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The primary objective is to evaluate the impact of oliceridine versus sufentanil for perioperative analgesia on the incidence of chronic postsurgical pain (CPSP) in patients undergoing video-assisted thoracoscopic surgery.
The primary objective is to evaluate the impact of oliceridine administered via patient controlled analgesia device(PCA)versus sufentanil administered via PCA on the incidence of chronic postsurgical pain (CPSP) in patients undergoing video-assisted thoracoscopic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oliceridine group | Experimental | Administer a loading dose of 0.03 mg/kg intravenously 20-30 minutes before the end of surgery. Postoperative PCA pump configuration: 0.6 mg/kg oxycodone diluted with normal saline to a total volume of 100 mL, with a background infusion rate of 2 mL/h, PCA bolus dose of 0.5 mL per injection, lockout interval of 15 minutes, and treatment duration of 48 hours. |
|
| Sufentanil Group | Active Comparator | Administer a loading dose of 0.1 μg/kg intravenously 20-30 minutes before the end of surgery. Postoperative PCA pump configuration: 2 μg/kg sufentanil diluted with normal saline to a total volume of 100 mL, with a background infusion rate of 2 mL/h, PCA bolus dose of 0.5 mL per injection, lockout interval of 15 minutes, and treatment duration of 48 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oliceridine | Drug | postoperative patient-controlled analgesia (PCA) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of chronic pain after surgery | Chronic pain intensity was assessed by a numeric rating scale (NRS) using a telephone questionnaire | from day 1 to day 90 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative acute pain NRS scoring | Acute pain NRS score (rest versus cough) at 24 and 48 hours after surgery | 24h and 48h after surgery |
| Incidence of adverse events | 48 hours after surgery |
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Inclusion Criteria:
① Age 18-75 years, ASA physical status I-III, BMI 18-30 kg/m²;
Scheduled for unilateral video-assisted thoracoscopic surgery (VATS) lung resection, including wedge resection, segmentectomy, lobectomy, or radical resection for lung cancer;
Preoperative pain score <1 on the Numeric Rating Scale (NRS);
Ability to understand the study objectives and procedures, with voluntary informed consent obtained;
Exclusion Criteria:
① History of chronic pain or long-term analgesic use prior to surgery;
Previous ipsilateral thoracic surgery;
Prior neoadjuvant radiotherapy or chemotherapy;
Severe cardiovascular or cerebrovascular disease, or hepatic/renal dysfunction (ALT/AST >3× upper limit of normal; eGFR <60 mL/min/1.73m²);
Concurrent malignancy or active infection;
Pre-existing psychiatric disorders or communication barriers precluding study participation;
Known hypersensitivity to study medications (opioids, adjuvant analgesics, anesthetics, or antiemetics);
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| Name | Affiliation | Role |
|---|---|---|
| Yang Jiao, Doctor | Tianjin Medical University General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Tianjin | 300052 | China |
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| Sufentanil |
| Drug |
Sufentanil |
|
| Chronic pain NRS score 3 months after surgery | assessed by NRS scale | 3 months postoperatively |
| Neuropathic pain (DN4 score ≥ 4) | the DN4 questionnaire is a brief and user-friendly screening tool designed to identify the presence of neuropathic pain components | 1 day preoperatively;3 months postoperatively |
| Sleep quality assessment | By Pittsburgh Sleep Index (PSQI) scale | 1 day preoperatively;3 months postoperatively |
| Psychological status assessment | By Hamilton Anxiety/Depression Rating Scale (HAMA/HADS) | 1 day preoperatively; 3 months postoperatively |
| Evaluate pain catastrophizing levels in surgical patients | By PCS Scale | 1 day preoperatively;3 months postoperatively |
| Quality of Life Assessments | The 36-Item Short Form Survey (SF-36) | 1 day preoperatively;3 months postoperatively |
| Use and frequency of rescue analgesic administration | Dose and frequency of rescue analgesics | 1 day preoperatively;3 months postoperatively |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C586842 | ((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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