Clinical trial NCT05063396: OFA in Thoracic Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thoracic Cancer
Keywords: opioid free anesthesia
non small cell lung caner
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: acute postoperative pain scores
timeFrame: day1 postoperation
measure: acute postoperative pain scores
timeFrame: day2 postoperation
measure: occurrence of postoperative opioid-related adverse events
timeFrame: day1 postoperation
measure: occurrence of postoperative opioid-related adverse events
timeFrame: day2 postoperation
Secondary outcomes:
measure: relapse free survival and overall survival
timeFrame: within 5 years
measure: occurrence of episodes of postoperative pain (VAS ≥4)
timeFrame: within 48hours
measure: PCEA bolus consumption
timeFrame: within 48hours
measure: need for rescue intravenous opioids or any type of painkiller
timeFrame: within 48hours
measure: hospital length of stay and total hospital expenses
timeFrame: within 10days
measure: Pathologic results and TNM rating
timeFrame: within one month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
city: Shanghai
country: China
facility: Zhongshan Hospital
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Changhong Miao
role: STUDY_CHAIR
References:
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.
citation: 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.