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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Edinburgh
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01747122
First received: November 28, 2012
Last updated: May 19, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Visual analogue scores of pain experienced.

  • Molecular response to surgery [ Time Frame: Days 0, 1 and 3 ] [ Designated as safety issue: No ]
    HMGB1, RAGE and cytokines

  • Central Venous Pressure [ Time Frame: During liver transection ] [ Designated as safety issue: No ]
    Mean Central Venous Pressure during liver transection will be quantified and compared between groups.

  • Estimated Blood Loss [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
  • Operative field asessment [ Time Frame: During liver transection ] [ Designated as safety issue: No ]
  • Pringle time [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Quality of Life (EQ-5D) [ Time Frame: Pre-operative, 2 weeks post-operative, 4-6 weeks post-operative ] [ Designated as safety issue: No ]
  • Morphine consumption [ Time Frame: Day of surgery and postoperative days 1-7 ] [ Designated as safety issue: No ]
  • IV Fluid volume [ Time Frame: Day of Surgery and postoperative days 1-7 ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: day of surgery and post-operative days 1-30 ] [ Designated as safety issue: No ]
  • Post-operative blood tests (FBC, U&E, LFTs, coag) [ Time Frame: Post-operative days 1-7 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747122

Contacts
Contact: Michael J Hughes, MBChB 0131 242 3631 ext 23631 michaelh@doctors.net.uk

Locations
United Kingdom
Royal Infirmary of Edinburgh Recruiting
Edinburgh, Lothian, United Kingdom, EH16 4SA
Contact: Michael J Hughes, MBChB    0131 242 3631 ext 23631    michaelh@doctors.net.uk   
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
Principal Investigator: Michael J Hughes, MBChB University of Edinburgh
  More Information

Publications:
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01747122     History of Changes
Other Study ID Numbers: 2012/R/SU/01 - LIVER 2 Trial
Study First Received: November 28, 2012
Last Updated: May 19, 2014
Health Authority: Scotland: Academic and Clinical Central Office for Research and Development (ACCORD)

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

ClinicalTrials.gov processed this record on September 18, 2014