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
|Condition or disease||Intervention/treatment||Phase|
|Open Liver Resection||Device: Wound catheter Device: Epidural||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Experimental: 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
- 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.
- 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 ]
- 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 ]
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
|Royal Infirmary of Edinburgh|
|Edinburgh, Lothian, United Kingdom, EH16 4SA|
|Principal Investigator:||Michael J Hughes, MBChB||University of Edinburgh|