Thoracic CancerNCT05063396
OFA in Thoracic Surgery
A study testing opioid free anesthesia and Opioid-sparing anesthesia in people with Thoracic Cancer, run by Shanghai Zhongshan Hospital at 2 sites in China.
Trial summary
to investigate the efficacy and safety of opioid-free anesthesia for non-small-cell lung cancer resection and its underlying clinical value Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracic Cancer
- What is being tested?
- opioid free anesthesia and Opioid-sparing anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2021to 1 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- going through thoracoscopic lung surgery including lobectomy, segmentectomy, single or multiple wedge resection, and two of the above procedures combined;
- able to complete the pain scoring face-to-face;
- no cognitive dysfunction or history of anesthetic drug allergy;
- ASA grade I-II
Who cannot join
- -psychological disorders
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
180 Fenglin Road
Shanghai, 200032
Guowei Tu, +8602164041990
- Recruiting
Zhongshan Hospital
Shanghai
Guowei Tu
About this study
Official title: The Efficacy and Safety of Opioid-free Anesthesia(OFA) for Non-small-cell Lung Cancer Resection and Its Underlying Clinical Value: a Prospective Study
to investigate the efficacy and safety of opioid-free anesthesia for non-small-cell lung cancer resection and its underlying clinical value
Read the detailed description
Opioids used to have its irreplaceable role in standard opioid-based anesthesia, yet with the help of hypnotics, local anesthetics, anti-inflammatory drugs, α-2 agonists and epidural techniques, opioid-free anesthesia (OFA) has been proved to be safe and feasible for non-cardiac major surgeries. Opioid-sparing anesthesia (OSA) is encouraged by the needs of enhanced recovery and recommended by the latest guidelines for anesthesia of lung surgery. According to previous studies, both opioid-sparing and opioid-free anesthesia would reduce the incidence of opioid-related adverse events and speed up the postoperative recovery to some extent, yet no studies ever are dedicated to compare these two different techniques.
- Conditions
- Thoracic Cancer
- Being tested
- opioid free anesthesia, Opioid-sparing anesthesia
- Keywords
- opioid free anesthesia, non small cell lung caner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioid free anesthesiaProcedure or surgery
Instead of use of large amount of opioids for intraoperative stress response and postoperative pain controlling, during the whole perioperative period patients received no opioid at all. intravenous local anesthetics and thoracic epidural were used.
Opioid-sparing anesthesiaProcedure or surgery
patients will receive opioid-sparing anesthesia protocol with minimal intraoperative sufentanil, remifentanil and epidural hydromorphone.
| Study group | Role | What they receive |
|---|---|---|
| opioid free anesthesia | Active comparator | opioid free anesthesia Receives: Procedure: opioid free anesthesia |
| Opioid-sparing anesthesia | Placebo comparator | Opioid-sparing anesthesia Receives: Procedure: Opioid-sparing anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute postoperative pain scores
visual analog scale was used
Measured: day1 postoperation
acute postoperative pain scores
visual analog scale was used
Measured: day2 postoperation
occurrence of postoperative opioid-related adverse events
occurrence of postoperative opioid-related adverse events
Measured: day1 postoperation
occurrence of postoperative opioid-related adverse events
occurrence of postoperative opioid-related adverse events
Measured: day2 postoperation
Secondary outcomes (6)
relapse free survival and overall survival
relapse free survival and overall survival
Measured: within 5 years
occurrence of episodes of postoperative pain (VAS ≥4)
occurrence of episodes of postoperative pain (VAS ≥4)
Measured: within 48hours
PCEA bolus consumption
PCEA bolus consumption
Measured: within 48hours
need for rescue intravenous opioids or any type of painkiller
need for rescue intravenous opioids or any type of painkiller
Measured: within 48hours
hospital length of stay and total hospital expenses
hospital length of stay and total hospital expenses
Measured: within 10days
Pathologic results and TNM rating
Pathologic results and TNM rating
Measured: within one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start1 Oct 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thoracic CancerStudies of the same condition, open and under way.
- 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, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Changhong Miao, Study chair, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063396
- Sponsor's protocol ID
- OFAbywang
- Status last verified
- Apr 2022
- First submitted
- 10 May 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Devine G, Cheng M, Martinez G, Patvardhan C, Aresu G, Peryt A, Coonar AS, Roscoe A. Opioid-Free Anesthesia for Lung Cancer Resection: A Case-Control Study. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):3036-3040. doi: 10.1053/j.jvca.2020.05.022. Epub 2020 May 27.
PubMed 32682739Bello M, Oger S, Bedon-Carte S, Vielstadte C, Leo F, Zaouter C, Ouattara A. Effect of opioid-free anaesthesia on postoperative epidural ropivacaine requirement after thoracic surgery: A retrospective unmatched case-control study. Anaesth Crit Care Pain Med. 2019 Oct;38(5):499-505. doi: 10.1016/j.accpm.2019.01.013. Epub 2019 Feb 5.
PubMed 30731138Wang S, Li Y, Liang C, Han X, Wang J, Miao C. Opioid-free anesthesia reduces the severity of acute postoperative motion-induced pain and patient-controlled epidural analgesia-related adverse events in lung surgery: randomized clinical trial. Front Med (Lausanne). 2023 Nov 6;10:1243311. doi: 10.3389/fmed.2023.1243311. eCollection 2023.
PubMed 38020116
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Opioid-free Anesthesia(OFA) for Non-small-cell Lung Cancer Resection and Its Underlying Clinical Value: a Prospective Study
- ClinicalTrials.gov ID
- NCT05063396
- Acronym / sponsor ID
- OFAbywang
- Conditions
- Thoracic Cancer
- Keywords
- opioid free anesthesia, non small cell lung caner
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 1 Oct 2021 (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.
to investigate the efficacy and safety of opioid-free anesthesia for non-small-cell lung cancer resection and its underlying clinical value
Detailed description
Opioids used to have its irreplaceable role in standard opioid-based anesthesia, yet with the help of hypnotics, local anesthetics, anti-inflammatory drugs, α-2 agonists and epidural techniques, opioid-free anesthesia (OFA) has been proved to be safe and feasible for non-cardiac major surgeries. Opioid-sparing anesthesia (OSA) is encouraged by the needs of enhanced recovery and recommended by the latest guidelines for anesthesia of lung surgery. According to previous studies, both opioid-sparing and opioid-free anesthesia would reduce the incidence of opioid-related adverse events and speed up the postoperative recovery to some extent, yet no studies ever are dedicated to compare these two different techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid free anesthesia | Active comparator | Procedure: opioid free anesthesiaopioid free anesthesia |
| Opioid-sparing anesthesia | Placebo comparator | Procedure: Opioid-sparing anesthesiaOpioid-sparing anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- going through thoracoscopic lung surgery including lobectomy, segmentectomy, single or multiple wedge resection, and two of the above procedures combined;
- able to complete the pain scoring face-to-face;
- no cognitive dysfunction or history of anesthetic drug allergy;
- ASA grade I-II
Key exclusion criteria (1 listed)
- -psychological disorders
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 |
|---|---|---|
| opioid free anesthesiaInstead of use of large amount of opioids for intraoperative stress response and postoperative pain controlling, during the whole perioperative period patients received no opioid at all. intravenous local anesthetics and thoracic epidural were used. | Procedure or surgery | opioid free anesthesia |
| Opioid-sparing anesthesiapatients will receive opioid-sparing anesthesia protocol with minimal intraoperative sufentanil, remifentanil and epidural hydromorphone. | Procedure or surgery | Opioid-sparing anesthesia |
Primary outcome
acute postoperative pain scores
Time frame: day1 postoperation
visual analog scale was used
acute postoperative pain scores
Time frame: day2 postoperation
visual analog scale was used
occurrence of postoperative opioid-related adverse events
Time frame: day1 postoperation
occurrence of postoperative opioid-related adverse events
occurrence of postoperative opioid-related adverse events
Time frame: day2 postoperation
occurrence of postoperative opioid-related adverse events
6 secondary outcomes
relapse free survival and overall survival
Time frame: within 5 years
occurrence of episodes of postoperative pain (VAS ≥4)
Time frame: within 48hours
PCEA bolus consumption
Time frame: within 48hours
need for rescue intravenous opioids or any type of painkiller
Time frame: within 48hours
hospital length of stay and total hospital expenses
Time frame: within 10days
Pathologic results and TNM rating
Time frame: within one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Background: PubMed 32682739Devine G, Cheng M, Martinez G, Patvardhan C, Aresu G, Peryt A, Coonar AS, Roscoe A. Opioid-Free Anesthesia for Lung Cancer Resection: A Case-Control Study. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):3036-3040. doi: 10.1053/j.jvca.2020.05.022. Epub 2020 May 27.
- Background: PubMed 30731138Bello M, Oger S, Bedon-Carte S, Vielstadte C, Leo F, Zaouter C, Ouattara A. Effect of opioid-free anaesthesia on postoperative epidural ropivacaine requirement after thoracic surgery: A retrospective unmatched case-control study. Anaesth Crit Care Pain Med. 2019 Oct;38(5):499-505. doi: 10.1016/j.accpm.2019.01.013. Epub 2019 Feb 5.
- Derived from this study: PubMed 38020116Wang S, Li Y, Liang C, Han X, Wang J, Miao C. Opioid-free anesthesia reduces the severity of acute postoperative motion-induced pain and patient-controlled epidural analgesia-related adverse events in lung surgery: randomized clinical trial. Front Med (Lausanne). 2023 Nov 6;10:1243311. doi: 10.3389/fmed.2023.1243311. eCollection 2023.
- 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.
Changhong Miao study chair
Shanghai Zhongshan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing opioid free anesthesia and Opioid-sparing anesthesia in people with Thoracic Cancer, run by Shanghai Zhongshan Hospital at 2 sites 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 4 inclusion and 1 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 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 SHUWEI WANG (+8613564440601, veronicawang228@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute postoperative pain scores (time frame: day1 postoperation). The study lists 4 primary outcomes in all. 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 NCT05063396, which also lists 3 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 27 Apr 2022.