Sphenopalatine Ganglion Block for Postdural Puncture Headache in the Emergency Department

NCT02517931 | Withdrawn DMC

• 1 other identifier: 204502
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates sphenopalatine ganglion block (SPGB) for the treatment of postdural puncture headache (PDPH) in the emergency department (ED). Half of the patients will receive a true nerve block with lidocaine and bupivacaine. The other half will receive a placebo nerve block.

Conditions

Postdural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• Pain level with Verbal Rating Scale

  Patients will be asked to self rate their pain with 0 as no pain at all up to 10 being the worst pain imaginable.

  5 days

Study Arms (2)

Sphenopalatine Ganglion Block

ACTIVE COMPARATOR

Subjects will be asked to blow out each nostril. They will then be laid supine with a small shoulder roll and intranasal phenylephrine 0.25% (RhinallⓇ) will be sprayed once into each nostril to preemptively minimize bleeding. Sphenopalatine ganglion block will be performed by inserting long cotton tipped applicators saturated in 2% viscous lidocaine into nostril until properly seated in the posterior nasopharynx. These will be left in place for 10 minutes and then 1 mililiter of 0.5% bupivacaine will be administered down the plastic hollow shaft of each applicator via an 18g angiocatheter. The applicators will remain in place for 10 more minutes and then be removed.

Procedure: Sphenopalatine Ganglion Block

Placebo

PLACEBO COMPARATOR

Subjects will be asked to blow out each nostril. They will then be laid supine with a small shoulder roll and intranasal phenylephrine 0.25% (RhinallⓇ) will be sprayed once into each nostril to preemptively minimize bleeding. SPGB will be performed by inserting long cotton tipped applicators saturated in carboxymethylcellulose based lubricant (i.e. K-Y Jelly®) into nostril until properly seated in the posterior nasopharynx. These will be left in place for 10 minutes and then 1 mililiter of normal saline will be administered down the plastic hollow shaft of each applicator via an 18g angiocatheter. The applicators will remain in place for 10 more minutes and then be removed.

Procedure: Placebo

Interventions

Sphenopalatine Ganglion Block PROCEDURE

Subjects will be asked to blow out each nostril. They will then be laid supine with a small shoulder roll and intranasal phenylephrine 0.25% (RhinallⓇ) will be sprayed once into each nostril to preemptively minimize bleeding. SPGB will be performed by inserting long cotton tipped applicators saturated in 2% viscous lidocaine into nostril until properly seated in the posterior nasopharynx. These will be left in place for 10 minutes and then 1mL of 0.5% bupivacaine will be administered down the plastic hollow shaft of each applicator via an 18g angiocatheter. The applicators will remain in place for 10 more minutes and then be removed.

Sphenopalatine Ganglion Block

Placebo PROCEDURE

Subjects will be asked to blow out each nostril. They will then be laid supine with a small shoulder roll and intranasal phenylephrine 0.25% (RhinallⓇ) will be sprayed once into each nostril to preemptively minimize bleeding. SPGB will be performed by inserting long cotton tipped applicators saturated in carboxymethylcellulose based lubricant (i.e. K-Y Jelly®) into nostril until properly seated in the posterior nasopharynx. These will be left in place for 10 minutes and then 1 mililiter of normal saline will be administered down the plastic hollow shaft of each applicator via an 18g angiocatheter. The applicators will remain in place for 10 more minutes and then be removed.

Placebo

Eligibility Criteria

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

You may qualify if:

• Active postdural puncture headache within 7 days after diagnostic lumbar puncture
• Age ≥ 18 years.
• American Society of Anesthesiologists (ASA) physical status ≤ 3

You may not qualify if:

• Known coagulopathy
• Known nasal septal deviation or abnormalities
• Medical conditions contraindicated to lidocaine or bupivacaine

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72202, United States

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 Officials

• Carly Eastin, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 7, 2015
• Study Start: January 1, 2019
• Primary Completion: September 23, 2019
• Study Completion: September 23, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

US (1)