Epidural Anesthesia-analgesia and Long-term Survival After Lung Cancer Surgery

NCT02801409 | Completed DMC

• 2 other identifiers: 2013[653]ChiCTR-TRC-14004136
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Available studies suggest that regional anesthesia-analgesia may decrease the occurrence of recurrence/metastasis in patients after cancer surgery. However, evidences from prospective studies are still lacking. The purpose of this randomized controlled trial is to investigate the effect of epidural anesthesia-analgesia on recurrence-free survival in patients undergoing lung cancer surgery.

Conditions

Lung Cancer; Thoracic Surgery; Anesthesia, Epidural; Neoplasm Recurrence, Local; Neoplasm Metastasis

Keywords

Lung Cancer; Surgical Resection; Epidural Anesthesia and Analgesia; Cancer recurrence/metastasis; Long-Term Outcome

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival after surgery.

  Time from surgery to the earliest date of recurrence/metastasis or death from any cause, whichever came first.

  Up to 4 years after surgery.

Secondary Outcomes (8)

• Rate of intensive care unit admission after surgery.

  Up to 30 days after surgery.

• Incidence of postoperative complications during hospital stay.

  Up to 30 days after surgery.

• Duration of chest tube placement.

  Up to 30 days after surgery.

• Length of stay in hospital after surgery.

  Up to 30 days after surgery.

• Rate of all-cause mortality during hospital stay after surgery.

  Up to 30 days after surgery.

Other Outcomes (7)

• Pain intensity after surgery.

  During the first 3 days after surgery.

• Recurrence-free survival in cancer patients.

  Up to 4 years after surgery.

• Overall survival in cancer patients.

  Up to 4 years after surgery.

Study Arms (2)

General anesthesia alone

ACTIVE COMPARATOR

General anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery.

Drug: General anesthesia alone

Combined epidural-general anesthesia

EXPERIMENTAL

Combined epidural-general anesthesia is performed during surgery; patient-controlled epidural analgesia is provided after surgery.

Drug: Combined epidural-general anesthesia

Interventions

General anesthesia alone DRUG

General anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery.

General anesthesia alone

Combined epidural-general anesthesia DRUG

Combined epidural-general anesthesia is performed during surgery; patient-controlled epidural analgesia is provided after surgery.

Combined epidural-general anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (aged 18-80 years);
• Clinically diagnosed as primary non-small cell lung cancer of stage IA to IIIA, and scheduled for radical surgery;
• Agreed to receive patient-controlled analgesia after surgery.

You may not qualify if:

• Distant metastasis, malignant tumor in other organs, or chemo-/radiotherapy or other anti-cancer therapy before surgery;
• Comorbid with autoimmune diseases, or glucocorticoid/immunosuppressant therapy within 1 year;
• History of schizophrenia, epilepsy or Parkinson disease, or unable to complete preoperative assessment due to severe dementia, language barrier, or end-stage disease;
• Severe hepatic disease (Child-Pugh classification C), renal failure (serum creatinine \>442 umol/L or receiving renal replacement therapy), or American Society of Anesthesiologists classification IV or higher;
• History of anesthesia and/or surgery within 1 year;
• Contraindications to epidural anesthesia, including spinal deformity, coagulation dysfunction, local infection, and history of spinal trauma/surgery;
• Allergic to any medications used during the study.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

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MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Recurrence, Local; Neoplasm Metastasis; Agnosia

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2016
• First Posted: June 15, 2016
• Study Start: May 25, 2015
• Primary Completion: November 11, 2017
• Study Completion: November 30, 2019
• Last Updated: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)