Perioperative Quantitative Sensory Testing and Incision Pain Mapping in Thoracic Surgery
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Ni Zhang, Dr
- 電話番号：8613871288490
- メール：nizhang@tjh.tjmu.edu.cn
研究場所
-
-
Hubei
-
Wuhan、Hubei、中国、430030
- Tongji Hospital
-
コンタクト：
- Wei Ping, Dr.
- 電話番号：8613437101581
- メール：pingwei@tjh.tjmu.edu.cn
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recruitment Rate
時間枠：Baseline
|
Proportion of eligible patients who provide written informed consent and are enrolled in the study.
|
Baseline
|
|
Completion Rate of Baseline Quantitative Sensory Testing
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：From baseline assessment to 3 months after surgery
|
Proportion of missing data for key variables
|
From baseline assessment to 3 months after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Movement-related Pain Intensity During the First 72 Hours After Surgery
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Perioperative
|
Time from the end of surgery to the first documented postoperative ambulation.
|
Perioperative
|
|
Chest Tube Duration
時間枠：Perioperative
|
Duration of postoperative chest tube drainage, measured in hours or days.
|
Perioperative
|
|
Postoperative Length of Hospital Stay
時間枠：Perioperative
|
Number of days from surgery to hospital discharge.
|
Perioperative
|
|
Perioperative Complications
時間枠：Perioperative
|
Incidence of perioperative complications recorded during hospitalization
|
Perioperative
|
|
Change in Quantitative Sensory Testing Parameters
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Psychological Factors and Postoperative Pain
時間枠：Baseline to 3 months after surgery
|
Association of baseline psychological factors
|
Baseline to 3 months after surgery
|
|
Blood-based Inflammatory or Plasma Biomarkers
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- TJ-IRB202605020
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。