Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

Sphenopalatine Ganglion Block for Treatment of Postdural Puncture Headache: A Prospective Randomized Double Blind Placebo Controlled Study

The investigators are attempting to determine a less invasive method of treatment for postdural puncture headaches that can occur after regional anesthesia. The investigators will be evaluating the relief of headache with those subjects receiving treatment with a sphenopalatine ganglion block with bupivacaine versus placebo, evaluating the incidence of epidural blood patch, pain score of headache at 1 hour, then 24, 48, and 72 hours lower with post study treatment versus placebo, and potential side effects of those patients receiving study therapy as well as epidural blood patch.

Study Overview

• Status: Withdrawn
• Conditions: Postdural Puncture Headache; Sphenopalatine Ganglion Block
• Intervention / Treatment: Drug: placebo; Drug: bupivacaine

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Forsyth Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• American Society of Anesthesiologists assigned class I-III
• age >/= 18 years
• experiencing a postdural puncture headache within 7 days of neuraxial analgesia rated >3/10 pain score

Exclusion Criteria:

• allergy to study medications <18 years of age pain score on presentation </=3/10 for headache

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: placebo; sphenopalatine ganglion block performed with normal saline as the placebo	Drug: placebo
Active Comparator: bupivacaine; sphenopalatine ganglion block performed with bupivacaine	Drug: bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
verbal pain score	a reduction in headache verbal pain score by 3	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
epidural blood patch	evaluating the decrease in the necessity of an epidural blood patch to treat the postdural puncture headache	7 days
patient satisfaction	patient satisfaction with headache pain relief at 1 hour post treatment	1 hour
pain score	verbal pain score 30 minutes post study treatment	30 minutes
pain score	verbal pain score 7 days post study treatment	7 days

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Peter H Pan, MD, MSEE, Wake Forest School of Medicine-Anesthesiology

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): December 31, 2016
• Study Completion (Anticipated): December 31, 2016

Study Registration Dates

• First Submitted: July 1, 2014
• First Submitted That Met QC Criteria: July 2, 2014
• First Posted (Estimate): July 3, 2014

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Pain; Neurologic Manifestations; Cysts; Connective Tissue Diseases; Mucinoses; Headache Disorders; Headache Disorders, Secondary; Headache; Ganglion Cysts; Synovial Cyst; Post-Dural Puncture Headache; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 14-024