Status:
NOT_YET_RECRUITING
Analgesic Efficacy of an Opioid-free Postoperative Pain Management Strategy Versus a Conventional Opioid-based Strategy Following Video-assisted Thoracoscopic Lobectomy
Lead Sponsor:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Conditions:
Postoperative Pain
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief 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 ap...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06570538
Start Date
September 1 2024
End Date
June 30 2025
Last Update
August 26 2024
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