A Phase 4 interventional study of Oliceridine and Sufentanil in Chronic Postsurgical Pain, sponsored by Tianjin Medical University General Hospital. Recruiting at 7 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Tianjin Medical University General Hospital · Phase 4, Interventional, and Treatment
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.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 320 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Tianjin Medical University General Hospital is the lead sponsor of 75 studies on the registry; 31 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Oliceridine
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.
Drug: Sufentanil
postoperative patient-controlled analgesia (PCA)
Sufentanil
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.
Time frame: At 3 months after surgery (assessment window: postoperative day 90 +/- 14 days)
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0-48 h postoperatively
Use and frequency of rescue analgesic administration
Dose and frequency of rescue analgesics
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 1 day preoperatively(baseline), 3 months postoperatively
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be available beginning 12 months and ending 36 months after publication of the primary results.
Access criteria: Deidentified individual participant data will be shared with researchers who provide a methodologically sound proposal (including study purpose and analysis plan) approved by the study steering committee. Requests should be directed to the corresponding author (jiaoxiuxiu1987@163.com).
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Studies of the drug tested here: Oliceridine
Tianjin Medical University General Hospital