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

Not Applicable
Completed
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
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
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Exclusion Criteria
  • Patient refusal
  • The presence of pathology that could account for a majority of persistent symptoms (e.g. recurrent cancer)
  • coagulopathy
  • Uncooperative patients
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
lyrica, vronogabic (pregabalin)lyrica, vronogabic (pregabalin)Patients would receive oral pregabalin
Primary Outcome Measures
NameTimeMethod
Change in the severity of painday 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
NameTimeMethod
the number of patients who developed somnolence as a side effect of treatmentimmediately 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 treatmentimmediately after the intervention, 2weeks, 1, 2, 3 months

a feeling of sickness with an inclination to vomit.

the number of patients who needed rescue analgesia2weeks, 1, 2, 3 months

the Cumulative use of rescue analgesics

the number of patients who developed dizziness as a side effect of treatmentimmediately 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 treatmentimmediately 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 treatmentimmediately 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 treatmentimmediately 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 satisfaction2weeks, 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

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