Pregabalin Versus Pulsed Radiofrequency Ablation for Treatment of Chronic Post-thoracotomy Pain
Condition: Chronic Post-thoracotomy Pain
Study type: Interventional

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.
    

Intervention name(s): lyrica, vronogabic (pregabalin); pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation device name: Neuro Therm TM 1100
Intervention type(s): Drug; Procedure
Intervention description(s): 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; 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
Other intervention name(s): lyrica, vronogabic; pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment