OFA in Thoracic Surgery

Thoracic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05063396
• Other study ID #: OFAbywang
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Thoracic Cancer

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