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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05063396
Enrollment
60
Registered
2021-10-01
Start date
2021-10-01
Completion date
2025-12-01
Last updated
2022-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Cancer

Keywords

opioid free anesthesia, non small cell lung caner

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.

Interventions

PROCEDUREopioid 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.

PROCEDUREOpioid-sparing anesthesia

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

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
acute postoperative pain scoresday1 postoperationvisual analog scale was used
occurrence of postoperative opioid-related adverse eventsday1 postoperationoccurrence of postoperative opioid-related adverse events

Secondary

MeasureTime frameDescription
PCEA bolus consumptionwithin 48hoursPCEA bolus consumption
need for rescue intravenous opioids or any type of painkillerwithin 48hoursneed for rescue intravenous opioids or any type of painkiller
relapse free survival and overall survivalwithin 5 yearsrelapse free survival and overall survival
Pathologic results and TNM ratingwithin one monthPathologic results and TNM rating
hospital length of stay and total hospital expenseswithin 10dayshospital length of stay and total hospital expenses
occurrence of episodes of postoperative pain (VAS ≥4)within 48hoursoccurrence of episodes of postoperative pain (VAS ≥4)

Countries

China

Contacts

Primary ContactSHUWEI WANG
veronicawang228@126.com+8613564440601

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026