Clinical trial NCT07018375: The Effect of Oliceridine Patient-Controlled Intravenous Analgesia on Postoperative Chronic Pain After Video-Assisted Thoracoscopic Lobectomy
Official title: The Effect of Oliceridine Patient-Controlled Intravenous Analgesia on Postoperative Chronic Pain After Video-Assisted Thoracoscopic Lobectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Chronic Postsurgical Pain
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of chronic pain after surgery
timeFrame: from day 1 to day 90 after surgery
Secondary outcomes:
measure: postoperative acute pain NRS scoring
timeFrame: 24h and 48h after surgery
measure: Incidence of adverse events
timeFrame: 48 hours after surgery
measure: Chronic pain NRS score 3 months after surgery
timeFrame: 3 months postoperatively
measure: Neuropathic pain (DN4 score ≥ 4)
timeFrame: 1 day preoperatively；3 months postoperatively
measure: Sleep quality assessment
timeFrame: 1 day preoperatively；3 months postoperatively
measure: Psychological status assessment
timeFrame: 1 day preoperatively； 3 months postoperatively
measure: Evaluate pain catastrophizing levels in surgical patients
timeFrame: 1 day preoperatively；3 months postoperatively
measure: Quality of Life Assessments
timeFrame: 1 day preoperatively；3 months postoperatively
measure: Use and frequency of rescue analgesic administration
timeFrame: 1 day preoperatively；3 months postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Tianjin Medical University General Hospital
name: Yang Jiao, Doctor
role: PRINCIPAL_INVESTIGATOR
References: