Opioid-free Anesthesia in VATS Lung Resection

The Effect of Opioid-free Anesthesia on Postoperative Analgesia-related Adverse Reactions in Lung Resection With Video-assisted Thoracoscopic Access: a Randomized Double-blind Controlled Study

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).

Study Overview

• Status: Unknown
• Conditions: Opioid Free Anesthesia
• Intervention / Treatment: Procedure: Paravertebral block+Anterior serratus plane block; Drug: opioid free anesthesia; Drug: opioid based anesthesia

Detailed Description

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].

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking university People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Undergoing VATS lung resection.
• American Society of Anesthesiologists (ASA) physical status I-II.
• Agreed to participate in the trial.

Exclusion Criteria:

• Pregnant women
• ASA phase III or above.
• Undergoing emergency surgery.
• Planning for thoracotomy.
• Adults protected by law (under judicial protection, guardianship or supervision), people who deprived of their liberty.
• Patients who have received general anesthesia.
• Atrioventricular block, sinus node block or intraventricular block.
• Sinus bradycardia (heart rate is less than 60 beats/min).
• Preoperative hypotension (systolic blood pressure is less than 90mmHg)
• Combined with urolithiasis, Meniere syndrome, and vertebral artery stenosis
• Combined with cerebrovascular disease.
• Contraindication to NSAIDs drug.
• Allergic to anesthetics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: opioid-free general anesthesia; under opioid-free general anesthesia	Procedure: Paravertebral block+Anterior serratus plane block; 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.; Other Names: nerve block; Drug: opioid free anesthesia; 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).; Other Names: OFA
Active Comparator: opioid based general anesthesia; under opioid based general anesthesia	Procedure: Paravertebral block+Anterior serratus plane block; 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.; Other Names: nerve block; Drug: opioid based anesthesia; 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.; Other Names: Standard anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative duration of stay in hospital	The duration when patients stay in hospital after surgery.	30 days postoperation
Incidence of intraoperative cardiovascular complications	Including the incidence of arrhythmia, the probability of using hyperensor and hypotensor.	During the operation
Incidence of postoperative cardiovascular complications	Including the incidence of arrhythmia, the probability of using hypertensor and hypotensor.	Up to 30 days postoperation
Duration of tracheal intubation removing	From anesthetic discontinuance to tracheal extubation	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.	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.	2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation
Dosage of opioids	Total dosage of opioids postoperation	2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation
Flatus time	From the operation finished to first-time exhaust	Up to 48 hours postoperation
Defecation time	From the operation finished to first-time defecation	Up to 48 hours postoperation

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Feng Yi, MD,PhD, Peking university People's Hospital

Publications and helpful links

General Publications

• Dinges HC, Otto S, Stay DK, Baumlein S, Waldmann S, Kranke P, Wulf HF, Eberhart LH. Side Effect Rates of Opioids in Equianalgesic Doses via Intravenous Patient-Controlled Analgesia: A Systematic Review and Network Meta-analysis. Anesth Analg. 2019 Oct;129(4):1153-1162. doi: 10.1213/ANE.0000000000003887.
• Cozowicz C, Poeran J, Zubizarreta N, Liu J, Weinstein SM, Pichler L, Mazumdar M, Memtsoudis SG. Non-opioid analgesic modes of pain management are associated with reduced postoperative complications and resource utilisation: a retrospective study of obstructive sleep apnoea patients undergoing elective joint arthroplasty. Br J Anaesth. 2019 Jan;122(1):131-140. doi: 10.1016/j.bja.2018.08.027. Epub 2018 Oct 27.
• Forget P. Opioid-free anaesthesia. Why and how? A contextual analysis. Anaesth Crit Care Pain Med. 2019 Apr;38(2):169-172. doi: 10.1016/j.accpm.2018.05.002. Epub 2018 Sep 13.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 6, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Opioid Free Anesthesia; Video-assisted Thoracoscopic Surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Anesthetics; Analgesics, Opioid
• Other Study ID Numbers: 2020PHB031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No