About this trial
Postoperative pain remains a common and clinically important burden after thoracic surgery and may progress to chronic postsurgical pain. Conventional pain assessment mainly relies on patient-reported pain intensity and analgesic consumption, which may not fully capture peri-incisional sensory abnormalities, mechanical hyperalgesia, or central sensitization.
This prospective observational pilot cohort study aims to evaluate the feasibility and acceptability of perioperative quantitative sensory testing (QST) and incision pain mapping in adult patients undergoing elective thoracoscopic or robotic-assisted lung resection. Participants will undergo baseline assessment before surgery, serial postoperative pain assessments during the first 72 hours, QST and mechanical hyperalgesia pain mapping at 48-72 hours after surgery, and follow-up assessments at discharge, 1 month, and 3 months after surgery.
The primary feasibility outcomes include recruitment rate, QST completion rates, follow-up completion rates, QST-related discontinuation rate, study-related adverse events, and data completeness. The main clinical mechanistic outcome is the area of peri-incisional mechanical hyperalgesia at 48-72 hours after surgery. Secondary outcomes include acute postoperative pain intensity, pain burden over 72 hours, opioid consumption, quality of recovery, QST changes, pain-map characteristics, and chronic postsurgical pain at 3 months.
This study will not assign or modify therapeutic interventions. All anesthetic, surgical, and analgesic management will be determined by the routine clinical care team. The study is expected to provide feasibility data, preliminary effect estimates, and mechanistic information for future larger perioperative pain studies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male
Scheduled to undergo elective thoracoscopic or robotic-assisted lung resection.
American Society of Anesthesiologists physical status I to III.
Able to understand and communicate adequately and to complete study questionnaires independently or with assistance from study staff.
Disqualifiers
Definite chronic chest wall, shoulder, back, or upper limb pain with an average 2. Numeric Rating Scale score of 3 or higher during the preceding week.
Trial population
Adult patients scheduled to undergo elective thoracoscopic or robotic-assisted lung resection at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial design
Cohort
Prospective
Treatments tested in this trial
Perioperative QST and incision pain mapping assessment
Other interventionParticipants will undergo non-invasive perioperative quantitative sensory testing and incision-centered mechanical pain mapping at prespecified time points. These assessments are observational and will not determine or modify clinical anesthesia, analgesia, or surgical management.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment Rate
Proportion of eligible patients who provide written informed consent and are enrolled in the study.
Completion Rate of Baseline Quantitative Sensory Testing
Proportion of enrolled participants who complete the planned baseline QST assessment before surgery.
Completion Rate of Postoperative QST and Incision Pain Mapping
Proportion of enrolled participants who complete the core postoperative QST assessment and incision-centered mechanical hyperalgesia pain mapping.
Completion Rate of 1-month Follow-up
Proportion of enrolled participants who complete the planned 1-month postoperative follow-up assessment.
Secondary outcomes
Movement-related Pain Intensity During the First 72 Hours After Surgery
Movement-related pain intensity measured using an 11-point Numeric Rating Scale during turning in bed or active mobilization, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Resting Pain Intensity During the First 72 Hours After Surgery
Resting pain intensity measured using an 11-point Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Area of Peri-incisional Mechanical Hyperalgesia
Area of mechanical hyperalgesia around the surgical incision or main port site, measured in square centimeters using standardized incision-centered mechanical pain mapping.
Area Under the Curve of Resting Pain Scores
Cumulative resting pain burden calculated as the area under the curve of serial resting Numeric Rating Scale pain scores during the first 72 postoperative hours.
Other outcomes
Psychological Factors and Postoperative Pain
Association of baseline psychological factors
Blood-based Inflammatory or Plasma Biomarkers
Exploratory changes in inflammatory markers
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: