← Back to all trials
Not Yet Recruiting
NCT07653932
Perioperative Quantitative Sensory Testing and Incision Pain Mapping in Thoracic Surgery
Conditions: Postoperative Pain, Chronic Postsurgical Pain, Thoracic Surgery, Lung Resection, Mechanical Hyperalgesia, Central Sensitization
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 46
Sponsor: Tongji Hospital
Location: Tongji Hospital Wuhan Hubei
Summary
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
Inclusion Criteria:
1. Male
2. Scheduled to undergo elective thoracoscopic or robotic-assisted lung resection.
3. American Society of Anesthesiologists physical status I to III.
4. Able to understand and communicate adequately and to complete study questionnaires independently or with assistance from study staff.
5. Willing to undergo QST assessment, perioperative venous blood sampling, and postoperative follow-up.
6. Able and willing to provide written informed consent.
Exclusion Criteria:
1. 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.
3\. Definite painful neuropathic disease or long-term use of opioids or other analgesics for more than 2 weeks.
4\. Peripheral neuropathy, spinal cord disease, or other neurological disease that may substantially interfere with interpretation of QST results.
5\. Severe cognitive impairment, psychiatric disorder, communication disorder, or inability to complete questionnaires and QST assessments.
6\. Active infection, active autoimmune disease, or other disease condition that may substantially affect inflammatory protein measurements.
7\. Emergency surgery, conversion to open thoracotomy, extensive chest wall resection, or severe intraoperative complications.
8\. Any condition that, in the opinion of the investigator, makes the participant unsuitable for continued participation in the study.
Source: ClinicalTrials.gov (NCT07653932). StuddyBuddy aggregates publicly available trial information.