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to investigate the efficacy and safety of opioid-free anesthesia for non-small-cell lung cancer resection and its underlying clinical value
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| opioid free anesthesia | Active Comparator | opioid free anesthesia |
|
| Opioid-sparing anesthesia | Placebo Comparator | Opioid-sparing anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| opioid free anesthesia | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| acute postoperative pain scores | visual analog scale was used | day1 postoperation |
| acute postoperative pain scores | visual analog scale was used | day2 postoperation |
| occurrence of postoperative opioid-related adverse events | occurrence of postoperative opioid-related adverse events | day1 postoperation |
| occurrence of postoperative opioid-related adverse events | occurrence of postoperative opioid-related adverse events | day2 postoperation |
| Measure | Description | Time Frame |
|---|---|---|
| relapse free survival and overall survival | relapse free survival and overall survival | within 5 years |
| occurrence of episodes of postoperative pain (VAS ≥4) | occurrence of episodes of postoperative pain (VAS ≥4) |
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Inclusion Criteria:
Exclusion Criteria:
-psychological disorders
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SHUWEI WANG | Contact | +8613564440601 | veronicawang228@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Changhong Miao | Shanghai Zhongshan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 180 Fenglin Road | Recruiting | Shanghai | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32682739 | Background | 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. | |
| 30731138 | Background | Bello 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. |
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|
| Opioid-sparing anesthesia | Procedure | patients will receive opioid-sparing anesthesia protocol with minimal intraoperative sufentanil, remifentanil and epidural hydromorphone. |
|
| within 48hours |
| PCEA bolus consumption | PCEA bolus consumption | within 48hours |
| need for rescue intravenous opioids or any type of painkiller | need for rescue intravenous opioids or any type of painkiller | within 48hours |
| hospital length of stay and total hospital expenses | hospital length of stay and total hospital expenses | within 10days |
| Pathologic results and TNM rating | Pathologic results and TNM rating | within one month |
| Zhongshan Hospital | Recruiting | Shanghai | China |
|
| 38020116 | Derived | Wang 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. |