NCT Number: NCT06570538
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Early Phase 1
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Erector spinae plane block
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.
Other names: Intravenous analgesia
Time frame: 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).
The primary outcome is to compare the overall postoperative 48-h analgesic efficacy with cough as indicated by the cumulative area under curve (AUC) for the NRS over the 48-h period using the trapezoidal rule;
Time frame: Leave the PACU, postoperative 6 hours、postoperative 12 hours、 postoperative 24 hours、 postoperative 36 hours and postoperative 48 hours .
Compare the overall postoperative 48-h analgesic efficacy at rest as indicated by the cumulative area under curve (AUC) for the NRS over the 48-h period using the trapezoidal rule;
Time frame: Postoperative 24 hours 、postoperative 48 hours
Quality of recovery-15 (QoR-15) over the first postoperative 24 and 48 hours.
Time frame: 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.
Postoperative pulmonary complications are defined as a series of respiratory abnormalities that occur in patients after thoracoscopically assisted lobectomy. These complications may include, but are not limited to: prolonged oxygenation, pulmonary atelectasis, respiratory failure, ARDS, postoperative pneumonia, pleural effusion, pneumothorax, bronchospasm, aspiration pneumonia, and unplanned new or prolonged invasive mechanical ventilation.
Time frame: First 48 hours postoperatively
The 48-hour postoperative rescue analgesia rate was defined as the percentage of patients requiring additional analgesic medication due to inadequate pain control (NRS score ≥4 at rest) during the 48-hour postoperative period as a proportion of the total number of patients in the group.
Time frame: First 48 hours postoperatively
Postoperative analgesic failure was defined as that during postoperative period, the patient uses a pain pump for pain control, and even after implementing rescue analgesic measures, the patient's resting NRS score remains ≥4, or the NRS score during activities (such as coughing) remains ≥7. This indicates that the pain control has not achieved the expected effect and is considered analgesia failure.
Time frame: First 48 hours postoperatively
Patients' satisfaction with analgesic effect will be assessed using Likert scales, where 1 = extremely dissatisfied, 2 = somewhat dissatisfied, 3 = neutral, 4 = somewhat satisfied, and 5 = extremely satisfied
Time frame: 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.
The time to off-bed, bowel movement, and oral intake.( measured in days)
Time frame: 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.
The incidence of postoperative ICU admissions was defined as the number of patients requiring ICU transfer after surgery as a percentage of the total number of surgical patients over a given period of time.
The incidence of reoperation was defined as the number of patients requiring additional surgery due to complications or other medical necessities arising after the initial surgery as a percentage of the total number of patients operated on during a given period of time.
Time frame: Of the time from leaving the PACU to the time of postoperative 90day.
Postoperative 30-day mortality is usually defined as the percentage of patients who die from any cause within 30 days of surgery. This metric is often used to assess the risk of surgery and postoperative recovery.
Postoperative 90-day mortality, on the other hand, refers to the proportion of patients who die from any cause within 90 days of surgery. This metric is also used to assess surgical outcomes and long-term patient recovery.
Time frame: First 48 hours postoperatively
ESPB-related adverse events and opioid-related adverse events ESPB-related adverse events: local infection, local hemorrhage, hematoma, pneumothorax, neurologic injury, local anesthetic toxicity, allergy, epidural anesthesia, total spinal anesthesia, palpitations, perioperative extubation, shock, and death.
Opioid-related adverse events: postoperative respiratory depression, postoperative nausea and vomiting, postoperative delirium, postoperative constipation and intestinal obstruction, postoperative urinary retention, pruritus, drug abuse, and addiction.
Contact information is provided by the study sponsor or research team.
Junqiang Hu, bachelor
CONTACT
Yonghua Yao, master
CONTACT
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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