NCT01747122

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

1.7 years

First QC Date

November 28, 2012

Last Update Submit

October 13, 2014

Conditions

Open Liver Resection

Keywords

epiduralswound cathetersliver resectionliver surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (6)

  • Pain Scores

    Performed daily at 0900 hours. On the day of surgery pain scores will be performed at 2, 6 and 12 hours post surgery.

  • Molecular response to surgery

    Days 0, 1 and 3

  • Central Venous Pressure

    During liver transection

  • Estimated Blood Loss

    Intra-operative

  • Operative field asessment

    During liver transection

  • +1 more secondary outcomes

Other Outcomes (5)

  • Quality of Life (EQ-5D)

    Pre-operative, 2 weeks post-operative, 4-6 weeks post-operative

  • Morphine consumption

    Day of surgery and postoperative days 1-7

  • IV Fluid volume

    Day of Surgery and postoperative days 1-7

  • +2 more other outcomes

Study Arms (2)

Wound catheter

EXPERIMENTAL

Wound catheter

Device: Wound catheter

Epidural

ACTIVE COMPARATOR

Standard epidural, pre-operative insertion, to be run for 48 hours

Device: Epidural

Interventions

Wound catheterDEVICE

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

Also known as: On-Q Painbuster
Wound catheter
EpiduralDEVICE
Epidural

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing open hepatic resection for benign or malignant conditions.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Lothian, EH16 4SA, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 22882198BACKGROUND

  • 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.

    PMID: 26447461DERIVED

MeSH Terms

Interventions

Injections, Epidural

Intervention Hierarchy (Ancestors)

Injections, SpinalInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Michael J Hughes, MBChB

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2012

First Posted

December 11, 2012

Study Start

December 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

GB(1)