Pregabalin Versus Pulsed Radiofrequency Ablation for Treatment of Chronic Post-thoracotomy Pain
- Conditions
- Chronic Post-thoracotomy Pain
- Interventions
- Drug: lyrica, vronogabic (pregabalin)
- Registration Number
- NCT03942796
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- ASA physical status III or IV
- Persistent pain score ≥ 5 on VAS for 3 months or more, not responding to traditional OTC analgesics
- Patient refusal
- The presence of pathology that could account for a majority of persistent symptoms (e.g. recurrent cancer)
- coagulopathy
- Uncooperative patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lyrica, vronogabic (pregabalin) lyrica, vronogabic (pregabalin) Patients would receive oral pregabalin
- Primary Outcome Measures
Name Time Method Change in the severity of pain 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
Name Time Method the number of patients who developed somnolence as a side effect of treatment 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.
The number of patients who developed nausea as a side effect of treatment immediately after the intervention, 2weeks, 1, 2, 3 months a feeling of sickness with an inclination to vomit.
the number of patients who needed rescue analgesia 2weeks, 1, 2, 3 months the Cumulative use of rescue analgesics
the number of patients who developed dizziness as a side effect of treatment immediately after the intervention, 2weeks, 1, 2, 3 months a sensation of unsteadiness accompanied by a feeling of movement within the head
The number of patients who developed imbalance as a side effect of treatment immediately after the intervention, 2weeks, 1, 2, 3 months the state of being out of equilibrium or out of proportion
The number of patients who developed constipation as a side effect of treatment 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.
The number of patients who developed pneumothorax as a side effect of treatment 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
Patient satisfaction 2weeks, 1, 2, 3 months Using score including 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor
Trial Locations
- Locations (1)
Mansoura University
🇪🇬Mansoura, DK, Egypt