Post-thoracotomy Pain SyndromeNCT05379816
Persistent Pain Induced by Uniportal Video-assisted Thoracic Surgery
A study testing 5% DW perineural injection in people with Post-thoracotomy Pain Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators investigate the prevalence of PTPS in patients receiving with uniportal video-assisted thoracic surgery (VATS), and early identify neuropathic pain as well as treated with neural protective strategy to target intercostal nerve. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Post-thoracotomy Pain Syndrome
- What is being tested?
- 5% DW perineural injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 May 2022to 31 Dec 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PTPS after single port VATS
Who cannot join
- abnormal sensation
- can not complete questionnaire
- others cause of pain
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National taiwan university cancer center
Taipei, 106
Wen-ying Lin, Dr.
About this study
Official title: A Prospective Study of Persistent Pain Induced by Uniportal Video-assisted Thoracic Surgery: Incidence, Diagnosis, and Intercostal Nerve Treatment
The investigators investigate the prevalence of PTPS in patients receiving with uniportal video-assisted thoracic surgery (VATS), and early identify neuropathic pain as well as treated with neural protective strategy to target intercostal nerve.
Read the detailed description
More than 30% of patients have persistent pain after thoracic surgery. Intercostal neuralgia is characterized by neuropathic pain in the distribution of affected intercostal nerve(s) (along the ribs, chest, or abdomen) that commonly manifests as a sharp, aching, radiating, burning, or stabbing pain and may be associated with paresthesia such as numbness and tingling. The pain may be intermittent or constant and typically presents as a band-like pain that is wrapped around the chest and back or in a thoracic dermatomal pattern. Pain may last for a prolonged period and may continue long after the disease process has subsided.
Hypertonic dextrose injection (prolotherapy) is reported to reduce pain, including non-surgical chronic low back pain (CLBP), and subcutaneous injection of 5% dextrose is said to minimize neurogenic pain hyperalgesia and allodynia. The mechanism in both cases is unclear, though a direct effect of dextrose on neurogenic pain has been proposed. This study assessed the short-term analgesic effects of epidural 5% dextrose injection compared with saline for non-surgical CLBP.
Intercostal nerve damage is a suspected pathogenic mechanism for developing post-thoracotomy pain syndrome (PTPS). Video-assisted thoracic surgery (VATS) is a minimally invasive procedure that potentially reduces PTPS. However, there was no specific outcome study for uniportal VATS.
In this study, the investigators investigate the prevalence of PTPS in patients receiving uniportal video-assisted thoracic surgery (VATS), identify neuropathic pain early, and treat it with a neural protective strategy to target intercostal pain nerve.
- Conditions
- Post-thoracotomy Pain Syndrome
- Being tested
- 5% DW perineural injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% DW perineural injectionProcedure or surgery
5% DW perineural injection to intercostal nerve
| Study group | Role | What they receive |
|---|---|---|
| conservative treatment | No intervention | analgesics are used for PTPS |
| Interventional treatment | Active comparator | perineural injection Receives: Procedure: 5% DW perineural injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
difference of Numerical rating scale, before and after
Measured: 3 months
Secondary outcomes (1)
Quantitative sensory test
difference of cold, warm, tactile detection threshold, before and after
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start3 May 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-thoracotomy Pain SyndromeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Model description
- Conservative management indicates medication treatment. Interventional treatment indicate injection treatment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-ying Lin, Dr., Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379816
- Sponsor's protocol ID
- 202108162RINA
- Status last verified
- Oct 2021
- First submitted
- 15 May 2022
- Last updated
- 24 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Persistent Pain Induced by Uniportal Video-assisted Thoracic Surgery: Incidence, Diagnosis, and Intercostal Nerve Treatment
- ClinicalTrials.gov ID
- NCT05379816
- Acronym / sponsor ID
- 202108162RINA
- Conditions
- Post-thoracotomy Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 3 May 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 May 2022 (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.
The investigators investigate the prevalence of PTPS in patients receiving with uniportal video-assisted thoracic surgery (VATS), and early identify neuropathic pain as well as treated with neural protective strategy to target intercostal nerve.
Detailed description
More than 30% of patients have persistent pain after thoracic surgery. Intercostal neuralgia is characterized by neuropathic pain in the distribution of affected intercostal nerve(s) (along the ribs, chest, or abdomen) that commonly manifests as a sharp, aching, radiating, burning, or stabbing pain and may be associated with paresthesia such as numbness and tingling. The pain may be intermittent or constant and typically presents as a band-like pain that is wrapped around the chest and back or in a thoracic dermatomal pattern. Pain may last for a prolonged period and may continue long after the disease process has subsided.
Hypertonic dextrose injection (prolotherapy) is reported to reduce pain, including non-surgical chronic low back pain (CLBP), and subcutaneous injection of 5% dextrose is said to minimize neurogenic pain hyperalgesia and allodynia. The mechanism in both cases is unclear, though a direct effect of dextrose on neurogenic pain has been proposed. This study assessed the short-term analgesic effects of epidural 5% dextrose injection compared with saline for non-surgical CLBP.
Intercostal nerve damage is a suspected pathogenic mechanism for developing post-thoracotomy pain syndrome (PTPS). Video-assisted thoracic surgery (VATS) is a minimally invasive procedure that potentially reduces PTPS. However, there was no specific outcome study for uniportal VATS.
In this study, the investigators investigate the prevalence of PTPS in patients receiving uniportal video-assisted thoracic surgery (VATS), identify neuropathic pain early, and treat it with a neural protective strategy to target intercostal pain nerve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Conservative management indicates medication treatment. Interventional treatment indicate injection treatment
| Arm | Type | Receives |
|---|---|---|
| conservative treatment | No intervention | –analgesics are used for PTPS |
| Interventional treatment | Active comparator | Procedure: 5% DW perineural injectionperineural injection |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PTPS after single port VATS
Key exclusion criteria (3 listed)
- abnormal sensation
- can not complete questionnaire
- others cause of pain
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 |
|---|---|---|
| 5% DW perineural injection5% DW perineural injection to intercostal nerve | Procedure or surgery | Interventional treatment |
Primary outcome
Pain score
Time frame: 3 months
difference of Numerical rating scale, before and after
1 secondary outcome
Quantitative sensory test
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
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.
Wen-ying Lin, Dr. principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5% DW perineural injection in people with Post-thoracotomy Pain Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 May 2022. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-ying Lin, Dr. (0972652006, ying434@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 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 24 May 2022.