Epidural vs. Wound Catheter Following Liver Resection

August 16, 2018 updated by: The Leeds Teaching Hospitals NHS Trust

Good postoperative pain control after any major surgery allows early mobilization, minimises postoperative complications and reduces patient distress. Multiple different methods of delivering analgesia have been described.

This study aims to compare postoperative pain control between patients with epidural analgesia versus the combination of continuous infiltration of local anaesthetic with wound catheters, TAP block and IV PCA with opiate analgesia following open liver resection. The investigators expect that pain control will be similar between the two groups but that the utilization of wound catheters will confer benefit due to the lack of systemic side effects associated with epidural analgesia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leeds, United Kingdom, LS1 3HE,
        • Leeds Teaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All adult patients scheduled to undergo an open liver resection at this hospital will be eligible to participate.

Exclusion Criteria:

  • Patients with a contraindication to either epidural or wound catheter
  • Inability to give written, informed consent
  • Aged less than 18 years old
  • Liver resection combined with a secondary surgical procedure
  • Body mass index of <18 or >40
  • Pregnancy or lactation
  • A history of chronic pain requiring regular opioid analgesia
  • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard treatment
Active Comparator: Intervention arm
Procedure: This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA.
This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The length of hospital stay following open liver resection
Time Frame: 6 months (or length of the study)
6 months (or length of the study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Leeds Teaching Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2014

Primary Completion (Actual)

October 5, 2015

Study Completion (Actual)

October 5, 2015

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

August 16, 2018

First Posted (Actual)

August 20, 2018

Study Record Updates

Last Update Posted (Actual)

August 20, 2018

Last Update Submitted That Met QC Criteria

August 16, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RL14/11048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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