Clinical Trial: A Research Study of Greater Occipital Nerve Block as a Treatment for Acute Migraine Attacks

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Double-Blind, Placebo Controlled Trial of Greater Occipital Nerve Block for the Treatment of Migraine Attacks

Brief Summary: Several observational studies have shown improvement in episodic migraine with the use of greater occipital nerve block as an acute therapy, and a recent placebo controlled trial did not show a decrease in frequency of episodic or chronic migraine; however, there has never been a placebo controlled trial to investigate the efficacy of GONB as an acute treatment for headache, and there has been no determination of guidelines for selection of patients who would be most likely to respond to GONB. In light of the above, the investigators propose a double-blind, placebo-controlled, randomized trial examining the use of GONB with lidocaine/bupivocaine in patients with an acute episodic migraine. The results of this trial are expected to guide more appropriate therapeutic management of these participants and the optimal use of this procedure. 50 subjects will be entered into this study. This study is being conducted at Thomas Jefferson University only.

Detailed Summary:
Sponsor: Thomas Jefferson University

Current Primary Outcome: Percentage of subjects experiencing headache improvement at 2 hours [ Time Frame: 2 hours ]

Headache intensity on 4 point pain scale from moderate or severe to mild or none


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of subjects experiencing headache improvement 10 minutes [ Time Frame: 10 minutes ]
    Headache intensity on 4 point pain scale from moderate or severe to mild or none.
  • Percentage of subjects experiencing headache improvement at 30 minutes [ Time Frame: 30 minutes ]
    Headache intensity on 4 point pain scale from moderate or severe to mild or none.
  • Percentage of subjects experiencing headache improvement at 1 hour [ Time Frame: 1 hour ]
    Headache intensity on 4 point pain scale from moderate or severe to mild or none.
  • Percentage of subjects experiencing headache improvement at 24 hours [ Time Frame: 24 hours ]
    Headache intensity on 4 point pain scale from moderate or severe to mild or none.
  • Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 10 minutes [ Time Frame: 10 minutes ]
    Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
  • Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 30 minutes [ Time Frame: 30 minutes ]
    Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
  • Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 1 hour [ Time Frame: 1 hour ]
    Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
  • Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 2 hours [ Time Frame: 2 hours ]
    Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia
  • Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured at 24 hours [ Time Frame: 24 hours ]
    Resolution of headache associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia and allodynia


Original Secondary Outcome: Same as current

Information By: Thomas Jefferson University

Dates:
Date Received: April 26, 2017
Date Started: May 1, 2017
Date Completion: June 30, 2018
Last Updated: May 16, 2017
Last Verified: May 2017