Perioperative Quantitative Sensory Testing and Incision Pain Mapping in Thoracic Surgery

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorTongji Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Perioperative QST and incision pain mapping assessment

    Other intervention

    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.

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: Elective Thoracoscopic or Robotic-assisted Lung Resection Cohort1 intervention

Trial outcomes

Primary outcomes

1

Recruitment Rate

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

Time frame
Baseline
2

Completion Rate of Baseline Quantitative Sensory Testing

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

Time frame
Preoperative period, 1 to 3 days before surgery
3

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.

Time frame
48 to 72 hours after surgery
4

Completion Rate of 1-month Follow-up

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

Time frame
1 month after surgery

Secondary outcomes

1

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.

Time frame
1, 6, 12, 18, 24, 32, 40, 48, 60, and 72 hours after surgery
2

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.

Time frame
1, 6, 12, 18, 24, 32, 40, 48, 60, and 72 hours after surgery
3

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.

Time frame
48 to 72 hours after surgery
4

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.

Time frame
0 to 72 hours after surgery

Other outcomes

1

Psychological Factors and Postoperative Pain

Association of baseline psychological factors

Time frame
Baseline to 3 months after surgery
2

Blood-based Inflammatory or Plasma Biomarkers

Exploratory changes in inflammatory markers

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

Sponsors and contacts

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