The Effects of Local Infiltration Versus Epidural Following Liver Resection 2 (LIVER 2)

October 13, 2014 updated by: University of Edinburgh

A Randomised Trial of Peri-operative Nerve Block and Continuous Infusion of Local Anaesthetic Via Wound Catheter Versus Epidural in Patients Undergoing Open Liver Resection.

The investigators plan to compare epidurals versus wound catheters for effects on pain relief and recovery following open liver surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing open hepatic resection for benign or malignant conditions.

Exclusion Criteria:

  • Patients with contraindication to either epidural or wound catheter techniques.
  • Inability to give written, informed consent.
  • Jaundice (Bilirubin > 100 μmol/L)
  • Liver resection combined with secondary surgical procedure.
  • Age < 18 years
  • Pregnant women
  • patients on long term opiates for chronic pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Wound catheter
Device: Wound catheter
Wound catheter, placed at end of procedure, prior to closure. To be kept in for 48 hours.
Other Names:
  • On-Q Painbuster
ACTIVE_COMPARATOR: Epidural
Standard epidural, pre-operative insertion, to be run for 48 hours
Device: Epidural

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: Measurement made on day of discharge which is expected to be on average bewteen 5 and 10 days after surgery.
Number of days (to nearest half day) patients stay in hospital.
Measurement made on day of discharge which is expected to be on average bewteen 5 and 10 days after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores
Time Frame: Performed daily at 0900 hours. On the day of surgery pain scores will be performed at 2, 6 and 12 hours post surgery.
Visual analogue scores of pain experienced.
Performed daily at 0900 hours. On the day of surgery pain scores will be performed at 2, 6 and 12 hours post surgery.
Molecular response to surgery
Time Frame: Days 0, 1 and 3
HMGB1, RAGE and cytokines
Days 0, 1 and 3
Central Venous Pressure
Time Frame: During liver transection
Mean Central Venous Pressure during liver transection will be quantified and compared between groups.
During liver transection
Estimated Blood Loss
Time Frame: Intra-operative
Intra-operative
Operative field asessment
Time Frame: During liver transection
During liver transection
Pringle time
Time Frame: Intra-operative
Intra-operative

Other Outcome Measures

Outcome Measure
Time Frame
Quality of Life (EQ-5D)
Time Frame: Pre-operative, 2 weeks post-operative, 4-6 weeks post-operative
Pre-operative, 2 weeks post-operative, 4-6 weeks post-operative
Morphine consumption
Time Frame: Day of surgery and postoperative days 1-7
Day of surgery and postoperative days 1-7
IV Fluid volume
Time Frame: Day of Surgery and postoperative days 1-7
Day of Surgery and postoperative days 1-7
Complications
Time Frame: day of surgery and post-operative days 1-30
day of surgery and post-operative days 1-30
Post-operative blood tests (FBC, U&E, LFTs, coag)
Time Frame: Post-operative days 1-7
Post-operative days 1-7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

NHS Lothian

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

November 28, 2012

First Submitted That Met QC Criteria

December 10, 2012

First Posted (ESTIMATE)

December 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 13, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012/R/SU/01 - LIVER 2 Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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