OFA in Thoracic Surgery

The Efficacy and Safety of Opioid-free Anesthesia(OFA) for Non-small-cell Lung Cancer Resection and Its Underlying Clinical Value: a Prospective Study

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

Study Overview

• Status: Recruiting
• Conditions: Thoracic Cancer
• Intervention / Treatment: Procedure: opioid free anesthesia; Procedure: Opioid-sparing anesthesia

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SHUWEI WANG; Phone Number: +8613564440601; Email: veronicawang228@126.com

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • 180 Fenglin Road
    • Contact: Guowei Tu; Phone Number: +8602164041990
  • Shanghai, China
    • Recruiting
    • Zhongshan Hospital
    • Contact: Guowei Tu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Procedure: Opioid-sparing anesthesia; patients will receive opioid-sparing anesthesia protocol with minimal intraoperative sufentanil, remifentanil and epidural hydromorphone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Chair: Changhong Miao, Shanghai Zhongshan Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2021
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): December 1, 2025

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (ACTUAL): October 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: opioid free anesthesia; non small cell lung caner
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Anesthetics; Analgesics, Opioid
• Other Study ID Numbers: OFAbywang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No