Chronic Postsurgical Pain
Conditions
Keywords
oliceridine, sufentanil, chronic postsurgical pain, VATS, patient-controlled analgesia
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) with functional impact in patients undergoing video-assisted thoracoscopic surgery.
Detailed description
The primary objective is to evaluate the impact of oliceridine versus sufentanil administered via patient controlled intravenous analgesia (PCIA) for perioperative analgesia on the incidence of chronic postsurgical pain (CPSP) with functional impact in patients undergoing video-assisted thoracoscopic surgery. This is a multicentre, randomised, double-blind, controlled trial enrolling 320 patients across seven Chinese tertiary centres.
Interventions
DRUGOliceridine
postoperative patient-controlled analgesia (PCA)
DRUGSufentanil
Sufentanil
Sponsors
Tianjin Medical University General Hospital
The No. 2 Hospital of Baoding
Tianjin Cancer Hospital Airport Hospital
Tianjin Medical University Second Hospital
North China University of Science and Technology
Haibin People's Hospital of Tianjin Binhai New Area
The People's Hospital of Jizhou District, Tianjin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years * ASA physical status I-III * BMI 18-35 kg/m² * Scheduled for unilateral video-assisted thoracoscopic surgery (VATS) lung resection, including wedge resection, segmentectomy, lobectomy, or radical resection for lung cancerresection for lung cancer * Preoperative Numeric Rating Scale (NRS) pain score of 0 * Ability to understand the study objectives and procedures, with voluntary informed consent obtained * Expected postoperative recovery in the general ward setting
Exclusion criteria
* 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/1.73 m²) * Severe or unstable psychiatric disorders requiring psychoactive medication (e.g., schizophrenia, bipolar disorder), or cognitive impairment precluding reliable self-report * Other concurrent active malignancy or active infection * Known hypersensitivity to study medications (opioids, adjuvant analgesics, anesthetics, or antiemetics) * Pregnancy, lactation, or planned pregnancy during the study period * Participation in another interventional clinical trial within 3 months before enrolment * Any condition deemed unsuitable for study participation by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of chronic postsurgical pain with functional impact at 3 months after surgery | At 3 months after surgery (assessment window: postoperative day 90 +/- 14 days) | CPSP is a composite binary endpoint, positive only when all three criteria are met: (1) pain related to thoracoscopic surgery, confirmed by the scripted question "Do you currently have persisting pain related to your thoracoscopic surgery?", localized to the surgical site or a referred area, present for at least 3 months, and not attributable to other causes (local infection, tumour recurrence, or a new surgical or medical condition); (2) average numeric rating scale (NRS) pain score \>= 1 (0-10) at the surgical site during the week preceding the assessment; and (3) pain-related functional interference, defined as a pain interference score \>= 1 on the Brief Pain Inventory-Short Form (validated Chinese version), calculated as the mean of 7 interference items (each 0-10; prorated mean if at least 4 of 7 items are completed), with a 1-week recall period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use and frequency of rescue analgesic administration | 0-48h postoperatively, 1 month postoperatively, 3 months postoperatively | Dose and frequency of rescue analgesics |
| Brief Pain Inventory-Short Form (BPI-SF) pain severity and pain interference scores | 1 month postoperatively, 3 months postoperatively | BPI-SF pain severity (mean of 4 items) and pain interference (mean of 7 items) scores, each 0-10, administered by face-to-face interview or structured telephone interview with a 1-week recall period. |
| Postoperative acute pain NRS score | 24h and 48h after surgery | Acute pain intensity at 24 and 48 hours after surgery, measured by the Numeric Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse outcomes (greater pain intensity). |
| Quality of Recovery-15 (QoR-15) score | 24h and 48h after surgery | The QoR-15 assesses postoperative recovery quality across 15 items (0-10 each; total 0-150), administered at the bedside. Higher scores indicate better recovery. |
| Cumulative PCA opioid consumption and bolus deliveries | 0-48 hours postoperatively | Total delivered volume of the study solution (mL) and number of bolus deliveries (attempted and successful) recorded by the PCA pump during the 48-hour intervention period. Delivered oliceridine and sufentanil doses will be derived from body weight-based concentrations. The cumulative 24-hour oliceridine dose will be documented against the 27 mg/day threshold specified in the prescribing information. |
| Incidence of opioid-related adverse events | 0-48 h postoperatively | Incidence of opioid-related adverse events (ORAEs) within 48 hours postoperatively, including: postoperative nausea and vomiting (PONV), respiratory depression (SpO₂ \<92% or respiratory rate \<8/min), pruritus, sedation (Ramsay Sedation Scale ≥4), and dizziness. |
| Sleep quality assessment | 1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively | Sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-rated questionnaire yielding a global score ranging from 0 to 21. Higher scores indicate worse outcomes (poorer sleep quality). |
| Psychological status assessment | 1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively | Anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report questionnaire with two 7-item subscales: the HADS-Anxiety subscale and the HADS-Depression subscale, each ranging from 0 to 21. Higher scores indicate worse outcomes (greater anxiety or depressive symptoms). |
| Pain catastrophizing level | 1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively | Pain catastrophizing assessed by the Pain Catastrophizing Scale (PCS), a 13-item self-report questionnaire with a total score ranging from 0 to 52. Higher scores indicate worse outcomes (higher levels of pain catastrophizing). |
| Quality of life assessment | 1 day preoperatively(baseline), 3 months postoperatively | Quality of life assessed by the 36-Item Short Form Health Survey (SF-36), which yields 8 domain scores, each transformed to a scale of 0 to 100. Higher scores indicate better outcomes (better health-related quality of life). |
| Incidence of neuropathic pain component (DN4i ≥ 4) | 1 month postoperatively, 3 months postoperatively | The 7-item interview version of the Douleur Neuropathique 4 questionnaire (DN4i, score range 0-7) administered by structured telephone interview. DN4i \>= 4 indicates the presence of neuropathic pain components. |
Countries
China
Contacts
CONTACTYang Jiao, Doctor
CONTACTYonghao Yu, Doctor
PRINCIPAL_INVESTIGATORYang Jiao, Doctor
Tianjin Medical University General Hospital
Outcome results
None listed