Clinical trial NCT01747122: The Effects of Local Infiltration Versus Epidural Following Liver Resection 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Liver Resection
Keywords: epidurals
wound catheters
liver resection
liver surgery
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2012-12-11
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Length of stay
timeFrame: Measurement made on day of discharge which is expected to be on average bewteen 5 and 10 days after surgery.
Secondary outcomes:
measure: Pain Scores
timeFrame: Performed daily at 0900 hours. On the day of surgery pain scores will be performed at 2, 6 and 12 hours post surgery.
measure: Molecular response to surgery
timeFrame: Days 0, 1 and 3
measure: Central Venous Pressure
timeFrame: During liver transection
measure: Estimated Blood Loss
timeFrame: Intra-operative
measure: Operative field asessment
timeFrame: During liver transection
measure: Pringle time
timeFrame: Intra-operative
Other outcomes:
measure: Quality of Life (EQ-5D)
timeFrame: Pre-operative, 2 weeks post-operative, 4-6 weeks post-operative
measure: Morphine consumption
timeFrame: Day of surgery and postoperative days 1-7
measure: IV Fluid volume
timeFrame: Day of Surgery and postoperative days 1-7
measure: Complications
timeFrame: day of surgery and post-operative days 1-30
measure: Post-operative blood tests (FBC, U&E, LFTs, coag)
timeFrame: Post-operative days 1-7
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Lothian
Study officials:
affiliation: University of Edinburgh
name: Michael J Hughes, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hughes MJ, Harrison EM, Peel NJ, Stutchfield B, McNally S, Beattie C, Wigmore SJ. Randomized clinical trial of perioperative nerve block and continuous local anaesthetic infiltration via wound catheter versus epidural analgesia in open liver resection (LIVER 2 trial). Br J Surg. 2015 Dec;102(13):1619-28. doi: 10.1002/bjs.9949. Epub 2015 Oct 8.