Chronic Post-thoracotomy PainNCT03942796
Pregabalin Versus Pulsed Radiofrequency Ablation for Treatment of Chronic Post-thoracotomy Pain
A study testing lyrica, vronogabic (pregabalin) and pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation device name: Neuro Therm TM 1100 in people with Chronic Post-thoracotomy Pain, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Post-thoracotomy Pain
- What is being tested?
- lyrica, vronogabic (pregabalin) and pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation device name: Neuro Therm TM 1100
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status III or IV
- Persistent pain score ≥ 5 on VAS for 3 months or more, not responding to traditional OTC analgesics
Who cannot join
- Patient refusal
- The presence of pathology that could account for a majority of persistent symptoms (e.g. recurrent cancer)
- coagulopathy
- Uncooperative patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pregabalin Versus Pulsed Radiofrequency Ablation of Dorsal Root Ganglion for Treatment of Chronic Post Thoracotomy Pain Syndrome
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.
Read the 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.
- Conditions
- Chronic Post-thoracotomy Pain
- Being tested
- lyrica, vronogabic (pregabalin), pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation device name: Neuro Therm TM 1100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lyrica, vronogabic (pregabalin)Drug
Also called lyrica, vronogabic
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
pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation device name: Neuro Therm TM 1100Procedure or surgery
Also called pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation
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
| Study group | Role | What they receive |
|---|---|---|
| lyrica, vronogabic (pregabalin) | Active comparator | Patients would receive oral pregabalin Receives: Drug: lyrica, vronogabic (pregabalin) |
| pulsed radiofrequency ablation of the dorsal root ganglion und | Active comparator | Patients would receive pulsed radiofrequency ablation of dorsal root ganglion Receives: Procedure: pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation device name: Neuro Therm TM 1100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the severity of pain
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.
Measured: day 1, 3 months
Secondary outcomes (8)
the number of patients who needed rescue analgesia
the Cumulative use of rescue analgesics
Measured: 2weeks, 1, 2, 3 months
the number of patients who developed somnolence as a side effect of treatment
somnolence or excessive daytime sleepiness (EDS) refers to the tendency to fall asleep in inappropriate settings.
Measured: immediately after the intervention, 2weeks, 1, 2, 3 months
the number of patients who developed dizziness as a side effect of treatment
a sensation of unsteadiness accompanied by a feeling of movement within the head
Measured: immediately after the intervention, 2weeks, 1, 2, 3 months
The number of patients who developed nausea as a side effect of treatment
a feeling of sickness with an inclination to vomit.
Measured: immediately after the intervention, 2weeks, 1, 2, 3 months
The number of patients who developed imbalance as a side effect of treatment
the state of being out of equilibrium or out of proportion
Measured: immediately after the intervention, 2weeks, 1, 2, 3 months
The number of patients who developed constipation as a side effect of treatment
a condition in which there is difficulty in emptying the bowels, usually associated with hardened stool.
Measured: immediately after the intervention, 2weeks, 1, 2, 3 months
The number of patients who developed pneumothorax as a side effect of treatment
an abnormal collection of air in the pleural space between the lung and the chest wall, diagnosed by chest xray
Measured: immediately after the intervention, 2weeks, 1, 2, 3 months
Patient satisfaction
Using score including 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor
Measured: 2weeks, 1, 2, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start1 Jan 2018
- Primary completion1 Jun 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Post-thoracotomy PainStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gamal M El-Morsy, MD, Study chair, Professor of Anesthesia and Surgical Intensive CareHazem S Maawad, MD, Study director, Assistant Professor of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942796
- Sponsor's protocol ID
- MS/17.12.159
- Status last verified
- Sep 2020
- First submitted
- 3 May 2019
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregabalin Versus Pulsed Radiofrequency Ablation of Dorsal Root Ganglion for Treatment of Chronic Post Thoracotomy Pain Syndrome
- ClinicalTrials.gov ID
- NCT03942796
- Acronym / sponsor ID
- MS/17.12.159
- Conditions
- Chronic Post-thoracotomy Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lyrica, vronogabic (pregabalin) | Active comparator | Drug: lyrica, vronogabic (pregabalin)Patients would receive oral pregabalin |
| pulsed radiofrequency ablation of the dorsal root ganglion und | Active comparator | Procedure: pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation device name: Neuro Therm TM 1100Patients would receive pulsed radiofrequency ablation of dorsal root ganglion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status III or IV
- Persistent pain score ≥ 5 on VAS for 3 months or more, not responding to traditional OTC analgesics
Key exclusion criteria (4 listed)
- Patient refusal
- The presence of pathology that could account for a majority of persistent symptoms (e.g. recurrent cancer)
- coagulopathy
- Uncooperative patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lyrica, vronogabic (pregabalin)Also: lyrica, vronogabicPatients 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 | Drug | lyrica, vronogabic (pregabalin) |
| pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation device name: Neuro Therm TM 1100Also: pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervationPatients 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 | Procedure or surgery | pulsed radiofrequency ablation of the dorsal root ganglion und |
Primary outcome
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.
8 secondary outcomes
the number of patients who needed rescue analgesia
Time frame: 2weeks, 1, 2, 3 months
the number of patients who developed somnolence as a side effect of treatment
Time frame: immediately after the intervention, 2weeks, 1, 2, 3 months
the number of patients who developed dizziness as a side effect of treatment
Time frame: immediately after the intervention, 2weeks, 1, 2, 3 months
The number of patients who developed nausea as a side effect of treatment
Time frame: immediately after the intervention, 2weeks, 1, 2, 3 months
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 number of patients who developed constipation as a side effect of treatment
Time frame: immediately after the intervention, 2weeks, 1, 2, 3 months
The number of patients who developed pneumothorax as a side effect of treatment
Time frame: immediately after the intervention, 2weeks, 1, 2, 3 months
Patient satisfaction
Time frame: 2weeks, 1, 2, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Individual participant dataSharing planned: Yes. All collected IPD
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamal M El-Morsy, MD study chair
Professor of Anesthesia and Surgical Intensive Care
Hazem S Maawad, MD study director
Assistant Professor of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lyrica, vronogabic (pregabalin) and pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation device name: Neuro Therm TM 1100 in people with Chronic Post-thoracotomy Pain, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the severity of pain (time frame: day 1, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.