Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 39 of 424 for:    Pregabalin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03942796
Recruitment Status : Enrolling by invitation
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Mansoura University

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 Intervention/treatment Phase
Chronic Post-thoracotomy Pain 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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

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 Name: 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 Name: pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942796


Locations
Layout table for location information
Egypt
Mansoura University
Mansoura, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University
Investigators
Layout table for investigator information
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

Layout table for additonal 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: May 8, 2019
Last Verified: May 2019
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs