Chronic Postsurgical Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGOliceridine
postoperative patient-controlled analgesia (PCA)
DRUGSufentanil
Sufentanil
Sponsors
Tianjin Medical University General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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; * Expected postoperative recovery in the general ward setting.
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); * Any condition deemed unsuitable for study participation by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of chronic pain after surgery | from day 1 to day 90 after surgery | Chronic pain intensity was assessed by a numeric rating scale (NRS) using a telephone questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 48 hours after surgery | — |
| Chronic pain NRS score 3 months after surgery | 3 months postoperatively | assessed by NRS scale |
| Neuropathic pain (DN4 score ≥ 4) | 1 day preoperatively；3 months postoperatively | the DN4 questionnaire is a brief and user-friendly screening tool designed to identify the presence of neuropathic pain components |
| Sleep quality assessment | 1 day preoperatively；3 months postoperatively | By Pittsburgh Sleep Index (PSQI) scale |
| postoperative acute pain NRS scoring | 24h and 48h after surgery | Acute pain NRS score (rest versus cough) at 24 and 48 hours after surgery |
| Evaluate pain catastrophizing levels in surgical patients | 1 day preoperatively；3 months postoperatively | By PCS Scale |
| Quality of Life Assessments | 1 day preoperatively；3 months postoperatively | The 36-Item Short Form Survey (SF-36) |
| Use and frequency of rescue analgesic administration | 1 day preoperatively；3 months postoperatively | Dose and frequency of rescue analgesics |
| Psychological status assessment | 1 day preoperatively； 3 months postoperatively | By Hamilton Anxiety/Depression Rating Scale (HAMA/HADS) |
Contacts
Primary ContactYang Jiao, Doctor
Backup ContactYonghao Yu, Doctor
Outcome results
None listed