The Effect of Oliceridine Patient-Controlled Intravenous Analgesia on Postoperative Chronic Pain After Video-Assisted Thoracoscopic Lobectomy

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oliceridine

    Drug

    postoperative patient-controlled analgesia (PCA)

  • Sufentanil

    Drug

    Sufentanil

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: Oliceridine groupExperimental treatment 1 intervention
Group B: Sufentanil GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of chronic pain after surgery

Chronic pain intensity was assessed by a numeric rating scale (NRS) using a telephone questionnaire

Time frame
from day 1 to day 90 after surgery

Secondary outcomes

1

postoperative acute pain NRS scoring

Acute pain NRS score (rest versus cough) at 24 and 48 hours after surgery

Time frame
24h and 48h after surgery
2

Incidence of adverse events

Time frame
48 hours after surgery
3

Chronic pain NRS score 3 months after surgery

assessed by NRS scale

Time frame
3 months postoperatively
4

Neuropathic pain (DN4 score ≥ 4)

the DN4 questionnaire is a brief and user-friendly screening tool designed to identify the presence of neuropathic pain components

Time frame
1 day preoperatively;3 months postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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