Opioid Free AnesthesiaNCT04507165
Opioid-free Anesthesia in VATS Lung Resection
A study testing Paravertebral block+Anterior serratus plane block, opioid free anesthesia and opioid based anesthesia in people with Opioid Free Anesthesia, run by Peking University People's Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Opioid Free Anesthesia
- What is being tested?
- Paravertebral block+Anterior serratus plane block, opioid free anesthesia and opioid based anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Aug 2020to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing VATS lung resection.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Agreed to participate in the trial.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: 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).
Read the 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].
- Conditions
- Opioid Free Anesthesia
- Being tested
- Paravertebral block+Anterior serratus plane block, opioid free anesthesia, opioid based anesthesia
- Keywords
- Opioid Free Anesthesia, Video-assisted Thoracoscopic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral block+Anterior serratus plane blockProcedure or surgery
Also called nerve 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.
opioid free anesthesiaDrug
Also called OFA
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).
opioid based anesthesiaDrug
Also called Standard 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.
| Study group | Role | What they receive |
|---|---|---|
| opioid-free general anesthesia | Experimental | under opioid-free general anesthesia Receives: Procedure: Paravertebral block+Anterior serratus plane block; Drug: opioid free anesthesia |
| opioid based general anesthesia | Active comparator | under opioid based general anesthesia Receives: Procedure: Paravertebral block+Anterior serratus plane block; Drug: opioid based anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation
Secondary outcomes (9)
Incidence of intraoperative cardiovascular complications
Including the incidence of arrhythmia, the probability of using hyperensor and hypotensor.
Measured: During the operation
Incidence of postoperative cardiovascular complications
Including the incidence of arrhythmia, the probability of using hypertensor and hypotensor.
Measured: Up to 30 days postoperation
Duration of tracheal intubation removing
From anesthetic discontinuance to tracheal extubation
Measured: 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.
Measured: 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.
Measured: 2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation
Dosage of opioids
Total dosage of opioids postoperation
Measured: 2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation
Flatus time
From the operation finished to first-time exhaust
Measured: Up to 48 hours postoperation
Defecation time
From the operation finished to first-time defecation
Measured: Up to 48 hours postoperation
Postoperative duration of stay in hospital
The duration when patients stay in hospital after surgery.
Measured: 30 days postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study startAug 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Opioid Free AnesthesiaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
- Investigators
- Feng Yi, MD,PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507165
- Sponsor's protocol ID
- 2020PHB031
- Status last verified
- Aug 2020
- First submitted
- 31 Jul 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30418234Cozowicz 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.
PubMed 30579391Forget 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.
PubMed 29775728Zhang R, Wu Y, Wang X, Zhang W, Feng Y. Efficacy of opioid-free anesthesia in reducing postoperative adverse events for thoracoscopic pulmonary surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Dec 12;25(1):607. doi: 10.1186/s12871-025-03497-x.
PubMed 41388253
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04507165
- Acronym / sponsor ID
- 2020PHB031
- Conditions
- Opioid Free Anesthesia
- Keywords
- Opioid Free Anesthesia, Video-assisted Thoracoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid-free general anesthesia | Experimental | Procedure: Paravertebral block+Anterior serratus plane block, Drug: opioid free anesthesiaunder opioid-free general anesthesia |
| opioid based general anesthesia | Active comparator | Procedure: Paravertebral block+Anterior serratus plane block, Drug: opioid based anesthesiaunder opioid based general anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing VATS lung resection.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Agreed to participate in the trial.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paravertebral block+Anterior serratus plane blockAlso: nerve blockParavertebral 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. | Procedure or surgery | opioid based general anesthesia, opioid-free general anesthesia |
| opioid free anesthesiaAlso: OFAAnesthesia 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). | Drug | opioid-free general anesthesia |
| opioid based anesthesiaAlso: Standard anesthesiaAnesthesia 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. | Drug | opioid based general anesthesia |
Primary outcome
Total incidence of opioid-related adverse effects of 2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation
Time frame: 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.
9 secondary outcomes
Incidence of intraoperative cardiovascular complications
Time frame: During the operation
Incidence of postoperative cardiovascular complications
Time frame: Up to 30 days postoperation
Duration of tracheal intubation removing
Time frame: Up to 2 hours postoperation
Duration of departing from PACU
Time frame: Up to 4 hours postoperation
Pain severity
Time frame: 2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation
Dosage of opioids
Time frame: 2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation
Flatus time
Time frame: Up to 48 hours postoperation
Defecation time
Time frame: Up to 48 hours postoperation
Postoperative duration of stay in hospital
Time frame: 30 days postoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Background: PubMed 30418234Dinges 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.
- Background: PubMed 30579391Cozowicz 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.
- Background: PubMed 29775728Forget 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.
- Derived from this study: PubMed 41388253Zhang R, Wu Y, Wang X, Zhang W, Feng Y. Efficacy of opioid-free anesthesia in reducing postoperative adverse events for thoracoscopic pulmonary surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Dec 12;25(1):607. doi: 10.1186/s12871-025-03497-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng Yi, MD,PhD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paravertebral block+Anterior serratus plane block, opioid free anesthesia and opioid based anesthesia in people with Opioid Free Anesthesia, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Yi, MD,PhD (86-010-88325581, yifeng65@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total incidence of opioid-related adverse effects of 2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation (time frame: 2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04507165, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.