NCT03942796

Pregabalin Versus Pulsed Radiofrequency Ablation for Treatment of Chronic Post-thoracotomy Pain

Pregabalin Versus Pulsed Radiofrequency Ablation of Dorsal Root Ganglion for Treatment of Chronic Post Thoracotomy Pain Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Chronic Post thoracotomy pain syndrome (PTPS) is defined PTPS as pain that develops or increases in intensity after a thoracotomy and persists beyond the healing process, that's to say at least 3 months after the initiating event. The pain has to be localized to the site of incision or, projected to the innervation territory of a nerve situated in this area or referred to a dermatome or Head's zone (after surgery/injury to deep somatic and visceral tissues The incidence of PTPS is 57% and 47% of patients at 3 and 6 months after thoracotomy, respectively. Management of PTPS begins with prevention. Preventive strategies are based on multimodal preemptive and intraoperative analgesia. Treatment of PTPS is either pharmacologic treatment which is systematically initiated by first line drugs including tricyclic anti-depressants (TCA), serotonin-norepinephrine reuptake inhibitors (SNRI), gabapentinoids. Second-line treatments include topical lidocaine, capsaicin, and weak opioid analgesics (tramadol). Third line treatments consist of strong opioids (oxycodone, morphine) and subcutaneous botilinium toxin injection. Other therapies for management of CPTP include such modalities as transcutaneous electrical nerve stimulation (TENS), Spinal cord and peripheral nerve stimulation, acupuncture and neurolysis using pulsed radiofrequency for intercostal nerve or dorsal root ganglio and cryoneurolysis for intercostal nerve. The mode of action of pulsed RF is not well-understood, but may include inhibition of excitatory C-fiber responses by repetitive, burst-like stimulation of A-delta fibers, global reduction of evoked synaptic activity and minor structural changes in nerve tissue; elicited by alterations in the function of the blood-nerve barrier, fibroblast activation and collagen deposition.

Detailed description

The aim of the work is to evaluate the effect of oral pregabalin and pulsed radiofrequency ablation (PRF) ablation of the dorsal root ganglion (DRG) in the treatment of chronic post thoracotomy pain syndrome, using Visual Analogue Scale (VAS) score.

Conditions

• Chronic Post-thoracotomy Pain

Interventions

Type	Name	Description
DRUG	lyrica, vronogabic (pregabalin)	Patients would receive oral pregabalin is initiated at a dose of 75 mg twice daily and titrated up to 600 mg as tolerated by the patient at 1,2,3 weeks
PROCEDURE	pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation device name: Neuro Therm TM 1100	Patients would receive pulsed radiofrequency ablation of dorsal root ganglion using the following settings: 2-Hz frequency, 20-ms pulses in a 1 second cycle, 120 second duration and 42°C temperature. Impedance ranges between 150 and 400 Ohms at all levels under fluroscopic guidance. For each pulsed RF application, the procedure will be repeated 4 times, for a total duration of 8 minutes

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-06-01
• Completion: 2019-10-30
• First posted: 2019-05-08
• Last updated: 2020-09-07

Locations

1 site across 1 country: Egypt