A Randomized Controlled Trial Comparing the Effect of Two-Time Durations of Balloon Compression During Percutaneous Balloon Compression in Resistant Trigeminal Neuralgia

Abstract

BACKGROUND: Percutaneous balloon compression of the trigeminal nerve’s gasserian ganglion for the treatment of trigeminal neuralgia is an interventional pain procedure with results comparable to microvascular decompression surgery. The procedure is safe in experienced hands and has less morbidity associated with it. However, there is a lack of clear-cut guidelines about the details of the technique like balloon shape, inflation pressure, and duration of inflation. So, keeping the inflation pressure and shape of the balloon constant, we studied the effect of the duration of inflation of the balloon and its effect on pain relief in refractory trigeminal neuralgia cases. OBJECTIVES: To study the outcome with 2 different durations of balloon inflation times in terms of pain relief and complications after percutaneous balloon compression. STUDY DESIGN: Prospective parallel design randomized, controlled trial. SETTING: The study was conducted in a tertiary care hospital in North Eastern India after obtaining approval from the Institutes’ ethics committee (Dean/2018/EC/449). The study was also registered with the Clinical Trials Registry of India (CTRI no. CTRI/2019/03/018166). All patients referred to a pain clinic for unilateral facial pain were screened for the study over 2 years from April 2019 to March 2021. METHODS: Forty patients who met the diagnosis of trigeminal neuralgia and who did not respond satisfactorily to medications were included in the study. They underwent routine blood investigations and a magnetic resonance image of the brain to rule out any medical or surgical conditions. Percutaneous balloon compression was conducted under C-arm guidance using a 12 gauge cannula and a 4 Fr Fogarty balloon was used for compressing the gasserian rootlets. RESULTS: Patients who underwent 90 seconds as well as 120 seconds showed good pain relief. The 2 groups did not show any significant difference in pain relief based on the duration of compression. Visual analog scale scores were reduced from 7-8 to 0-3. Masseter muscle weakness was present in 47.5% of patients post-procedure and recovered in all except one patient. LIMITATIONS: We have followed up with our patients for a short period of 6 months only. We could not measure the intra-luminal compression pressure of the balloon. CONCLUSION: There is no difference in the pain relief obtained by the 2 different durations of compressions. A longer duration of compression, however, has more incidence of side effects. KEY WORDS: Idiopathic trigeminal neuralgia, percutaneous balloon compression, time duration, shape of balloon, masseter muscle weakness, facial numbness, corneal dysesthesia