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

This study has been completed.
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh Identifier:
First received: November 28, 2012
Last updated: October 13, 2014
Last verified: October 2014
The investigators plan to compare epidurals versus wound catheters for effects on pain relief and recovery following open liver surgery.

Condition Intervention
Open Liver Resection Device: Wound catheter Device: Epidural

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

  • Molecular response to surgery [ Time Frame: Days 0, 1 and 3 ]
    HMGB1, RAGE and cytokines

  • Central Venous Pressure [ Time Frame: During liver transection ]
    Mean Central Venous Pressure during liver transection will be quantified and compared between groups.

  • Estimated Blood Loss [ Time Frame: Intra-operative ]
  • Operative field asessment [ Time Frame: During liver transection ]
  • Pringle time [ Time Frame: Intra-operative ]

Other Outcome Measures:
  • Quality of Life (EQ-5D) [ Time Frame: Pre-operative, 2 weeks post-operative, 4-6 weeks post-operative ]
  • Morphine consumption [ Time Frame: Day of surgery and postoperative days 1-7 ]
  • IV Fluid volume [ Time Frame: Day of Surgery and postoperative days 1-7 ]
  • Complications [ Time Frame: 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 ]

Enrollment: 97
Study Start Date: December 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wound catheter
Wound catheter
Device: Wound catheter
Wound catheter, placed at end of procedure, prior to closure. To be kept in for 48 hours.
Other Name: On-Q Painbuster
Active Comparator: Epidural
Standard epidural, pre-operative insertion, to be run for 48 hours
Device: Epidural


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01747122

United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Lothian, United Kingdom, EH16 4SA
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Principal Investigator: Michael J Hughes, MBChB University of Edinburgh
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Edinburgh Identifier: NCT01747122     History of Changes
Other Study ID Numbers: 2012/R/SU/01 - LIVER 2 Trial
Study First Received: November 28, 2012
Last Updated: October 13, 2014

Keywords provided by University of Edinburgh:
wound catheters
liver resection
liver surgery processed this record on September 21, 2017