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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05063396
Other study ID # OFAbywang
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date December 1, 2025

Study information

Verified date April 2022
Source Shanghai Zhongshan Hospital
Contact SHUWEI WANG
Phone +8613564440601
Email veronicawang228@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

to investigate the efficacy and safety of opioid-free anesthesia for non-small-cell lung cancer resection and its underlying clinical value


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 1, 2025
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: -psychological disorders

Study Design


Related Conditions & MeSH terms


Intervention

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.
Opioid-sparing anesthesia
patients will receive opioid-sparing anesthesia protocol with minimal intraoperative sufentanil, remifentanil and epidural hydromorphone.

Locations

Country Name City State
China 180 Fenglin Road Shanghai
China Zhongshan Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary acute postoperative pain scores visual analog scale was used day1 postoperation
Primary acute postoperative pain scores visual analog scale was used day2 postoperation
Primary occurrence of postoperative opioid-related adverse events occurrence of postoperative opioid-related adverse events day1 postoperation
Primary occurrence of postoperative opioid-related adverse events occurrence of postoperative opioid-related adverse events day2 postoperation
Secondary relapse free survival and overall survival relapse free survival and overall survival within 5 years
Secondary occurrence of episodes of postoperative pain (VAS =4) occurrence of episodes of postoperative pain (VAS =4) within 48hours
Secondary PCEA bolus consumption PCEA bolus consumption within 48hours
Secondary need for rescue intravenous opioids or any type of painkiller need for rescue intravenous opioids or any type of painkiller within 48hours
Secondary hospital length of stay and total hospital expenses hospital length of stay and total hospital expenses within 10days
Secondary Pathologic results and TNM rating Pathologic results and TNM rating within one month
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