OFA in Thoracic Surgery
Study Details
Study Description
Brief Summary
to investigate the efficacy and safety of opioid-free anesthesia for non-small-cell lung cancer resection and its underlying clinical value
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: opioid free anesthesia opioid free anesthesia |
Procedure: opioid free anesthesia
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.
|
| Placebo Comparator: Opioid-sparing anesthesia Opioid-sparing anesthesia |
Procedure: Opioid-sparing anesthesia
patients will receive opioid-sparing anesthesia protocol with minimal intraoperative sufentanil, remifentanil and epidural hydromorphone.
|
Outcome Measures
Primary Outcome Measures
- acute postoperative pain scores [day1 postoperation]
visual analog scale was used
- acute postoperative pain scores [day2 postoperation]
visual analog scale was used
- 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]
occurrence of postoperative opioid-related adverse events
Secondary Outcome Measures
- relapse free survival and overall survival [within 5 years]
relapse free survival and overall survival
- occurrence of episodes of postoperative pain (VAS ≥4) [within 48hours]
occurrence of episodes of postoperative pain (VAS ≥4)
- PCEA bolus consumption [within 48hours]
PCEA bolus consumption
- need for rescue intravenous opioids or any type of painkiller [within 48hours]
need for rescue intravenous opioids or any type of painkiller
- hospital length of stay and total hospital expenses [within 10days]
hospital length of stay and total hospital expenses
- Pathologic results and TNM rating [within one month]
Pathologic results and TNM rating
Eligibility Criteria
Criteria
Inclusion Criteria:
-
going through thoracoscopic lung surgery including lobectomy, segmentectomy, single or multiple wedge resection, and two of the above procedures combined;
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able to complete the pain scoring face-to-face;
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no cognitive dysfunction or history of anesthetic drug allergy;
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ASA grade I-II
Exclusion Criteria:
-psychological disorders
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 180 Fenglin Road | Shanghai | China | 200032 | |
| 2 | Zhongshan Hospital | Shanghai | China |
Sponsors and Collaborators
- Shanghai Zhongshan Hospital
Investigators
- Study Chair: Changhong Miao, Shanghai Zhongshan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- OFAbywang