Tongji Hospital
Wuhan, Hubei, 430030, China
NCT Number: NCT07653932
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.
Trial opening soon.
Get Notified18 year and older
Male
Observational
Wuhan, Hubei, 430030, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline
Proportion of eligible patients who provide written informed consent and are enrolled in the study.
Time frame: Preoperative period, 1 to 3 days before surgery
Proportion of enrolled participants who complete the planned baseline QST assessment before surgery.
Time frame: 48 to 72 hours after surgery
Proportion of enrolled participants who complete the core postoperative QST assessment and incision-centered mechanical hyperalgesia pain mapping.
Time frame: 1 month after surgery
Proportion of enrolled participants who complete the planned 1-month postoperative follow-up assessment.
Time frame: 90 ± 14 days after surgery
Proportion of enrolled participants who complete the primary 3-month postoperative pain outcome assessment.
Time frame: From baseline assessment to 3 months after surgery
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
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
Proportion of missing data for key variables
Time frame: 1, 6, 12, 18, 24, 32, 40, 48, 60, and 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 measured using an 11-point Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Time frame: 48 to 72 hours after surgery
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: 0 to 72 hours after surgery
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
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
Total postoperative opioid consumption during the first 72 hours after surgery, converted to morphine milligram equivalents.
Time frame: 72 hours after surgery and before discharge
Postoperative recovery quality assessed using the 15-item Quality of Recovery questionnaire. Higher scores indicate better recovery.
Time frame: 0 to 72 hours after surgery
Incidence of analgesia-related adverse effects, including postoperative nausea and vomiting, excessive sedation, dizziness, or other analgesia-related symptoms.
Time frame: Perioperative
Time from the end of surgery to the first documented postoperative ambulation.
Time frame: Perioperative
Duration of postoperative chest tube drainage, measured in hours or days.
Time frame: Perioperative
Number of days from surgery to hospital discharge.
Time frame: Perioperative
Incidence of perioperative complications recorded during hospitalization
Time frame: Baseline, 48 to 72 hours after surgery, 1 month after surgery, and 90 ± 14 days after surgery
Changes in QST parameters measured at the surgical-side thoracic region, contralateral mirror region, and remote control site when applicable.
Time frame: 48 to 72 hours after surgery, 1 month after surgery, and 90 ± 14 days after surgery
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 radial distance from the incision or main port site to the boundary of mechanical hyperalgesia.
Time frame: 1 month after surgery
Proportion of participants reporting pain related to the surgical area at 1 month after surgery.
Time frame: 90 ± 14 days after surgery
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-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 symptoms, such as numbness, burning pain, electric shock-like pain, or touch-evoked pain, assessed using the DN4 questionnaire and symptom interview.
Time frame: Baseline to 3 months after surgery
Association of baseline psychological factors
Time frame: Baseline, 48 ± 12 hours after surgery, before discharge, 1 month, and 90 ± 14 days after surgery when feasible
Exploratory changes in inflammatory markers
Contact information is provided by the study sponsor or research team.
Tongji Hospital
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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