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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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087448
Enrollment
Unknown
Registered
2024-07-26
Start date
2024-07-28
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative pain

Interventions

E:The patient is receiving intermittent infusions of 0.25% ropivacaine under the plane of the erector spinae muscle, with a total volume of 300 ml. The parameters are set as follows: an initial dose o
C:The patient is receiving a continuous intravenous infusion of sufentanil at a rate of 2 micrograms per kilogram, diluted to 100 ml with 0.9% saline solution, with a background dose of 2 ml per hour

Sponsors

Guangzhou Institute of Cancer Research, the Affiliated Cancer Hospital, Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age between 18 and 65 years old; (2) Patients with lung cancer or suspected lung cancer undergoing lobectomy surgery assisted by video-assisted thoracoscopic surgery (VATS) or robotic-assisted thoracoscopic surgery (RATS); (3) ASA Class I to III; (4) Surgery time of at least 2 hours, and a minimum of 2 days of postoperative hospital stay; (5) Patients voluntarily participate and have signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients undergoing open-chest surgery; 2. BMI = 30 kg/m² or = 18.5 kg/m²; 3. Patients allergic to any local anesthetics, such as Ropivacaine, Lidocaine, Bupivacaine, Procaine, Tetracaine, Benzocaine, Dyclonine, etc.; 4. Patients allergic to any general anesthetics, such as Propofol, Sufentanil, Remifentanil, etc.; 5. Patients with active ulcers or gastrointestinal bleeding, or allergic to any non-steroidal anti-inflammatory drugs, such as Parecoxib Sodium, Flurbiprofen, Acetaminophen, etc.; 6. Patients with contraindications to ESPB , such as skin infection near the puncture site, abnormal coagulation function, etc.; 7. Patients allergic to ultrasound gel; 8. Patients with significant preoperative renal insufficiency (creatinine more than twice the upper limit of normal); 9. Patients with severe spinal deformity before surgery; 10. Patients with distant tumor metastasis before surgery; 11. Patients with cardiovascular and cerebrovascular accidents in the past 6 months; 12. Patients with unstable angina, ischemic myocardial infarction, or heart failure in the past 6 months; 13. Patients with severe pulmonary disease before surgery (pulmonary fibrosis, severe lung abscess, cor pulmonale; or FEV1 less than 50% of the predicted value, PaO2 = 60 mmHg, PaCO2 > 50 mmHg); 14. Patients with poorly controlled hypertension or diabetes before surgery; 15. Patients with a history of dementia, mental illness, or other neurological diseases; 16. Patients undergoing treatment for other surgical diseases at the same time; 17. Patients taking sedatives, antidepressants, or hormones; 18. Patients with chronic pain, alcoholism, or drug dependence; 19. Pregnant or lactating patients; 20. Patients with other potential serious diseases; 21. Patients who cannot understand Mandarin or Cantonese; 22. Patients who have participated in other clinical trials within the last 3 months; 23. Patients who refuse to participate in the study or sign the informed consent form for the study.

Design outcomes

Primary

MeasureTime frame
The overall analgesic effect within 48 hours postoperatively for both groups of patients: that is, the cumulative pain scores during coughing and the area under the curve weighted by time(AUCPACU-48h).;

Secondary

MeasureTime frame
Postoperative Recovery Quality: the time of the first time getting out of bed, the time of the first meal, the time of the first bowel movement, the duration of chest tube placement, and the length of the hospital stay after surgery; the Quality of Recovery-15 (QoR-15) scores at 24 hours and 48 hours postoperatively; the incidence of postoperative ICU admission and the rate of reoperation.;Anesthesia-related events: NRS (Numerical Rating Scale) scores at rest and during coughing in the postoperative period; the rate of rescue analgesia and the dosage of rescue analgesic drugs within 48 hours postoperatively; the consumption of opioid drugs at 24 hours and 48 hours postoperatively; the rate of analgesic failure; patient satisfaction with the analgesic effect at 24 hours and 48 hours postoperatively ( Likert scale); the incidence of chronic postoperative pain.;Postoperative pulmonary complications;

Countries

China

Contacts

Public ContactYao Yonghua

Guangzhou Institute of Cancer Research, the Affiliated Cancer Hospital, Guangzhou Medical University

yaoyonghua01@126.com+86 137 1156 8864

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026