An observational study in Postoperative Pain, Chronic Postsurgical Pain and Thoracic Surgery, sponsored by Tongji Hospital. Not yet recruiting at 1 site in China. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Tongji Hospital · Observational
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.
This is a single-center, prospective, observational pilot cohort study conducted in adult patients scheduled to undergo elective thoracoscopic or robotic-assisted lung resection. The study is designed to characterize perioperative pain phenotypes using standardized quantitative sensory testing (QST), incision-centered mechanical hyperalgesia pain mapping, serial pain intensity assessments, analgesic exposure, psychological and sleep-related questionnaires, and exploratory inflammatory or plasma biomarker measurements.
Eligible participants will provide written informed consent before surgery. Baseline assessments will be performed 1-3 days before surgery and will include demographic and clinical data collection, baseline pain history, psychological and sleep-related questionnaires, preoperative QST, and blood sampling. QST will assess sensory function in the surgical-side thoracic region, contralateral mirror region, and a remote control site where applicable.
During the first 72 hours after surgery, resting and movement-related numeric rating scale pain scores will be collected at prespecified time points, together with perioperative anesthetic, regional block, surgical, analgesic, and recovery-related information. Opioid consumption will be converted to morphine milligram equivalents.
At 48-72 hours after surgery, participants will undergo core postoperative QST and incision-centered mechanical pain mapping. The pain map will be generated around the incision or main port site in eight radial directions. Standardized mechanical stimulation will be applied from normal surrounding skin toward the incision, and boundary points will be marked when the participant reports a transition from normal sensation to increased pain, sharpness, burning, or abnormal discomfort. These boundary points will be connected to estimate the area of mechanical hyperalgesia.
Additional assessments will be performed before discharge, at 1 month, and at 90 ± 14 days after surgery. Follow-up assessments will evaluate persistent pain, pain intensity, pain interference, neuropathic pain features, QST changes, pain-map characteristics, quality of recovery, and exploratory blood biomarkers. Chronic postsurgical pain will be assessed at 3 months after surgery and defined as new or worsened pain related to the surgical area, persisting for at least 3 months after surgery, and not better explained by other causes.
The study will not assign any therapeutic intervention. Surgical technique, anesthetic management, regional analgesia, postoperative analgesia, chest tube management, and perioperative care will follow routine clinical practice. Key perioperative variables will be prospectively collected and considered as potential confounders in statistical analyses.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 46 is below the median of 102 across 683 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Tongji Hospital is the lead sponsor of 386 studies on the registry; 209 are open to participants now.
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Adult patients scheduled to undergo elective thoracoscopic or robotic-assisted lung resection at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Recruitment Rate
Proportion of eligible patients who provide written informed consent and are enrolled in the study.
Time frame: Baseline
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
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
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
Completion Rate of 3-month Pain Outcome Follow-up
Proportion of enrolled participants who complete the primary 3-month postoperative pain outcome assessment.
Time frame: 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.
Time frame: 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.
Time frame: From baseline assessment to 3 months after surgery
Data Completeness of Key Study Variables
Proportion of missing data for key variables
Time frame: From baseline assessment to 3 months after surgery
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
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
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
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
Area Under the Curve of Movement-related Pain Scores
Cumulative movement-related pain burden calculated as the area under the curve of serial movement-related Numeric Rating Scale pain scores during the first 72 postoperative hours
Time frame: 0 to 72 hours after surgery
Cumulative Opioid Consumption
Total postoperative opioid consumption during the first 72 hours after surgery, converted to morphine milligram equivalents.
Time frame: 0 to 72 hours after surgery
Quality of Recovery-15 Score
Postoperative recovery quality assessed using the 15-item Quality of Recovery questionnaire. Higher scores indicate better recovery.
Time frame: 72 hours after surgery and before discharge
Analgesia-related Adverse Effects
Incidence of analgesia-related adverse effects, including postoperative nausea and vomiting, excessive sedation, dizziness, or other analgesia-related symptoms.
Time frame: 0 to 72 hours after surgery
Time to First Ambulation
Time from the end of surgery to the first documented postoperative ambulation.
Time frame: Perioperative
Chest Tube Duration
Duration of postoperative chest tube drainage, measured in hours or days.
Time frame: Perioperative
Postoperative Length of Hospital Stay
Number of days from surgery to hospital discharge.
Time frame: Perioperative
Perioperative Complications
Incidence of perioperative complications recorded during hospitalization
Time frame: Perioperative
Change in Quantitative Sensory Testing Parameters
Changes in QST parameters measured at the surgical-side thoracic region, contralateral mirror region, and remote control site when applicable.
Time frame: Baseline, 48 to 72 hours after surgery, 1 month after surgery, and 90 ± 14 days after surgery
Maximum Radius of Peri-incisional Pain Map
Maximum radial distance from the incision or main port site to the boundary of mechanical hyperalgesia.
Time frame: 48 to 72 hours after surgery, 1 month after surgery, and 90 ± 14 days after surgery
Minimum Radius of Peri-incisional Pain Map
Minimum radial distance from the incision or main port site to the boundary of mechanical hyperalgesia.
Time frame: 48 to 72 hours after surgery, 1 month after surgery, and 90 ± 14 days after surgery
Incidence of Persistent Pain at 1 Month
Proportion of participants reporting pain related to the surgical area at 1 month after surgery.
Time frame: 1 month after surgery
Incidence of Chronic Postsurgical Pain at 3 Months
Proportion of participants with new or worsened pain related to the surgical area persisting at 3 months after surgery and not better explained by other causes.
Time frame: 90 ± 14 days after surgery
Pain Interference at 3 Months
Pain-related interference with daily activity, sleep, and function assessed using the Brief Pain Inventory-short form.
Time frame: 90 ± 14 days after surgery
Neuropathic Pain Features at 3 Months
Neuropathic pain symptoms, such as numbness, burning pain, electric shock-like pain, or touch-evoked pain, assessed using the DN4 questionnaire and symptom interview.
Time frame: 90 ± 14 days after surgery
Psychological Factors and Postoperative Pain
Association of baseline psychological factors
Time frame: Baseline to 3 months after surgery
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
Plan to share: Undecided
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