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Perioperative Quantitative Sensory Testing and Incision Pain Mapping in Thoracic Surgery

13. června 2026 aktualizováno: Zhang Ni, Tongji Hospital

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.

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

46

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Čína
    • Hubei
      • Wuhan, Hubei, Čína, 430030

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Adult patients scheduled to undergo elective thoracoscopic or robotic-assisted lung resection at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.

Popis

Inclusion Criteria:

  1. Male
  2. Scheduled to undergo elective thoracoscopic or robotic-assisted lung resection.
  3. American Society of Anesthesiologists physical status I to III.
  4. Able to understand and communicate adequately and to complete study questionnaires independently or with assistance from study staff.
  5. Willing to undergo QST assessment, perioperative venous blood sampling, and postoperative follow-up.
  6. Able and willing to provide written informed consent.

Exclusion Criteria:

  1. 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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Recruitment Rate
Časové okno: Baseline
Proportion of eligible patients who provide written informed consent and are enrolled in the study.
Baseline
Completion Rate of Baseline Quantitative Sensory Testing
Časové okno: Preoperative period, 1 to 3 days before surgery
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
Časové okno: 48 to 72 hours after surgery
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
Časové okno: 1 month after surgery
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
Časové okno: 90 ± 14 days after surgery
Proportion of enrolled participants who complete the primary 3-month postoperative pain outcome assessment.
90 ± 14 days after surgery
QST-related Discontinuation Rate
Časové okno: 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.
From baseline assessment to 3 months after surgery
Study-related Adverse Event Rate
Časové okno: 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.
From baseline assessment to 3 months after surgery
Data Completeness of Key Study Variables
Časové okno: From baseline assessment to 3 months after surgery
Proportion of missing data for key variables
From baseline assessment to 3 months after surgery

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Movement-related Pain Intensity During the First 72 Hours After Surgery
Časové okno: 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.
1, 6, 12, 18, 24, 32, 40, 48, 60, and 72 hours after surgery
Resting Pain Intensity During the First 72 Hours After Surgery
Časové okno: 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.
1, 6, 12, 18, 24, 32, 40, 48, 60, and 72 hours after surgery
Area of Peri-incisional Mechanical Hyperalgesia
Časové okno: 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.
48 to 72 hours after surgery
Area Under the Curve of Resting Pain Scores
Časové okno: 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.
0 to 72 hours after surgery
Area Under the Curve of Movement-related Pain Scores
Časové okno: 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
0 to 72 hours after surgery
Cumulative Opioid Consumption
Časové okno: 0 to 72 hours after surgery
Total postoperative opioid consumption during the first 72 hours after surgery, converted to morphine milligram equivalents.
0 to 72 hours after surgery
Quality of Recovery-15 Score
Časové okno: 72 hours after surgery and before discharge
Postoperative recovery quality assessed using the 15-item Quality of Recovery questionnaire. Higher scores indicate better recovery.
72 hours after surgery and before discharge
Analgesia-related Adverse Effects
Časové okno: 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.
0 to 72 hours after surgery
Time to First Ambulation
Časové okno: Perioperative
Time from the end of surgery to the first documented postoperative ambulation.
Perioperative
Chest Tube Duration
Časové okno: Perioperative
Duration of postoperative chest tube drainage, measured in hours or days.
Perioperative
Postoperative Length of Hospital Stay
Časové okno: Perioperative
Number of days from surgery to hospital discharge.
Perioperative
Perioperative Complications
Časové okno: Perioperative
Incidence of perioperative complications recorded during hospitalization
Perioperative
Change in Quantitative Sensory Testing Parameters
Časové okno: 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.
Baseline, 48 to 72 hours after surgery, 1 month after surgery, and 90 ± 14 days after surgery
Maximum Radius of Peri-incisional Pain Map
Časové okno: 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.
48 to 72 hours after surgery, 1 month after surgery, and 90 ± 14 days after surgery
Minimum Radius of Peri-incisional Pain Map
Časové okno: 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.
48 to 72 hours after surgery, 1 month after surgery, and 90 ± 14 days after surgery
Incidence of Persistent Pain at 1 Month
Časové okno: 1 month after surgery
Proportion of participants reporting pain related to the surgical area at 1 month after surgery.
1 month after surgery
Incidence of Chronic Postsurgical Pain at 3 Months
Časové okno: 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.
90 ± 14 days after surgery
Pain Interference at 3 Months
Časové okno: 90 ± 14 days after surgery
Pain-related interference with daily activity, sleep, and function assessed using the Brief Pain Inventory-short form.
90 ± 14 days after surgery
Neuropathic Pain Features at 3 Months
Časové okno: 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.
90 ± 14 days after surgery

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Psychological Factors and Postoperative Pain
Časové okno: Baseline to 3 months after surgery
Association of baseline psychological factors
Baseline to 3 months after surgery
Blood-based Inflammatory or Plasma Biomarkers
Časové okno: Baseline, 48 ± 12 hours after surgery, before discharge, 1 month, and 90 ± 14 days after surgery when feasible
Exploratory changes in inflammatory markers
Baseline, 48 ± 12 hours after surgery, before discharge, 1 month, and 90 ± 14 days after surgery when feasible

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Tongji Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

8. června 2026

Primární dokončení (Odhadovaný)

31. prosince 2026

Dokončení studie (Odhadovaný)

28. února 2027

Termíny zápisu do studia

První předloženo

3. června 2026

První předloženo, které splnilo kritéria kontroly kvality

13. června 2026

První zveřejněno (Aktuální)

17. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

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Studuje produkt zařízení regulovaný americkým úřadem FDA

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