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
Overview
- Phase
- Early Phase 1
- Intervention
- Ropivacaine
- Conditions
- Postoperative Pain
- Sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Enrollment
- 140
- Primary Endpoint
- Postoperative 48-h analgesic efficacy at cough
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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.
Arms & Interventions
ESPB Group
The drug composition of the analgesic pump for erector spinae block was 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.
Intervention: Ropivacaine
Convention group
Intravenous analgesic is 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.
Intervention: Sufentanil
Outcomes
Primary Outcomes
Postoperative 48-h analgesic efficacy at cough
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;
Secondary Outcomes
- Postoperative pulmonary complications(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 analgesic failure(First 48 hours postoperatively)
- Patient satisfaction with postoperative pain ratings(First 48 hours postoperatively)
- Time to resume(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 incidence of unplanned ICU admission and reoperation(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 30d- and 90d- mortality(Of the time from leaving the PACU to the time of postoperative 90day.)
- Postoperative 48-h analgesic efficacy at rest(Leave the PACU, postoperative 6 hours、postoperative 12 hours、 postoperative 24 hours、 postoperative 36 hours and postoperative 48 hours .)
- Postoperative quality of recovery(Postoperative 24 hours 、postoperative 48 hours)
- The 48-hour postoperative rescue analgesia rate(First 48 hours postoperatively)
- Related Adverse Events(First 48 hours postoperatively)