Effectiveness of Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

NCT03430531 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 8426
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to determine the effectiveness of Spheno-Palatine (SP) ganglion block to alleviate the pain of post-dural puncture headache (PDPH).

Conditions

Post-Dural Puncture Headache; Sphenopalatine Ganglion Block

Outcome Measures

Primary Outcomes (6)

• Pain Score at Baseline

  Pain scores will be recorded at Baseline in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.

  15 minutes before the SP block

• Pain Score 60 Minutes Post-SP Block

  Pain scores will be recorded 60 minutes post-SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.

  60 minutes

• Pain Score 1 Day Post-SP Block

  Patient reported pain scores will be recorded day 1 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.

  1 day

• Pain Score 2 Days Post-SP Block

  Patient reported pain scores will be recorded day 2 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.

  2 days

• Pain Score 7 Days Post-SP Block

  Patient reported pain scores will be recorded day 7 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.

  7 days

• Pain Score 30 Day Post-SP Block

  Patient reported pain scores will be recorded day 30 post SP block in a sitting position. Pain scores will be quantified using the Visual analog pain (VAS) scale. The visual analog scale (VAS) is a tool widely used to measure pain. The scale range is 0-10 with 0 being no pain and 10 being severe pain.

  30 days

Secondary Outcomes (3)

• Duration of Pain Relief

  24 hours

• Number of Participants With Recurrence of Post-dural Puncture Headache

  7 days

• Number of Participants With Complications Due to SP Ganglion Block

  15 minutes before the SP block to 30 days post SP block

Study Arms (1)

Sphenopalatine ganglion block

EXPERIMENTAL

Sphenopalatine ganglion block: this block will be performed by inserting swabs, with lidocaine squirted on them, into each nostril and reaching the nasopharyngeal wall.

Drug: Lidocaine

Interventions

Lidocaine DRUG

Lidocaine 2% viscous (0.5ml) will be squirted on two cotton swab sticks and one will be gently inserted into each nostril, along the floor of the nose. Slight rotatory motion of the stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab sticks will be left undisturbed for 5 minutes. The swabs will be taken out and this will be repeated twice more, using fresh swabs and 0.5ml of 2% lidocaine. The block would take about 30 minutes.

Sphenopalatine ganglion block

Eligibility Criteria

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

You may qualify if:

• Complains of symptoms suggestive of post-dural puncture headache
• Has a history of dural puncture (lumbar puncture or accidental dural puncture during epidural placement) within the previous 7 days
• Fluent in written and spoken English

You may not qualify if:

• Those with a known history of hypersensitivity to local anesthetics of the amide type or to other components of GLYDO
• Those with any congenital or acquired, anatomical deformity of the nostril, which preclude performing the block
• Those who refuse to consent to participate in the study
• Patients who have had a failed epidural blood patch
• Cognitive Impairment
• Prisoner

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

The target enrollment was not reached secondary to the COVID-19 pandemic.

Results Point of Contact

• Title: Dr. Verghese Cherian
• Organization: Penn State Hershey Medical Center

vcherian@pennstatehealth.psu.edu

7175318521

Study Officials

• Verghese Cherian, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology & Perioperative Medicine

Model Details: Open-label, single arm, pilot study

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 13, 2018
• Study Start: May 31, 2019
• Primary Completion: January 16, 2020
• Study Completion: March 11, 2022
• Last Updated: June 15, 2022
• Results First Posted: June 15, 2022

Record last verified: 2022-05

Locations

US (1)