An interventional study of Paravertebral block+Anterior serratus plane block and opioid free anesthesia in Opioid Free Anesthesia, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-08-11.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
A comparison of incidences of postoperative opioid-related adverse effects and recovery parameters in patients undergoing video-assisted thoracoscopic surgery (VATS) lung resection receiving opioid or opioid-free general anesthesia (OFA).
Video-assisted thoracoscopic surgery (VATS) lung resection is traditionally performed under general anesthesia with opioid-based analgesia. It is associated with higher incidences of respiratory depression, hypotension, postoperative nausea and vomiting (PONV), dizziness, constipation and urinary retention, and more severe acute postoperative pain.
The purpose of our study is to compare the opioid-free general anesthesia with the opioid-based general anesthesia with respect to the primary outcome measures of the total incidence of opioid-related adverse effects (including respiratory depression, hypotension, PONV and dizziness) and secondary outcome measures of incidence of intraoperative and postoperative cardiovascular complications, pain relief, analgesic requirement , and other postoperative recovery parameters [e.g. duration of tracheal extubation, departing from post-anaesthesia care unit (PACU), exhaust, defecation, and stay in hospital postoperatively].
Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
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Exclusion Criteria:
under opioid-free general anesthesia
Procedure: Paravertebral block+Anterior serratus plane block · Drug: opioid free anesthesia
under opioid based general anesthesia
Procedure: Paravertebral block+Anterior serratus plane block · Drug: opioid based anesthesia
Paravertebral block will be performed at T3 and T7 level on the surgical side using out-of-plane approach under ultrasound-guided, with 0.5% ropivacaine 10ml at each injection site. Anterior serratus plane block will be performed at the 4th rib level on the surgical side under ultrasound-guided, with 0.5% ropivacaine 15ml. The blocking range is measured by "ice cube" method 15 minutes after the procedure.
Also known as: nerve block
Anesthesia induction: Dexmedetomidine 1µg/kg (intravenous infusion within 10min), propofol 1.5-2mg/kg (intravenous bolus), lidocaine 1.5-2mg/kg (intravenous bolus), cisatracurium besylate 0.15-0.3mg/kg (intravenous bolus before tracheal intubation), methylprednisolone 40mg (intravenous bolus), esmolol 1mg/kg (intravenous bolus), and 0.5% tetracaine 5ml for surface anesthesia of the throat. Maintenance of anesthesia: Continuous infusion of propofol and dexmedetomidine \[0.4μg/(kg.h)\]. The infusion rate of propofol was adjusted according to bispectral index value. Cisatracurium besylate was given as needed. Flurbiprofen 50mg was given intravenously before the skin incision and suture respectively. Remedy: If blood pressure rises (more than 30% of the mean arterial pressure after induction), and heart rate increases (more than 30% of heart rate after induction) during skin incision, lidocaine 1.5mg/kg will be given intravenously and then be continuously infused at a rate of 1.5mg/(kg.h).
Also known as: OFA
Anesthesia induction: Propofol 1.5-2mg/kg (intravenous bolus), sufentanil 0.3μg/kg (intravenous bolus), cisatracurium besylate 0.15-0.3mg/kg (intravenous bolus before tracheal intubation), methylprednisolone 40mg (intravenous bolus), esmolol 1mg/kg (intravenous bolus). Maintenance of anesthesia: Continuous infusion of propofol and remifentanil. The infusion rate of propofol was adjusted according to BIS value. The infusion rate of remifentanil was 0.1-0.5µg/(kg.min) and adjusted according to the change of heart rate and blood pressure. Cisatracurium besylate was given as needed. Sufentanil 0.1μg/kg and flurbiprofen 50mg were given intravenously before the skin incision and suture respectively.
Also known as: Standard anesthesia
Total incidence of opioid-related adverse effects of 2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation
The total incidence refers to the sum of the incidence of opioid-related adverse effects at 2h, 4h, 6h, 24h and 48h postoperationOpioid-related adverse effects here including respiratory depression, hypotension, PONV and dizziness.
Time frame: 2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation
Incidence of intraoperative cardiovascular complications
Including the incidence of arrhythmia, the probability of using hyperensor and hypotensor.
Time frame: During the operation
Incidence of postoperative cardiovascular complications
Including the incidence of arrhythmia, the probability of using hypertensor and hypotensor.
Time frame: Up to 30 days postoperation
Duration of tracheal intubation removing
From anesthetic discontinuance to tracheal extubation
Time frame: Up to 2 hours postoperation
Duration of departing from PACU
From tracheal extubation to Aldrete score\>9. Aldrete score is the standard for departing from PACU which includes five contents to evaluate: activity, breath, blood pressure, state of consciousness and oxygen saturation by pulse oximetry (SpO2). 2 point in total for each content. 2 point refers to the best state, whereas 0 point refers to the worst state. When a patient's total score greater than 9 who will be transferred out of PACU.
Time frame: Up to 4 hours postoperation
Pain severity
Using 0-10 numerical rating scale (NRS). The NRS score is ranged from 0 to 10. 0 means without pain. 1-3 means mild pain. 4-6 means moderate pain. 7-9 means severe pain. 10 means intense pain and can't bear.
Time frame: 2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation
Dosage of opioids
Total dosage of opioids postoperation
Time frame: 2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation
Flatus time
From the operation finished to first-time exhaust
Time frame: Up to 48 hours postoperation
Defecation time
From the operation finished to first-time defecation
Time frame: Up to 48 hours postoperation
Postoperative duration of stay in hospital
The duration when patients stay in hospital after surgery.
Time frame: 30 days postoperation
Plan to share: No
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Peking University People's Hospital