Clinical trial NCT06570538: Analgesic Efficacy of an Opioid-free Postoperative Pain Management Strategy Versus a Conventional Opioid-based Strategy Following Video-assisted Thoracoscopic Lobectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Postoperative Pain
Keywords: Lung Cancer
Postoperative pain
OFA
Erector spinae plane block
Lead sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Postoperative 48-h analgesic efficacy at cough
timeFrame: Leave the PACU (T0), postoperative 6 hours (T1)、postoperative 12 hours (T2)、 postoperative 24 hours (T3)、 postoperative 36 hours (T4) and postoperative 48 hours (T5).
Secondary outcomes:
measure: Postoperative 48-h analgesic efficacy at rest
timeFrame: Leave the PACU, postoperative 6 hours、postoperative 12 hours、 postoperative 24 hours、 postoperative 36 hours and postoperative 48 hours .
measure: Postoperative quality of recovery
timeFrame: Postoperative 24 hours 、postoperative 48 hours
measure: Postoperative pulmonary complications
timeFrame: From the time of leaving the PACU until the time of the first occurrence of pulmonary complications or the time of death from any cause, whichever came first, assessed up to 30 days.
measure: The 48-hour postoperative rescue analgesia rate
timeFrame: First 48 hours postoperatively
measure: Postoperative analgesic failure
timeFrame: First 48 hours postoperatively
measure: Patient satisfaction with postoperative pain ratings
timeFrame: First 48 hours postoperatively
measure: Time to resume
timeFrame: From the time of leaving the PACU until the time to off-bed, bowel movement, and oral intake or the time of death from any cause, whichever came first, assessed up to 7 days.
measure: The incidence of unplanned ICU admission and reoperation
timeFrame: From the time of leaving the PACU until the time to unplanned ICU admission or reoperation or the time of death from any cause, whichever came first, assessed up to 30 days.
measure: The 30d- and 90d- mortality
timeFrame: Of the time from leaving the PACU to the time of postoperative 90day.
measure: Related Adverse Events
timeFrame: First 48 hours postoperatively
Other outcomes:
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