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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Post-thoracotomy Pain
• Intervention / Treatment: Drug: lyrica, vronogabic (pregabalin); Procedure: pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation device name: Neuro Therm TM 1100

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 050
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA physical status III or IV
• Persistent pain score ≥ 5 on VAS for 3 months or more, not responding to traditional OTC analgesics

Exclusion Criteria:

• Patient refusal
• The presence of pathology that could account for a majority of persistent symptoms (e.g. recurrent cancer)
• coagulopathy
• Uncooperative patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: lyrica, vronogabic (pregabalin); Patients would receive oral pregabalin	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; Other Names: lyrica, vronogabic
Active Comparator: pulsed radiofrequency ablation of the dorsal root ganglion und; Patients would receive pulsed radiofrequency ablation of dorsal root ganglion	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; Other Names: pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the severity of pain	measured by 11 point VAS score from 0 to 10. the patient is asked to report the severity of his pain in which 0 represents no pain and 10 is the maximum pain. VAS below 5 is considered a "successful" outcome of the treatment method and VAS score ≥ 5 is considered a "failure" outcome. In case of a "failure" outcome, patients will be given oral acetaminophen 500 mg every 8 hours and/or oral ibuprofen 400 mg every 8-12 hours and the need for rescue analgesia will be recorded. is measured by 11 point VAS score from 0 to 10. the patient is asked to report the severity of his pain in which 0 represents no pain and 10 is the maximum pain. VAS below 5 is considered a "success" outcome of the treatment method and VAS score ≥ 5 is considered a "failure" outcome. In case of a "failure" outcome, patients will be given oral acetaminophen 500 mg every 8 hours and/or oral ibuprofen 400 mg every 8-12 hours and the need for rescue analgesia will be recorded.	day 1, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of patients who needed rescue analgesia	the Cumulative use of rescue analgesics	2weeks, 1, 2, 3 months
the number of patients who developed somnolence as a side effect of treatment	somnolence or excessive daytime sleepiness (EDS) refers to the tendency to fall asleep in inappropriate settings.	immediately after the intervention, 2weeks, 1, 2, 3 months
the number of patients who developed dizziness as a side effect of treatment	a sensation of unsteadiness accompanied by a feeling of movement within the head	immediately after the intervention, 2weeks, 1, 2, 3 months
The number of patients who developed nausea as a side effect of treatment	a feeling of sickness with an inclination to vomit.	immediately after the intervention, 2weeks, 1, 2, 3 months
The number of patients who developed imbalance as a side effect of treatment	the state of being out of equilibrium or out of proportion	immediately after the intervention, 2weeks, 1, 2, 3 months
The number of patients who developed constipation as a side effect of treatment	a condition in which there is difficulty in emptying the bowels, usually associated with hardened stool.	immediately after the intervention, 2weeks, 1, 2, 3 months
The number of patients who developed pneumothorax as a side effect of treatment	an abnormal collection of air in the pleural space between the lung and the chest wall, diagnosed by chest xray	immediately after the intervention, 2weeks, 1, 2, 3 months
Patient satisfaction	Using score including 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor	2weeks, 1, 2, 3 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Gamal M El-Morsy, MD, Professor of Anesthesia and Surgical Intensive Care; Study Director: Hazem S Maawad, MD, assistant professor of Anesthesia and Surgical Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): September 7, 2020
• Last Update Submitted That Met QC Criteria: September 4, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: MS/17.12.159

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected IPD
• IPD Sharing Time Frame: Starting 6 months after publication and for 1 year
• IPD Sharing Access Criteria: Open access
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No