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Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain

Primary Purpose

Craniofacial Pain, Migraine, Cluster Headache

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exparel (Bupivacaine Liposome)
Saline
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Craniofacial Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a chief complaint of craniofacial pain (migraine, cluster headache, trigeminal autonomic cephalgia, sphenopalatine ganglioneuraligia, paroxysmal hemicrania) who has Stanford Pain & ENT clinic visit

Exclusion Criteria:

  • age <18 or >80
  • pregnant women
  • economically disadvantaged (not able to afford clinic visits/treatments)
  • decisionally impaired (unable to obtain informed consent)
  • has allergy to bupivacaine
  • unable or unwilling to participate plans to participate in another clinical study at any time during this study

Sites / Locations

  • Peter H HwangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Exparel

Saline

Arm Description

Patients receive an endoscopically guided injection of Exparel (Bupivacaine).

Patients receive an endoscopically guided injection of saline

Outcomes

Primary Outcome Measures

Change of Pain Score
Scores range from 0-10 (0=no pain, 10=worst pain)

Secondary Outcome Measures

Change of Associated Symptoms
Changes of associated symptoms, including nausea, photophobia, use of rescue medication, relapse of headache, and/or change in headache disability scores

Full Information

First Posted
June 11, 2021
Last Updated
April 12, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04930887
Brief Title
Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain
Official Title
Prospective, Randomized, Double-blinded, Placebo-controlled, Cross-over Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) Towards the Ipsilateral Pterygopalatine Fossa for the Treatment of Craniofacial Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Exparel has a proven efficacy in providing pain relief for up to 72 hours with a single-dose administration at surgical sites. The study aims to evaluate the effectiveness of endoscopically-guided injection of Exparel (Bupivacaine) for the treatment of craniofacial pain. This study would be conducted in a prospective, randomized, double-blinded, placebo- controlled, and cross-over fashion. We aim to investigate whether the administration of Exparel (Bupivacaine) to the lateral nasal wall may positively impact craniofacial pain and functional outcomes, in patients who experience relief with the topical application of Lidocaine (routinely given prior to almost all ENT endoscopy).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniofacial Pain, Migraine, Cluster Headache, Trigeminal Autonomic Cephalgia, Sphenopalatine Ganglion Neuralgia, Paroxysmal Hemicrania

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exparel
Arm Type
Active Comparator
Arm Description
Patients receive an endoscopically guided injection of Exparel (Bupivacaine).
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Patients receive an endoscopically guided injection of saline
Intervention Type
Drug
Intervention Name(s)
Exparel (Bupivacaine Liposome)
Intervention Description
Non-opioid postsurgical analgesic used in the management of postsurgical pain; 133 mg/10 mL (13.3 mg/mL) single-dose vial (per Pacira), study administers 3cc bilaterally
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Prescription medicine used for fluid and electrolyte replenishment for intravenous administration; Exparel-matched Placebo treatment
Primary Outcome Measure Information:
Title
Change of Pain Score
Description
Scores range from 0-10 (0=no pain, 10=worst pain)
Time Frame
Baseline to day 21
Secondary Outcome Measure Information:
Title
Change of Associated Symptoms
Description
Changes of associated symptoms, including nausea, photophobia, use of rescue medication, relapse of headache, and/or change in headache disability scores
Time Frame
Baseline to day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a chief complaint of craniofacial pain (migraine, cluster headache, trigeminal autonomic cephalgia, sphenopalatine ganglioneuraligia, paroxysmal hemicrania) who has Stanford Pain & ENT clinic visit Exclusion Criteria: age <18 or >80 pregnant women economically disadvantaged (not able to afford clinic visits/treatments) decisionally impaired (unable to obtain informed consent) has allergy to bupivacaine unable or unwilling to participate plans to participate in another clinical study at any time during this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Hwang, MD
Phone
(650) 723-5281
Email
hwangph@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Hwang, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peter H Hwang
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter H Hwang
Phone
650-380-9590
Email
hwangph@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be kept confidential and private and won't be used for any other studies or shared with other researchers.

Learn more about this trial

Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain

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