Clinical trial NCT03942796: Pregabalin Versus Pulsed Radiofrequency Ablation for Treatment of Chronic Post-thoracotomy Pain
Official title: Pregabalin Versus Pulsed Radiofrequency Ablation of Dorsal Root Ganglion for Treatment of Chronic Post Thoracotomy Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Post-thoracotomy Pain
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in the severity of pain
timeFrame: day 1, 3 months
Secondary outcomes:
measure: the number of patients who needed rescue analgesia
timeFrame: 2weeks, 1, 2, 3 months
measure: the number of patients who developed somnolence as a side effect of treatment
timeFrame: immediately after the intervention, 2weeks, 1, 2, 3 months
measure: the number of patients who developed dizziness as a side effect of treatment
timeFrame: immediately after the intervention, 2weeks, 1, 2, 3 months
measure: The number of patients who developed nausea as a side effect of treatment
timeFrame: immediately after the intervention, 2weeks, 1, 2, 3 months
measure: The number of patients who developed imbalance as a side effect of treatment
timeFrame: immediately after the intervention, 2weeks, 1, 2, 3 months
measure: The number of patients who developed constipation as a side effect of treatment
timeFrame: immediately after the intervention, 2weeks, 1, 2, 3 months
measure: The number of patients who developed pneumothorax as a side effect of treatment
timeFrame: immediately after the intervention, 2weeks, 1, 2, 3 months
measure: Patient satisfaction
timeFrame: 2weeks, 1, 2, 3 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Professor of Anesthesia and Surgical Intensive Care
name: Gamal M El-Morsy, MD
role: STUDY_CHAIR
affiliation: Assistant Professor of Anesthesia and Surgical Intensive Care
name: Hazem S Maawad, MD
role: STUDY_DIRECTOR
References: