drugset / Trial / NCT04017741

A Study Investigating the Efficacy of GON Blocks.

NCT04017741 ↗

Phase 4 Completed 8 enrolled Barts & The London NHS Trust
RandomizedCrossoverDouble-blindPrevention

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.

Timeline

Start
2018-02-14
Primary completion
2019-12-31
Completion
2020-01-23

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lidocaine Other / unclassified 2 ml Other
Comparator Methylprednisolone Other / unclassified 80 mg Other

Indications