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

NCT03652714 | Completed Phase 3 DMC

• 1 other identifier: GSPB-2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Postdural Puncture Headache; Sphenopalatine Ganglion Block

Outcome Measures

Primary Outcomes (1)

• 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.

  30 minutes after block

Secondary Outcomes (5)

• Pain rating (0-100mm on a visual analogue scale, VAS) in standing position

  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)

  30 minutes after block

• Number of patients needing "rescue GSP-block"

  During study period until completion of 1 week follow up

• Number of patients needing a epidural blood patch

  During study period until completion of 1 week follow up

• Pain rating (0-100mm on a visual analogue scale, VAS) in supine position

  30 minutes after block, 1 hour after block and 1 week after block

Study Arms (2)

Local anesthetic

EXPERIMENTAL

Procedure: Ganglion sphenopalatine block with local anesthetic

Isotonic NaCl

PLACEBO COMPARATOR

Procedure: Ganglion sphenopalatine block with placebo

Interventions

Ganglion sphenopalatine block with local anesthetic PROCEDURE

Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL.

Local anesthetic

Ganglion sphenopalatine block with placebo PROCEDURE

Block performed with bilaterally inserted q-tips with isotone NaCl

Isotonic NaCl

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (5)

Rigshospitalet, University of Copenhagen

Copenhagen, 2100, Denmark

Location

Bispebjerg and Frederiksberg Hospital, University of Copenhagen

Copenhagen, 2400, Denmark

Location

Rigshospitalet Glostrup, University of Copenhagen

Glostrup Municipality, 2600, Denmark

Location

Herlev Hospital, University of Copenhagen

Herlev, 2730, Denmark

Location

Nordsjællands Hospital Hillerød

Hillerød, 3400, Denmark

Location

Related Publications (1)

• 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.

  PMID: 32303377 DERIVED

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Sphenopalatine Ganglion Block; Anesthetics, Local

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; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 29, 2018
• Study Start: September 19, 2018
• Primary Completion: September 2, 2019
• Study Completion: September 9, 2019
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

DK (5)