A Study of Pain Reduction After Pulmonary Resection by RATS-TT, RATS-OTC, and Hybrid RATS.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years and older
American Society of Anesthesiologists (ASA) score 1-3
Disqualifiers
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 population
Patients undergoing elective anatomical pulmonary resection (anatomical segmentectomy, lobectomy or bilobectomy) via minimally invasive approach (robotic).
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Evaluation of chronic pain at 3 and 6 months after thoracic surgery
Other interventionThe 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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Pulmonary resections surgery with three surgical approaches:1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 and 6 months after surgerySecondary outcomes
1
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.
Time frame
3 and 6 months after surgery2
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.
Time frame
3 and 6 months after surgery3
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.
Time frame
On the day of the surgery4
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.
Time frame
3 and 6 months after surgerySponsors and contacts
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Source ClinicalTrials.gov