The Effect of Analgesic Modalities on Long Term Outcomes Following Open Liver Resection

NCT03813953 | Completed

• 1 other identifier: 258352
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The LIVER (Local Infiltration Versus Epidural after Liver Resection) and LIVER 2 (Local Infiltration Versus Epidural after Liver Resection 2) studies were randomised controlled trials that compared epidural analgesia with local anaesthetic wound infiltration as post-operative analgesia in patients undergoing open liver resection. The overall findings of this trial were of similar rates of morbidity and pain control post-operatively but a reduced recovery time for the wound catheter group. As a result, wound catheter local anesthetic infiltration has become increasingly utilized in this unit and within other units throughout the country and worldwide. Epidural use has been associated with improved long term outcomes following abdominal cancer surgery. This study is therefore a long term follow up study of the LIVER and LIVER 2 trials to assess survival between the two groups.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival in months

  Number of months from the date of surgery to the date of death or the censor date

  5 years

Secondary Outcomes (2)

• overall survival

  3 years

• Disease free survival

  5 years

Study Arms (2)

Local Anaesthetic Wound Infiltration

EXPERIMENTAL

Wound catheter delivering local anaesthetic for 48 hours post-operatively following liver resection

Procedure: Liver resection

Epidural

ACTIVE COMPARATOR

Conventional practice following liver resection

Procedure: Liver resection

Interventions

Liver resection PROCEDURE

Resection of diseased liver

Epidural; Local Anaesthetic Wound Infiltration

Eligibility Criteria

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

You may qualify if:

• Patients who participated in the LIVER and LIVER 2 trials who had diagnoses of a malignancy and underwent liver resection for this malignancy.

You may not qualify if:

• Patients who had liver resection for benign disease. Patients who participated in the LIVER/LIVER2 trials but who did not undergo resection.

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Michael Hughes

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Long term follow up of previously randomised populations.

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: January 23, 2019
• Study Start: March 6, 2019
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)