Changes in Cerebral Blood Flow (CBF) in Prone and Sitting Position Before and After GSP-block and Before and After Epidural Blood-patch: A Substudy of NCT03652714

NCT03966547 | Withdrawn DMC

• 1 other identifier: GSPB-2018-SUB
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this optional sub-study to GSPB-2018 (NCT03652714) is to evaluate the changes in cerebral blood flow (CBF) under different conditions to understand if postdural puncture headache is caused by changes in the cerebral blood flow and if treatment normalises that change.

Conditions

Postdural Puncture Headache; Sphenopalatine Ganglion Block

Outcome Measures

Primary Outcomes (2)

• Change in Cerebral Blood Flow velcity (CBF) in supine versus upright position compared to effect of treatment.

  Change in mean, minimum and maximum Cerebral Blood Flow velcity in cm/sec (CBF) in supine versus upright position compared to effect of treatment.

  <1h before and 1 hour after each intervention

• Comparison of paint rating (0-100 on a visual analogue scale, VAS) and Cerebral Blood Flow velocity (CBF) before and after each intervention.

  Pain intensity measured with a pain rating (0-100mm on a visual analogue scale, VAS) in supine position and as worst experienced pain after the patient has been upright for 30 seconds or the worst experienced pain while attempting to stand if the rating has to be interrupted. Cerebral Blood Flow velocity (CBF) measured as mean blood flow in cm/sec.

  <1h before and 1 hour after each intervention

Secondary Outcomes (1)

• Change in Cerebral Blood Flow velocity (CBF) in supine position before and after interventions.

  <1h before and 1 hour after each intervention

Study Arms (2)

Local anesthetic

EXPERIMENTAL

Procedure: Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018

Isotonic NaCl

PLACEBO COMPARATOR

Procedure: Ganglion sphenopalatine block with placebo administered on study GSPB-2018

Interventions

Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018 PROCEDURE

Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL as per GSPB-2018.

Local anesthetic

Ganglion sphenopalatine block with placebo administered on study GSPB-2018 PROCEDURE

Block performed with bilaterally inserted q-tips with isotone NaCl as per GSPB-2018.

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 and substudy 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
• No possible transcranial window on transcranial doppler. If not possible to find a useable window to get measurement the patient will be excluded and replaced with another patient.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (2)

Bispebjerg and Frederiksberg Hospital, University of Copenhagen

Copenhagen, 2400, Denmark

Location

Rigshospitalet, University of Copenhagen

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Sphenopalatine Ganglion Block

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Primary Investigator

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 29, 2019
• Study Start: May 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

DK (2)