The Effects of Local Infiltration Versus Epidural Following Liver Resection 2

NCT ID: NCT01747122

Last Updated: 2014-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-08-31

Brief Summary

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

Detailed Description

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Conditions

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Open Liver Resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Wound catheter

Wound catheter

Group Type EXPERIMENTAL

Wound catheter

Intervention Type DEVICE

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

Epidural

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

Group Type ACTIVE_COMPARATOR

Epidural

Intervention Type DEVICE

Interventions

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Wound catheter

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

Intervention Type DEVICE

Epidural

Intervention Type DEVICE

Other Intervention Names

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On-Q Painbuster

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Lothian

OTHER_GOV

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael J Hughes, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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Royal Infirmary of Edinburgh

Edinburgh, Lothian, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 22882198 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26447461 (View on PubMed)

Other Identifiers

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2012/R/SU/01 - LIVER 2 Trial

Identifier Type: -

Identifier Source: org_study_id

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