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Postoperative PainNCT07653932

Perioperative Quantitative Sensory Testing and Incision Pain Mapping in Thoracic Surgery

An observational study of Postoperative Pain and Chronic Postsurgical Pain, run by Tongji Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Perioperative QST and incision pain mapping assessment
How many people
46 participants
Where
1 siteChina
Study dates
8 Jun 2026to 28 Feb 2027
How long will I take part?
3 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Tongji Hospital

    Wuhan, Hubei, 430030

    Wei Ping, Dr., 8613437101581, pingwei@tjh.tjmu.edu.cn

Other trials in China

About this study

Official title: Perioperative Pain Phenotyping and Incision Pain Mapping Using Quantitative Sensory Testing in Patients Undergoing Thoracoscopic or Robotic-assisted Lung Resection: A Prospective Observational Pilot Cohort Study

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.

Read more

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.

Read the detailed description

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.

Being tested
Perioperative QST and incision pain mapping assessment
Keywords
Quantitative sensory testing, QST, Incision pain mapping, Thoracoscopic surgery, Perioperative pain phenotype
Medical subject headings
Pain, Postoperative, Hyperalgesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Perioperative QST and incision pain mapping assessmentOther

    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.

Study groups in NCT07653932
Study groupRoleWhat they receive
Elective Thoracoscopic or Robotic-assisted Lung Resection CohortAdult 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.
Receives: Other: Perioperative QST and incision pain mapping assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate

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

    Measured: Baseline

  2. Completion Rate of Baseline Quantitative Sensory Testing

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

    Measured: 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.

    Measured: 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.

    Measured: 1 month after surgery

  5. Completion Rate of 3-month Pain Outcome Follow-up

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

    Measured: 90 ± 14 days after surgery

  6. 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.

    Measured: From baseline assessment to 3 months after surgery

  7. 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.

    Measured: From baseline assessment to 3 months after surgery

  8. Data Completeness of Key Study Variables

    Proportion of missing data for key variables

    Measured: From baseline assessment to 3 months after surgery

Secondary outcomes (19)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 0 to 72 hours after surgery

  5. 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

    Measured: 0 to 72 hours after surgery

  6. Cumulative Opioid Consumption

    Total postoperative opioid consumption during the first 72 hours after surgery, converted to morphine milligram equivalents.

    Measured: 0 to 72 hours after surgery

  7. Quality of Recovery-15 Score

    Postoperative recovery quality assessed using the 15-item Quality of Recovery questionnaire. Higher scores indicate better recovery.

    Measured: 72 hours after surgery and before discharge

  8. Analgesia-related Adverse Effects

    Incidence of analgesia-related adverse effects, including postoperative nausea and vomiting, excessive sedation, dizziness, or other analgesia-related symptoms.

    Measured: 0 to 72 hours after surgery

  9. Time to First Ambulation

    Time from the end of surgery to the first documented postoperative ambulation.

    Measured: Perioperative

  10. Chest Tube Duration

    Duration of postoperative chest tube drainage, measured in hours or days.

    Measured: Perioperative

  11. Postoperative Length of Hospital Stay

    Number of days from surgery to hospital discharge.

    Measured: Perioperative

  12. Perioperative Complications

    Incidence of perioperative complications recorded during hospitalization

    Measured: Perioperative

  13. 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.

    Measured: Baseline, 48 to 72 hours after surgery, 1 month after surgery, and 90 ± 14 days after surgery

  14. Maximum Radius of Peri-incisional Pain Map

    Maximum radial distance from the incision or main port site to the boundary of mechanical hyperalgesia.

    Measured: 48 to 72 hours after surgery, 1 month after surgery, and 90 ± 14 days after surgery

  15. Minimum Radius of Peri-incisional Pain Map

    Minimum radial distance from the incision or main port site to the boundary of mechanical hyperalgesia.

    Measured: 48 to 72 hours after surgery, 1 month after surgery, and 90 ± 14 days after surgery

  16. Incidence of Persistent Pain at 1 Month

    Proportion of participants reporting pain related to the surgical area at 1 month after surgery.

    Measured: 1 month after surgery

  17. 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.

    Measured: 90 ± 14 days after surgery

  18. Pain Interference at 3 Months

    Pain-related interference with daily activity, sleep, and function assessed using the Brief Pain Inventory-short form.

    Measured: 90 ± 14 days after surgery

  19. 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.

    Measured: 90 ± 14 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start8 Jun 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
46 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07653932
Sponsor's protocol ID
TJ-IRB202605020
Status last verified
Jun 2026
First submitted
3 Jun 2026
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Pain and Chronic Postsurgical Pain, run by Tongji Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ni Zhang, Dr (8613871288490, nizhang@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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