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

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ClinicalTrials.gov Identifier: NCT01747122
Recruitment Status : Completed
First Posted : December 11, 2012
Last Update Posted : October 15, 2014
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

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

Condition or disease Intervention/treatment
Open Liver Resection Device: Wound catheter Device: Epidural

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
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.
Study Start Date : December 2012
Primary Completion Date : August 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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.

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

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

  4. Estimated Blood Loss [ Time Frame: Intra-operative ]
  5. Operative field asessment [ Time Frame: During liver transection ]
  6. Pringle time [ Time Frame: Intra-operative ]

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

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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

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

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