Clinical trial · Interventional
Analgesic Efficacy of an Opioid-free Postoperative Pain Management Strategy Versus a Conventional Opioid-based Strategy Following Video-assisted Thoracoscopic Lobectomy
Analgesic Efficacy of an Opioid-free Postoperative Pain Management Strategy Versus a Conventional Opioid-based Strategy Following Video-assisted Thoracoscopic Lobectomy: an Open-label, Randomized, Controlled, Non-inferiority Trial
NCT06570538CI-TRIAL-00080164unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Investigators have designed a randomized controlled trial. Utilizing an open-label, randomized, controlled study methodology, this trial aims to explore a opioid-free, safe, and effective analgesic approach for thoracic surgery. It also seeks to provide clinical guidance for the implementation of opioid-free or reduced-opioid postoperative analgesia in other thoracic procedures, aiming to optimize postoperative pain management for patients and ultimately enhance the overall patients recovery experience.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ropivacaine | Drug | — | UNRESOLVED |
| Sufentanil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ESPB Group
- description
- The drug composition of the analgesic pump for erector spinae block was 300 mL of 0.25% ropivacaine, the mode was intermittent pumping, and the parameters were set as follows: 30 mL of the first dose, 5 mL/h of the background dose, and 10 mL of the pumping every 6h for the first 24 hours after the operation.
- interventionNames
- Drug: Ropivacaine
- type
- ACTIVE_COMPARATOR
- label
- Convention group
- description
- Intravenous analgesic is sufentanil ( 2.0 μg/kg), 0.9% saline diluted to 100 mL, background dose of 2 ml/h, no loading dose, activated after extubation and continued until 48 hours postoperatively.
- interventionNames
- Drug: Sufentanil
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion criteria: * Aged between 18 and 65 years. * Patients with lung cancer or suspected lung cancer who are undergoing lobectomy surgery via Video-assisted thoracoscopic surgery (VATS) or Robotic-assisted thoracoscopic surgery (RATS). * American anesthesiologist association (ASA) physical status classificationⅠ-Ⅲ. * Surgery is expected to last at least 2 hours, with a minimum of 2 days of postoperative hospitalization. * Patients participate voluntarily and have signed an informed consent form. Exclusion Criteria: * Patients who underwent open-heart surgery. * Patients with BMI ≥30 kg/m², or ≤18.5 kg/m². * Patients who are allergic to any of the local anesthetic drugs, such as ropivacaine, lidocaine, bupivacaine, procaine, bupivacaine, benzocaine, dacronin, etc. * Patients who are allergic to any of the general anesthesia drugs, such as those including propofol, sufentanil, remifentanil, etc. * Patients who currently have active ulcers or have gastrointestinal bleeding or who are allergic to any NSAIDs such as parecoxib sodium, flurbiprofenol ester, and acetaminophen. * Patients with contraindications to epidural spinal plane block (ESPB), such as skin infection near the puncture site or coagulation disorders. * Patients allergic to ultrasound gel. * Patients with significant preoperative renal insufficiency (creatinine more than twice the upper limit of normal). * Patients with severe spinal deformities prior to surgery. * Patients with preoperative distant tumor metastasis. * Patients who have experienced cardiovascular or cerebrovascular accidents within the past six months. * Patients with unstable angina, ischemic myocardial infarction, or heart failure in the last six months. * Patients with severe preoperative lung disease (such as pulmonary fibrosis, severe lung abscess, pulmonary heart disease; or with FEV1 less than 50% of the predicted value, PaO2 ≤ 60 mmHg, PaCO2 \> 50 mmHg). * Patients with poorly controlled preoperative hypertension or diabetes mellitus. * Patients with a past history of dementia, psychosis, or other neurological disorders. * Patients undergoing concurrent treatment for other surgical conditions. * Patients taking sedatives, antidepressants, or hormonal medications. * Patients with chronic pain, alcoholism, or drug dependence. * Patients who are pregnant or breastfeeding * Patients with other potentially serious medical conditions. * Patients who are unable to understand Mandarin or Cantonese. * Patients who participated in other clinical trials in the past 3 months * Patients who refuse to participate in the study or sign the informed consent form.
References
Publications (0)
Data not yet available
No reference posted for this study.