NCT02840227

Brief Summary

The primary hypothesis is that disease-free survival is improved in patients undergoing resection for tumor thought to be stage I-III primary non-small cell lung cancer in patients with combined general-epidural anesthesia \& analgesia as compared to patients receiving general anesthesia and postoperative patient-controlled opioid analgesia. Patients having surgery for resection of potentially curable lung cancer will be randomized to combined general and epidural anesthesia or general anesthesia with opioid analgesia. The primary outcome will be disease-free survival.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

December 1, 2013

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

10.5 years

First QC Date

June 20, 2016

Last Update Submit

June 18, 2024

Conditions

Non-small Cell Lung Cancer

Keywords

CancerGeneral anesthesiaEpidural anesthesia

Outcome Measures

Primary Outcomes (1)

  • Cancer-free survival

    Patients who remain alive without known lung cancer recurrence

    3 years or as available

Secondary Outcomes (5)

  • Pain intensity

    2 days

  • SF-12 Health Survey

    6, 12, 24, and 36 months

  • McGill Pain Questionnaire

    6, 12, 24, and 36 months

  • Neuropathic Pain Questionnaire

    6, 12, 24, and 36 months

  • Opioid use

    2 days

Study Arms (2)

Combined general/epidural anesthesia

EXPERIMENTAL

Combined general/epidural anesthesia and analgesia. General anesthesia may include propofol, isoflurane, sevoflurane, and other drugs. Epidural anesthesia will include bupivacaine and other local anesthetics.

Procedure: Combined general/epidural anesthesia

General anesthesia with opioid analgesia

EXPERIMENTAL

General anesthesia with routine drugs and intravenous PCA opioid analgesia. General anesthesia may include propofol, isoflurane, sevoflurane, and other drugs.

Procedure: General anesthesia with opioid analgesia

Interventions

General anesthesia with opioid analgesiaPROCEDURE

General anesthesia with routine drugs and intravenous patient controlled opioid analgesia. General anesthesia may include propofol, isoflurane, sevoflurane, and other drugs.

General anesthesia with opioid analgesia
Combined general/epidural anesthesiaPROCEDURE

Combined general/epidural anesthesia and analgesia. General anesthesia may include propofol, isoflurane, sevoflurane, and other drugs. Epidural anesthesia will include bupivacaine and other local anesthetics.

Combined general/epidural anesthesia

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tumor thought to be primary non-small cell lung cancer (stage 1-3) as determined according to the IASLC Lung Cancer Staging Project\[ref\];
  • Scheduled for potentially curative tumor resection;
  • Written informed consent, including willingness to be randomized to epidural anesthesia/analgesia plus general anesthesia or to general anesthesia and postoperative opioid analgesia;
  • ASA physical status 1-3.

You may not qualify if:

  • Any contraindication to epidural anesthesia, (including coagulopathy, abnormal anatomy).
  • Any contraindication to midazolam, propofol, sevoflurane, fentanyl, morphine, or hydromorphone.
  • Age \<18 or \>85 years old.
  • Other cancer not believed by the attending surgeon to be in long-term remission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungNeoplasms

Interventions

Anesthesia, GeneralAnesthesia, Epidural

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaAnesthesia, Conduction

Study Officials

  • Daniel I Sessler, MD

    The Cleveland Clinic

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

July 21, 2016

Study Start

December 1, 2013

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

June 20, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)