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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

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

Clinicaltrials.gov identifier NCT03942796

Recruitment Status Completed

First Posted May 8, 2019

Last update posted September 7, 2020

Study Description

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.

  • Condition or Disease: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
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Actual Enrollment: 30 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Pregabalin Versus Pulsed Radiofrequency Ablation of Dorsal Root Ganglion for Treatment of Chronic Post Thoracotomy Pain Syndrome
  • Actual Study Start Date: January 2018
  • Actual Primary Completion Date: June 2019
  • Actual Study Completion Date: October 2019
Arms and interventions
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
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
Outcome Measures
  • Primary Outcome Measures: 1. Change in the severity of pain [ Time Frame: day 1, 3 months ]
    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.
  • Secondary Outcome Measures: 1. the number of patients who needed rescue analgesia [ Time Frame: 2weeks, 1, 2, 3 months ]
    the Cumulative use of rescue analgesics
  • 2. the number of patients who developed somnolence as a side effect of treatment [ Time Frame: immediately after the intervention, 2weeks, 1, 2, 3 months ]
    somnolence or excessive daytime sleepiness (EDS) refers to the tendency to fall asleep in inappropriate settings.
  • 3. the number of patients who developed dizziness as a side effect of treatment [ Time Frame: immediately after the intervention, 2weeks, 1, 2, 3 months ]
    a sensation of unsteadiness accompanied by a feeling of movement within the head
  • 4. The number of patients who developed nausea as a side effect of treatment [ Time Frame: immediately after the intervention, 2weeks, 1, 2, 3 months ]
    a feeling of sickness with an inclination to vomit.
  • 5. The number of patients who developed imbalance as a side effect of treatment [ Time Frame: immediately after the intervention, 2weeks, 1, 2, 3 months ]
    the state of being out of equilibrium or out of proportion
  • 6. The number of patients who developed constipation as a side effect of treatment [ Time Frame: immediately after the intervention, 2weeks, 1, 2, 3 months ]
    a condition in which there is difficulty in emptying the bowels, usually associated with hardened stool.
  • 7. The number of patients who developed pneumothorax as a side effect of treatment [ Time Frame: immediately after the intervention, 2weeks, 1, 2, 3 months ]
    an abnormal collection of air in the pleural space between the lung and the chest wall, diagnosed by chest xray
  • 8. Patient satisfaction [ Time Frame: 2weeks, 1, 2, 3 months ]
    Using score including 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor
Eligibility Criteria
  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts
Locations

Egypt, DK
Mansoura University
Mansoura

Sponsors and Collaborators

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

More Information
  • Responsible Party: Mansoura University
  • ClinicalTrials.gov Identifier: NCT03942796 History of Changes
  • Other Study ID Numbers: MS/17.12.159
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: September 7, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: All collected IPD
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF)
  • Time Frame: Starting 6 months after publication and for 1 year
  • Access Criteria: Open access
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No