The Effects of Local Infiltration Versus Epidural Following Liver Resection 2

Open Liver Resection Clinical Trial

— LIVER 2  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01747122
• Other study ID #: 2012/R/SU/01 - LIVER 2 Trial
• Status: Completed
• Phase: N/A
• First received: November 28, 2012
• Last updated: October 13, 2014
• Start date: December 2012
• Est. completion date: August 2014

Study information

• Verified date: October 2014
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Scotland: Academic and Clinical Central Office for Research and Development (ACCORD)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Open Liver Resection

Intervention

Device:
• Wound catheter
Wound catheter, placed at end of procedure, prior to closure. To be kept in for 48 hours.
• Epidural

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh	Lothian

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Revie EJ, McKeown DW, Wilson JA, Garden OJ, Wigmore SJ. Randomized clinical trial of local infiltration plus patient-controlled opiate analgesia vs. epidural analgesia following liver resection surgery. HPB (Oxford). 2012 Sep;14(9):611-8. doi: 10.1111/j.1477-2574.2012.00490.x. Epub 2012 Jun 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life (EQ-5D)		Pre-operative, 2 weeks post-operative, 4-6 weeks post-operative	No
Other	Morphine consumption		Day of surgery and postoperative days 1-7	No
Other	IV Fluid volume		Day of Surgery and postoperative days 1-7	No
Other	Complications		day of surgery and post-operative days 1-30	No
Other	Post-operative blood tests (FBC, U&E, LFTs, coag)		Post-operative days 1-7	No
Primary	Length of stay	Number of days (to nearest half day) patients stay in hospital.	Measurement made on day of discharge which is expected to be on average bewteen 5 and 10 days after surgery.	No
Secondary	Pain Scores	Visual analogue scores of pain experienced.	Performed daily at 0900 hours. On the day of surgery pain scores will be performed at 2, 6 and 12 hours post surgery.	No
Secondary	Molecular response to surgery	HMGB1, RAGE and cytokines	Days 0, 1 and 3	No
Secondary	Central Venous Pressure	Mean Central Venous Pressure during liver transection will be quantified and compared between groups.	During liver transection	No
Secondary	Estimated Blood Loss		Intra-operative	No
Secondary	Operative field asessment		During liver transection	No
Secondary	Pringle time		Intra-operative	No