NCT05063396

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

May 10, 2021

Last Update Submit

April 26, 2022

Conditions

Thoracic Cancer

Keywords

opioid free anesthesianon small cell lung caner

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • relapse free survival and overall survival

    within 5 years

  • occurrence of episodes of postoperative pain (VAS ≥4)

    within 48hours

  • PCEA bolus consumption

    within 48hours

  • need for rescue intravenous opioids or any type of painkiller

    within 48hours

  • hospital length of stay and total hospital expenses

    within 10days

  • +1 more secondary outcomes

Study Arms (2)

opioid free anesthesia

ACTIVE COMPARATOR

opioid free anesthesia

Procedure: opioid free anesthesia

Opioid-sparing anesthesia

PLACEBO COMPARATOR

Opioid-sparing anesthesia

Procedure: Opioid-sparing anesthesia

Interventions

opioid free anesthesiaPROCEDURE

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 free anesthesia
Opioid-sparing anesthesiaPROCEDURE

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

Opioid-sparing anesthesia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • psychological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

180 Fenglin Road

Shanghai, 200032, China

RECRUITING

Zhongshan Hospital

Shanghai, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 32682739BACKGROUND

  • 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.

    PMID: 30731138BACKGROUND

  • Wang S, Li Y, Liang C, Han X, Wang J, Miao C. Opioid-free anesthesia reduces the severity of acute postoperative motion-induced pain and patient-controlled epidural analgesia-related adverse events in lung surgery: randomized clinical trial. Front Med (Lausanne). 2023 Nov 6;10:1243311. doi: 10.3389/fmed.2023.1243311. eCollection 2023.

    PMID: 38020116DERIVED

Study Officials

  • Changhong Miao

    Shanghai Zhongshan Hospital

    STUDY CHAIR

Central Study Contacts

SHUWEI WANG

CONTACT

+8613564440601veronicawang228@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2021

First Posted

October 1, 2021

Study Start

October 1, 2021

Primary Completion

July 1, 2022

Study Completion

December 1, 2025

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)