Perioperative Quantitative Sensory Testing and Incision Pain Mapping in Thoracic Surgery

NCT07653932 | Not Yet Recruiting DMC

• 1 other identifier: TJ-IRB202605020
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain; Chronic Postsurgical Pain; Thoracic Surgery; Lung Resection; Mechanical Hyperalgesia; Central Sensitization

Keywords

Quantitative sensory testing; QST; Incision pain mapping; Thoracoscopic surgery; Perioperative pain phenotype

Outcome Measures

Primary Outcomes (8)

• Recruitment Rate

  Proportion of eligible patients who provide written informed consent and are enrolled in the study.

  Baseline

• Completion Rate of Baseline Quantitative Sensory Testing

  Proportion of enrolled participants who complete the planned baseline QST assessment before surgery.

  Preoperative period, 1 to 3 days 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.

  48 to 72 hours after surgery

• Completion Rate of 1-month Follow-up

  Proportion of enrolled participants who complete the planned 1-month postoperative follow-up assessment.

  1 month after surgery

• Completion Rate of 3-month Pain Outcome Follow-up

  Proportion of enrolled participants who complete the primary 3-month postoperative pain outcome assessment.

  90 ± 14 days after surgery

• QST-related Discontinuation Rate

  Proportion of participants who discontinue QST or pain mapping prematurely because of pain intolerance, fatigue, anxiety, or other participant-related reasons.

  From baseline assessment to 3 months after surgery

• Study-related Adverse Event Rate

  Proportion of participants with study-related adverse events, including marked discomfort, transient pain exacerbation, local discomfort related to QST or pain mapping, or adverse events related to blood sampling.

  From baseline assessment to 3 months after surgery

• Data Completeness of Key Study Variables

  Proportion of missing data for key variables

  From baseline assessment to 3 months after surgery

Secondary Outcomes (19)

• Movement-related Pain Intensity During the First 72 Hours After Surgery

  1, 6, 12, 18, 24, 32, 40, 48, 60, and 72 hours after surgery

• Resting Pain Intensity During the First 72 Hours After Surgery

  1, 6, 12, 18, 24, 32, 40, 48, 60, and 72 hours after surgery

• Area of Peri-incisional Mechanical Hyperalgesia

  48 to 72 hours after surgery

• Area Under the Curve of Resting Pain Scores

  0 to 72 hours after surgery

• Area Under the Curve of Movement-related Pain Scores

  0 to 72 hours after surgery

Other Outcomes (2)

• Psychological Factors and Postoperative Pain

  Baseline to 3 months after surgery

• Blood-based Inflammatory or Plasma Biomarkers

  Baseline, 48 ± 12 hours after surgery, before discharge, 1 month, and 90 ± 14 days after surgery when feasible

Study Arms (1)

Elective Thoracoscopic or Robotic-assisted Lung Resection Cohort

Adult patients scheduled for elective thoracoscopic or robotic-assisted lung resection will be enrolled and followed prospectively from the preoperative period to 3 months after surgery. Participants will undergo observational assessments including questionnaires, quantitative sensory testing, peri-incisional mechanical hyperalgesia pain mapping, serial postoperative pain assessments, analgesic exposure recording, and exploratory blood sampling. No therapeutic intervention will be assigned by the investigators.

Other: Perioperative QST and incision pain mapping assessment

Interventions

Perioperative QST and incision pain mapping assessment OTHER

Participants 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.

Elective Thoracoscopic or Robotic-assisted Lung Resection Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• Willing to undergo QST assessment, perioperative venous blood sampling, and postoperative follow-up.
• Able and willing to provide written informed consent.

You may not qualify if:

• 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.
• \. Definite painful neuropathic disease or long-term use of opioids or other analgesics for more than 2 weeks.
• \. Peripheral neuropathy, spinal cord disease, or other neurological disease that may substantially interfere with interpretation of QST results.
• \. Severe cognitive impairment, psychiatric disorder, communication disorder, or inability to complete questionnaires and QST assessments.
• \. Active infection, active autoimmune disease, or other disease condition that may substantially affect inflammatory protein measurements.
• \. Emergency surgery, conversion to open thoracotomy, extensive chest wall resection, or severe intraoperative complications.
• \. Any condition that, in the opinion of the investigator, makes the participant unsuitable for continued participation in the study.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Pain, Postoperative; Hyperalgesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Central Study Contacts

Ni Zhang, Dr

CONTACT

8613871288490; nizhang@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 17, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

CN (1)