A Study Investigating the Efficacy of GON Blocks.

Summary

Greater occipital nerve block ("GON block") is carried out extensively in the treatment of chronic migraine, but more research is required to understand the effectiveness of the procedure. It consists of a superficial injection of local anaesthetic and steroid around a nerve at the back of the head that supplies sensation to part of the scalp. This study intends to provide more detailed information on the effectiveness, safety and tolerability of GON block with local anaesthetic and steroid in patients with chronic migraine. It does this by comparing it to a dummy (placebo) procedure (a needle is inserted near the nerve, but no therapeutic substance is injected). It is a "cross-over study": all patients will receive both the GON block and the dummy procedure (not necessarily in that order), with a period in between to assess the response to the first injection. The GON block will entail an injection of 2 mls of 2% lidocaine (a local anaesthetic) and 80 mg of DepoMedrone (a steroid) through a fine needle (a total of 4 mls). The dummy procedure will consist of an injection of 4 mls of normal saline (a solution of common salt and water) through a fine needle. Patients will be followed up at various time points throughout 6 months whilst being enrolled on the study.

Conditions

• Migraine
• Chronic Migraine, Headache

Interventions

DRUG

Combined Depo-Medrone and Lidocaine

Patients will be randomised 1:1 to receive the active or placebo arm. The nerve is located along the superior nuchal line, where it bilaterally lies medial to the occipital artery. The scalp is prepped with alcohol and using 23G needle, the IMPs are injected at a 90 degrees angle till the bony endpoint is obtained. A combination of 2 mls of 2% lidocaine and 80mg methylprednisolone will be administered. Patients who no longer receive any benefit will be crossed over to the placebo arm.

DRUG

Sodium Chloride 0.9% Inj

Patients will be randomised 1:1 to receive the active or placebo arm. The nerve is located along the superior nuchal line, where it bilaterally lies medial to the occipital artery. The scalp is prepped with alcohol and using 23G needle the 4mls of normal saline (0.9%) are injected at a 90 degrees angle till the bony endpoint is obtained. Patients who no longer receive any benefit will be crossed over to the active arm.

Sponsors & Collaborators

• Barts & The London NHS Trust

  lead OTHER

Principal Investigators

• Anish Bahra · University College London Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-14

Primary Completion

2019-12-31

Completion

2020-01-23

Countries

• United Kingdom

Study Locations