OFA in Thoracic Surgery

Not Applicable

Recruiting

• Conditions: Thoracic Cancer
• Interventions: Procedure: opioid free anesthesia; Procedure: Opioid-sparing anesthesia

• Registration Number: NCT05063396
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-09-21
• Study Start: 2021-10-01
• Study First Posted: 2021-10-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-27
• Primary Completion: 2022-07-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
opioid free anesthesia	opioid free anesthesia	opioid free anesthesia
Opioid-sparing anesthesia	Opioid-sparing anesthesia	Opioid-sparing anesthesia

Primary Outcome Measures

Name	Time	Method
acute postoperative pain scores	day2 postoperation	visual analog scale was used
occurrence of postoperative opioid-related adverse events	day2 postoperation	occurrence of postoperative opioid-related adverse events

Secondary Outcome Measures

Name	Time	Method
Pathologic results and TNM rating	within one month	Pathologic results and TNM rating
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
relapse free survival and overall survival	within 5 years	relapse free survival and overall survival

Trial Locations

Locations (2)

180 Fenglin Road; 🇨🇳 Shanghai, China

Zhongshan Hospital; 🇨🇳 Shanghai, China