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 |
| Study Type : | Interventional (Clinical Trial) |
| 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 1, 2018 |
| Actual Primary Completion Date : | June 1, 2019 |
| Actual Study Completion Date : | October 30, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: lyrica, vronogabic (pregabalin)
Patients would receive oral pregabalin
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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
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Active Comparator: pulsed radiofrequency ablation of the dorsal root ganglion und
Patients would receive pulsed radiofrequency ablation of dorsal root ganglion
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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
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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.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Egypt | |
| Mansoura University | |
| Mansoura, DK, Egypt, 050 | |
| 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 |
| Tracking Information | |||||||||||||||
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| First Submitted Date ICMJE | May 3, 2019 | ||||||||||||||
| First Posted Date ICMJE | May 8, 2019 | ||||||||||||||
| Last Update Posted Date | September 7, 2020 | ||||||||||||||
| Actual Study Start Date ICMJE | January 1, 2018 | ||||||||||||||
| Actual Primary Completion Date | June 1, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
| Change History | |||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
| Descriptive Information | |||||||||||||||
| Brief Title ICMJE | Pregabalin Versus Pulsed Radiofrequency Ablation for Treatment of Chronic Post-thoracotomy Pain | ||||||||||||||
| Official Title ICMJE | Pregabalin Versus Pulsed Radiofrequency Ablation of Dorsal Root Ganglion for Treatment of Chronic Post Thoracotomy Pain Syndrome | ||||||||||||||
| 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. |
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| 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 Type ICMJE | Interventional | ||||||||||||||
| Study Phase ICMJE | Not Applicable | ||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Chronic Post-thoracotomy Pain | ||||||||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||
| Actual Enrollment ICMJE |
30 | ||||||||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
| Actual Study Completion Date ICMJE | October 30, 2019 | ||||||||||||||
| Actual Primary Completion Date | June 1, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
| Listed Location Countries ICMJE | Egypt | ||||||||||||||
| Removed Location Countries | |||||||||||||||
| Administrative Information | |||||||||||||||
| NCT Number ICMJE | NCT03942796 | ||||||||||||||
| Other Study ID Numbers ICMJE | MS/17.12.159 | ||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Mansoura University | ||||||||||||||
| Study Sponsor ICMJE | Mansoura University | ||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||
| Investigators ICMJE |
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| PRS Account | Mansoura University | ||||||||||||||
| Verification Date | September 2020 | ||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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