Novel Technique of Analgesia Following Open Liver Resection

July 28, 2017 updated by: University Health Network, Toronto

Multicentre Evaluation of a Novel Technique of Analgesia Following Open Liver Resection: Medial Open Transversus Abdominis Plane (MOTAP) Catheters

Abdominal wall incisions used for liver surgeries are associated with significant postoperative pain and disability. Epidural analgesia is often contraindicated in these patients due to common bleeding problems. Furthermore, drugs such as acetaminophen and opioids are often inadequate and can lead to detrimental side-effects. Abdominal wall (AW) catheters can be placed during surgical closure along the incision line and can be used to administer local anesthetics for postoperative pain. The study is a multi-centre, double-blind, randomized controlled trial involving 120 patients undergoing elective liver surgery. Patients will be randomly assigned to AW catheter group treated with drug or control treated with saline. Treatment group will receive AW catheters with ropivacaine plus standard patient controlled analgesia (PCA). Control group will obtain AW with normal saline and no local anesthetics and PCA. Patients are followed for 6 months post-operatively for pain scores, side-effects, chronic pain and complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
      • Toronto, Ontario, Canada
        • Sunnybrook Health Science Centre

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >18 years age
  • Undergoing liver resection using a subcostal incision

Exclusion Criteria:

  • Patients unable to comprehend instructions, consent, or co-operate with pain assessment (including psychiatric disorders, pre-operative sedation, coma)
  • Allergy to any study medications
  • Patient not able to be extubated postoperatively for any clinical reason
  • Laparoscopic surgery
  • Co-existing epidural or intrathecal analgesia
  • Chronic pain disorders or on long-term opioid use
  • History of substance or alcohol abuse
  • Transplant donor liver resections
  • Patients with liver cirrhosis

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: MOTAP Catheter with Saline and IV PCA
Control group will have saline 20cc of 0.9% normal saline injected into the catheters and then run at 5ml/hr for 72 hours
Procedure: saline and IV PCA
Active Comparator: MOTAP catheter with ropivocaine and IV PCA
20cc of 0.2% ropivacaine will be injected in two equal divided doses through the two catheters then run at 5ml/hr for 72 hours
Procedure: ropivacaine + iv PCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: PCA opioid consumption every 12 hours for 72 hours as well as total opioid consumption for the entire hospital stay.

The primary endpoint is mean cumulative postoperative opioid consumption over the first two postoperative days (48 hours). Both intravenous PCA opioids and oral opioids will be recorded from the patient's medical records daily, converted to morphine equivalents, and compared between the two groups.

The following information will be collected at regular intervals as a measure of the primary endpoints: Cumulative i.v. PCA opioid consumption every 12 hours for 72 hours as well as total opioid consumption for the entire hospital stay.
PCA opioid consumption every 12 hours for 72 hours as well as total opioid consumption for the entire hospital stay.

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Hance Clarke, MD, Toronto General Hospital, University Health Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 23, 2013

First Submitted That Met QC Criteria

October 4, 2013

First Posted (Estimate)

October 10, 2013

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 28, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-0493-A

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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