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

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.

Conditions

• Chronic Post-thoracotomy Pain

Interventions

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

Sponsors & Collaborators

• Mansoura University

  lead OTHER

Principal Investigators

• Gamal M El-Morsy, MD · Professor of Anesthesia and Surgical Intensive Care

• Hazem S Maawad, MD · Assistant Professor of Anesthesia and Surgical Intensive Care

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-01

Primary Completion

2019-06-01

Completion

2019-10-30

Countries

• Egypt

Study Locations