Thoracic SurgeryNCT07184463
A Study of Pain Reduction After Pulmonary Resection by RATS-TT, RATS-OTC, and Hybrid RATS.
An observational study of Thoracic Surgery and Video-assisted Thoracic Surgery, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Pulmonary resections are key in treating lung neoplasms, with techniques adapted to tumor size and location. Minimally invasive approaches like VATS have replaced open thoracotomy, but intercostal trocar placement can lead to nerve injury and chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Video-assisted Thoracic Surgery, Robotic-assisted Thoracic Surgery
- What is being tested?
- Evaluation of chronic pain at 3 and 6 months after thoracic surgery
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 5 Dec 2025to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective anatomical pulmonary resection (anatomical segmentectomy, lobectomy or bilobectomy) via minimally invasive approach (robotic).
Who may be able to join
- Patients aged 18 years and older
- American Society of Anesthesiologists (ASA) score 1-3
Who cannot join
- Language barrier, psychiatric, physical or mental condition making pain assessment impossible despite prior education
- Patient refusal to participate
- Patients reoperated by VATS or thoracotomy in the postoperative period in the context of the occurrence of complications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montreal
Montreal, Quebec, H2X 3E4
Alex Moore, MD, 514-890-8000 ext. 12132, alex.moore.med@ssss.gouv.qc.ca
Julie Desroches, PhD, 514-890-8000 ext. 24542, anesthesie.recherche.chum@ssss.gouv.qc.ca
About this study
Official title: Chronic Pain After Thoracic Surgery: Towards a New Standard? A Comparative Prospective Study of Pain Reduction After Pulmonary Resection by RATS-TT, RATS-OTC, and Hybrid RATS.
Pulmonary resections are key in treating lung neoplasms, with techniques adapted to tumor size and location. Minimally invasive approaches like VATS have replaced open thoracotomy, but intercostal trocar placement can lead to nerve injury and chronic pain.
Robotic-assisted thoracic surgery (RATS) is usually done via a transthoracic (RATS-TT) approach using intercostal trocars. A newer "out of cage" method (RATS-OTC), using subcostal or subxiphoid ports, avoids intercostal access, potentially reducing nerve damage. A French study showed less opioid use and acute pain with RATS-OTC, but chronic pain outcomes are still unknown.
At CHUM, a hybrid RATS technique (RATS-TTH) is also used-intercostal for instruments, but with out-of-cage specimen extraction-to limit intercostal trauma.
Read the detailed description
Pulmonary resections play a crucial role in the treatment of lung neoplasms, with procedures tailored to the size and location of the tumors. The minimally invasive approach, particularly via video-assisted thoracoscopic surgery (VATS), has replaced traditional thoracotomy by allowing access to the thoracic cavity through surgical trocars inserted between the ribs. However, these trocars, placed near the intercostal nerves, can cause nerve injury and chronic pain.
Robotic-assisted thoracic surgery (RATS) is typically performed via a transthoracic approach (RATS-TT), using intercostal trocars similar to those in VATS. Recently, a robotic approach known as "out of cage" (RATS-OTC) has been described, which involves the use of subcostal or subxiphoid trocar insertion. This method avoids the passage of instruments through the intercostal space, thus theoretically eliminating the risk of intercostal nerve injury. Compared to the transthoracic approach, a French team reported a reduction in opioid use and decreased intensity of acute postoperative pain with the RATS-OTC approach. However, due to the novelty of this technique, chronic pain outcomes have yet to be compared with those observed in RATS-TT or VATS.
At the CHUM, a modified transthoracic RATS technique-called the hybrid approach (RATS-TTH)-is also used. In this method, trocars are placed intercostally, but the extraction of large pulmonary specimens is performed through an out-of-cage route to minimize potential intercostal trauma related to specimen removal. Pain associated with this approach has also not been described in the literature.
Postoperative pain significantly affects recovery and long-term quality of life. Although the VATS approach reduces the severity of acute pain, chronic pain remains common and impactful. In fact, in the CRYO-VATS study conducted at CHUM between 2023 and 2025, the incidence of chronic pain following pulmonary resection via VATS (without cryoanalgesia) was 30% at 3 months and 17.5% at 6 months.
The aim of this study is to describe the incidence of chronic pain at 3 and 6 months for the three surgical approaches used at CHUM:
RATS-OTC (robotic, completely spares the intercostal space),
RATS-TT (robotic, intercostal passage of instruments and pulmonary specimen),
RATS-TTH (robotic, hybrid technique with intercostal instrument passage but out-of-cage extraction of the pulmonary specimen).
The investigators hypothesize that the RATS-OTC approach will reduce the incidence of chronic pain by completely eliminating intercostal trauma. Currently, no study has reported on chronic pain outcomes comparing the RATS-TTH and RATS-OTC approaches. Simultaneous data collection from patients undergoing RATS-TT will serve as a comparison baseline. These preliminary data will provide the foundation for a randomized controlled trial to validate the potential chronic pain benefits of these innovative surgical approaches.
- Being tested
- Evaluation of chronic pain at 3 and 6 months after thoracic surgery
- Keywords
- chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of chronic pain at 3 and 6 months after thoracic surgeryOther
The presence of persistent postoperative pain, defined as ipsilateral chest pain (on the same side as the surgery) occurring at rest and/or with coughing on a daily basis. Assessed by a 'yes' or 'no' response when asked at 3 and 6 months postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary resections surgery with three surgical approaches: | RATS-OTC (no intercostal access)
RATS-TT (intercostal instruments and specimen)
RATS-TTH (intercostal instruments, out-of-cage specimen) Receives: Other: Evaluation of chronic pain at 3 and 6 months after thoracic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of persistent postoperative pain
The presence of persistent postoperative pain, defined as ipsilateral chest pain (on the same side as the surgery) occurring at rest and/or with coughing on a daily basis. Assessed by a 'yes' or 'no' response when asked at 3 and 6 months postoperatively.
Measured: 3 and 6 months after surgery
Secondary outcomes (9)
Occurrence of a neuropathic pain component
The occurrence of a neuropathic pain component, assessed using the DN4-interview questionnaire, administered via telephone at 3 and 6 months to identify a neuropathic component. A score of 3 or higher is considered a positive result.
Measured: 3 and 6 months after surgery
Impact of chronic pain on overall recovery
The impact of chronic pain on overall recovery, assessed using the Brief Pain Inventory (BPI) via telephone at 3 and 6 months. A change of 2 points or more on the 10-point pain intensity scale is considered clinically significant.
Similarly, a change of at least 1 point on the pain interference score with quality of life is considered clinically significant.
Measured: 3 and 6 months after surgery
Preoperative analgesic use
Preoperative analgesic use, determined by documenting the type of medication (opioids, anti-inflammatories, neuropathic pain treatments, etc.) and the dosage taken at home prior to surgery.
Measured: On the day of the surgery
Overall recovery
Overall recovery, assessed by opioid consumption at 3 and 6 months, new prescriptions for neuropathic pain medications in the postoperative period, and whether the patient is still taking them at 3 and 6 months.
Measured: 3 and 6 months after surgery
Residual pain intensity
Residual pain intensity, assessed using the Verbal Numerical Rating Scale (VNRS) at 3 and 6 months, on a scale from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable.
Measured: 3 and 6 months after surgery
Total length of hospital stay
Total length of hospital stay, measured from the end of surgery until discharge is signed.
Measured: On the day patient is discharged from hospital, up to two weeks
Total opioid consumption during hospitalization
The total opioid consumption during hospitalization is calculated in morphine equivalents. Opioid doses will first be converted to morphine equivalents and then expressed as oral morphine equivalents (OME).
Measured: On the day patient is discharged from hospital, for an average of 1-2 days
Type of chronic analgesia
Type of chronic analgesia used at the 3- and 6-month telephone follow-up (e.g., type and dosage of medication, transcutaneous electrical nerve stimulation (TENS), relaxation, distraction, acupuncture, and physiotherapy).
Measured: 3 and 6 months after surgery
Presence of dysesthesia
Abnormal skin sensitivity at the surgical site at the 3- and 6-month telephone follow-up
Measured: 3 and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start5 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Moore, MD, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184463
- Sponsor's protocol ID
- 2026-13077
- Status last verified
- Feb 2026
- First submitted
- 12 Sep 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain After Thoracic Surgery: Towards a New Standard? A Comparative Prospective Study of Pain Reduction After Pulmonary Resection by RATS-TT, RATS-OTC, and Hybrid RATS.
- ClinicalTrials.gov ID
- NCT07184463
- Acronym / sponsor ID
- 2026-13077
- Keywords
- chronic pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 19 Sep 2025 (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.
Pulmonary resections are key in treating lung neoplasms, with techniques adapted to tumor size and location. Minimally invasive approaches like VATS have replaced open thoracotomy, but intercostal trocar placement can lead to nerve injury and chronic pain.
Robotic-assisted thoracic surgery (RATS) is usually done via a transthoracic (RATS-TT) approach using intercostal trocars. A newer "out of cage" method (RATS-OTC), using subcostal or subxiphoid ports, avoids intercostal access, potentially reducing nerve damage. A French study showed less opioid use and acute pain with RATS-OTC, but chronic pain outcomes are still unknown.
At CHUM, a hybrid RATS technique (RATS-TTH) is also used-intercostal for instruments, but with out-of-cage specimen extraction-to limit intercostal trauma.
Detailed description
Pulmonary resections play a crucial role in the treatment of lung neoplasms, with procedures tailored to the size and location of the tumors. The minimally invasive approach, particularly via video-assisted thoracoscopic surgery (VATS), has replaced traditional thoracotomy by allowing access to the thoracic cavity through surgical trocars inserted between the ribs. However, these trocars, placed near the intercostal nerves, can cause nerve injury and chronic pain.
Robotic-assisted thoracic surgery (RATS) is typically performed via a transthoracic approach (RATS-TT), using intercostal trocars similar to those in VATS. Recently, a robotic approach known as "out of cage" (RATS-OTC) has been described, which involves the use of subcostal or subxiphoid trocar insertion. This method avoids the passage of instruments through the intercostal space, thus theoretically eliminating the risk of intercostal nerve injury. Compared to the transthoracic approach, a French team reported a reduction in opioid use and decreased intensity of acute postoperative pain with the RATS-OTC approach. However, due to the novelty of this technique, chronic pain outcomes have yet to be compared with those observed in RATS-TT or VATS.
At the CHUM, a modified transthoracic RATS technique-called the hybrid approach (RATS-TTH)-is also used. In this method, trocars are placed intercostally, but the extraction of large pulmonary specimens is performed through an out-of-cage route to minimize potential intercostal trauma related to specimen removal. Pain associated with this approach has also not been described in the literature.
Postoperative pain significantly affects recovery and long-term quality of life. Although the VATS approach reduces the severity of acute pain, chronic pain remains common and impactful. In fact, in the CRYO-VATS study conducted at CHUM between 2023 and 2025, the incidence of chronic pain following pulmonary resection via VATS (without cryoanalgesia) was 30% at 3 months and 17.5% at 6 months.
The aim of this study is to describe the incidence of chronic pain at 3 and 6 months for the three surgical approaches used at CHUM:
RATS-OTC (robotic, completely spares the intercostal space),
RATS-TT (robotic, intercostal passage of instruments and pulmonary specimen),
RATS-TTH (robotic, hybrid technique with intercostal instrument passage but out-of-cage extraction of the pulmonary specimen).
The investigators hypothesize that the RATS-OTC approach will reduce the incidence of chronic pain by completely eliminating intercostal trauma. Currently, no study has reported on chronic pain outcomes comparing the RATS-TTH and RATS-OTC approaches. Simultaneous data collection from patients undergoing RATS-TT will serve as a comparison baseline. These preliminary data will provide the foundation for a randomized controlled trial to validate the potential chronic pain benefits of these innovative surgical approaches.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary resections surgery with three surgical approaches: | – | Other: Evaluation of chronic pain at 3 and 6 months after thoracic surgeryRATS-OTC (no intercostal access) RATS-TT (intercostal instruments and specimen) RATS-TTH (intercostal instruments, out-of-cage specimen) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective anatomical pulmonary resection (anatomical segmentectomy, lobectomy or bilobectomy) via minimally invasive approach (robotic).
Key inclusion criteria (2 listed)
- Patients aged 18 years and older
- American Society of Anesthesiologists (ASA) score 1-3
Key exclusion criteria (3 listed)
- Language barrier, psychiatric, physical or mental condition making pain assessment impossible despite prior education
- Patient refusal to participate
- Patients reoperated by VATS or thoracotomy in the postoperative period in the context of the occurrence of complications
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 |
|---|---|---|
| Evaluation of chronic pain at 3 and 6 months after thoracic surgeryThe presence of persistent postoperative pain, defined as ipsilateral chest pain (on the same side as the surgery) occurring at rest and/or with coughing on a daily basis. Assessed by a 'yes' or 'no' response when asked at 3 and 6 months postoperatively. | Other | Pulmonary resections surgery with three surgical approaches: |
Primary outcome
Presence of persistent postoperative pain
Time frame: 3 and 6 months after surgery
The presence of persistent postoperative pain, defined as ipsilateral chest pain (on the same side as the surgery) occurring at rest and/or with coughing on a daily basis. Assessed by a 'yes' or 'no' response when asked at 3 and 6 months postoperatively.
9 secondary outcomes
Occurrence of a neuropathic pain component
Time frame: 3 and 6 months after surgery
Impact of chronic pain on overall recovery
Time frame: 3 and 6 months after surgery
Preoperative analgesic use
Time frame: On the day of the surgery
Overall recovery
Time frame: 3 and 6 months after surgery
Residual pain intensity
Time frame: 3 and 6 months after surgery
Total length of hospital stay
Time frame: On the day patient is discharged from hospital, up to two weeks
Total opioid consumption during hospitalization
Time frame: On the day patient is discharged from hospital, for an average of 1-2 days
Type of chronic analgesia
Time frame: 3 and 6 months after surgery
Presence of dysesthesia
Time frame: 3 and 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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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.
Alex Moore, MD principal investigator
CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery and Video-assisted Thoracic Surgery, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 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: looking for participants now, as of the sponsor's last update on 23 Feb 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex Moore, MD (514-890-8000 ext. 12132, alex.moore.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of persistent postoperative pain (time frame: 3 and 6 months after surgery). 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 23 Feb 2026.