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

NCT03942796 | Completed DMC

• 1 other identifier: MS/17.12.159
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• the number of patients who needed rescue analgesia

  2weeks, 1, 2, 3 months

• the number of patients who developed somnolence as a side effect of treatment

  immediately after the intervention, 2weeks, 1, 2, 3 months

• the number of patients who developed dizziness as a side effect of treatment

  immediately after the intervention, 2weeks, 1, 2, 3 months

• The number of patients who developed nausea as a side effect of treatment

  immediately after the intervention, 2weeks, 1, 2, 3 months

• The number of patients who developed imbalance as a side effect of treatment

  immediately after the intervention, 2weeks, 1, 2, 3 months

Study Arms (2)

lyrica, vronogabic (pregabalin)

ACTIVE COMPARATOR

Patients would receive oral pregabalin

Drug: lyrica, vronogabic (pregabalin)

pulsed radiofrequency ablation of the dorsal root ganglion und

ACTIVE COMPARATOR

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

Interventions

lyrica, vronogabic (pregabalin) DRUG

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

Also known as: lyrica, vronogabic

lyrica, vronogabic (pregabalin)

pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation device name: Neuro Therm TM 1100 PROCEDURE

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

Also known as: pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation

pulsed radiofrequency ablation of the dorsal root ganglion und

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Gamal M El-Morsy, MD

  Professor of Anesthesia and Surgical Intensive Care

  STUDY CHAIR

• Hazem S Maawad, MD

  Assistant Professor of Anesthesia and Surgical Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 8, 2019
• Study Start: January 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: October 30, 2019
• Last Updated: September 7, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication and for 1 year
• Access Criteria: Open access

Locations

EG (1)