Chronic Postsurgical PainPhase 4NCT07018375
Effect of Oliceridine Patient-Controlled Intravenous Analgesia on Postoperative Chronic Pain After Video-Assisted Thoracoscopic Lung Resection
A Phase 4 study testing Oliceridine and Sufentanil in people with Chronic Postsurgical Pain, run by Tianjin Medical University General Hospital at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Postsurgical Pain
- What is being tested?
- Oliceridine and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 7 sitesChina
- Study dates
- 6 Jan 2026to 30 Apr 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yonghao Yu, Doctor contact
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
The No. 2 Hospital of Baoding
Baoding, Hebei
Tianfang Qu, +86 15933938242
- Recruiting
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei
Shubo Zhang, +86 15383055768
- Recruiting
Tianjin Medical University General Hospital
Tianjin, 300052
Yang Jiao, +86 15900292506, jiaoxiuxiu1987@163.com
- Recruiting
Haibin People's Hospital of Tianjin Binhai New Area
Tianjin
Lifeng Lu, +86 18522593633
- Recruiting
The People's Hospital of Jizhou District, Tianjin
Tianjin
Hongying Mu, +86 18622657601
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin
Shuhui Xin, +86 15922074002
- Recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin
Yifu Tian, +86 18322473181
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Chronic Postsurgical Pain
- Being tested
- Oliceridine, Sufentanil
- Keywords
- oliceridine, sufentanil, chronic postsurgical pain, VATS, patient-controlled analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OliceridineDrug
postoperative patient-controlled analgesia (PCA)
SufentanilDrug
Sufentanil
| Study group | Role | What they receive |
|---|---|---|
| Oliceridine group | Experimental | Administer a loading dose of 0.02 mg/kg intravenously 20-30 minutes before the end of surgery. Postoperative PCA pump configuration: 0.4 mg/kg oliceridine 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. The cumulative oliceridine dose should not exceed 27 mg per 24 hours, in accordance with the FDA prescribing information. Receives: Drug: Oliceridine |
| 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. Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chronic postsurgical pain with functional impact at 3 months after surgery
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.
Measured: At 3 months after surgery (assessment window: postoperative day 90 +/- 14 days)
Secondary outcomes (11)
Postoperative acute pain NRS score
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).
Measured: 24h and 48h after surgery
Quality of Recovery-15 (QoR-15) score
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.
Measured: 24h and 48h after surgery
Cumulative PCA opioid consumption and bolus deliveries
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.
Measured: 0-48 hours postoperatively
Incidence of opioid-related adverse events
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.
Measured: 0-48 h postoperatively
Use and frequency of rescue analgesic administration
Dose and frequency of rescue analgesics
Measured: 0-48h postoperatively, 1 month postoperatively, 3 months postoperatively
Brief Pain Inventory-Short Form (BPI-SF) pain severity and pain interference scores
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.
Measured: 1 month postoperatively, 3 months postoperatively
Incidence of neuropathic pain component (DN4i ≥ 4)
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.
Measured: 1 month postoperatively, 3 months postoperatively
Sleep quality assessment
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).
Measured: 1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively
Psychological status assessment
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).
Measured: 1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively
Pain catastrophizing level
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).
Measured: 1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively
Quality of life assessment
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).
Measured: 1 day preoperatively(baseline), 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start6 Jan 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Postsurgical PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Yang Jiao, Tianjin Medical University General Hospital
- Investigators
- Yang Jiao, Doctor, Principal investigator, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018375
- Sponsor's protocol ID
- IRB2025-YX-199-01
- Status last verified
- Aug 2026
- First submitted
- 27 May 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be made available upon reasonable request to the corresponding author, following publication of the primary results, for researchers who provide a methodologically sound proposal.