Oliceridine
Drugpostoperative patient-controlled analgesia (PCA)
NCT Number: NCT07018375
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 4
The No. 2 Hospital of Baoding, Baoding, Hebei, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
postoperative patient-controlled analgesia (PCA)
Sufentanil
Time frame: 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.
Time frame: 24h and 48h after surgery
Acute pain NRS score at 24 and 48 hours after surgery
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0-48h postoperatively, 1 month postoperatively, 3 months postoperatively
Dose and frequency of rescue analgesics
Time frame: 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.
Time frame: 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.
Time frame: 1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively
By the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively
By Hospital Anxiety and Depression Scale(HADS)
Time frame: 1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively
By the Pain Catastrophizing Scale (PCS)
Time frame: 1 day preoperatively(baseline), 3 months postoperatively
The 36-Item Short Form Survey (SF-36)
Contact information is provided by the study sponsor or research team.
Yang Jiao, Doctor
CONTACT
Yonghao Yu, Doctor
CONTACT
Tianjin Medical University General Hospital
Other
Effect of Oliceridine-based Intravenous Patient-Controlled Analgesia on Chronic Postsurgical Pain After Video-Assisted Thoracoscopic Lung Resection: A Multicenter Randomized Double-Blind Controlled Trial Protocol
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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