Analgesic Efficacy of an Opioid-free Postoperative Pain Management Strategy Versus a Conventional Opioid-based Strategy Following Video-assisted Thoracoscopic Lobectomy

Trial Title: Analgesic Efficacy of an Opioid-free Postoperative Pain Management Strategy Versus a Conventional Opioid-based Strategy Following Video-assisted Thoracoscopic Lobectomy

NCT ID: NCT06570538

Condition: Postoperative Pain

Conditions: Official terms:
Pain, Postoperative
Sufentanil
Ropivacaine

Conditions: Keywords:
Lung Cancer
Postoperative pain
OFA
Erector spinae plane block

Study type: Interventional

Study phase: Early Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Masking description: In view of ethical considerations, the study was not blinded to anesthesiologists and patients, and the investigator responsible for postoperative follow-up was not involved in intraoperative anesthesia management.

Intervention:

Intervention type: Drug
Intervention name: Ropivacaine
Description: 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.
Arm group label: ESPB Group

Other name: Erector spinae plane block

Intervention type: Drug
Intervention name: Sufentanil
Description: 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.
Arm group label: Convention group

Other name: Intravenous analgesia

Summary: 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.

Detailed description: Patients who undergo thoracoscopic lobectomy are often at an elevated risk of opioid-related complications due to their reliance on opioids. This overdependence not only decelerates the postoperative recovery process but also significantly increases healthcare costs. Although there is a surge of interest in opioid-free anesthetic analgesia (OFA) for its potential to reduce adverse outcomes associated with opioid use, there is a dearth of randomized controlled trials examining the efficacy of postoperative analgesia in patients undergoing thoracoscopic surgery. Consequently, the actual effectiveness of OFA in improving postoperative pulmonary complications and facilitating patient recovery remains unclear. Its application is still in the exploratory phase, with clinical practice lacking definitive guidelines to endorse or discard OFA as an alternative for postoperative analgesia in thoracoscopic surgery. To bridge this knowledge gap and evaluate the perioperative analgesic efficacy of OFA compared to traditionally used opioids in selected cancer patients undergoing thoracoscopic surgery, 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 patient recovery experience.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: Accepts Healthy Volunteers

Start date: September 1, 2024

Completion date: June 30, 2025

Lead sponsor:
Agency: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Agency class: Other

Source: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06570538