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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01747122
First Posted: December 11, 2012
Last Update Posted: October 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh
  Purpose
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

  Eligibility

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747122


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01747122     History of Changes
Other Study ID Numbers: 2012/R/SU/01 - LIVER 2 Trial
First Submitted: November 28, 2012
First Posted: December 11, 2012
Last Update Posted: October 15, 2014
Last Verified: October 2014

Keywords provided by University of Edinburgh:
epidurals
wound catheters
liver resection
liver surgery