow up
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rigshospitalet, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Bispebjerg and Frederiksberg Hospital, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Rigshospitalet Glostrup, University of Copenhagen
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Herlev Hospital, University of Copenhagen
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Nordsjællands Hospital Hillerød
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
32303377
Citation
Jespersen MS, Jaeger P, AEgidius KL, Fabritius ML, Duch P, Rye I, Afshari A, Meyhoff CS. Sphenopalatine ganglion block for the treatment of postdural puncture headache: a randomised, blinded, clinical trial. Br J Anaesth. 2020 Jun;124(6):739-747. doi: 10.1016/j.bja.2020.02.025. Epub 2020 Apr 15.
Results Reference
derived

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

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