NCT01960049

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

Completed Phase 4 Last updated 28 July 2017

What this trial tests

Phase 4 trial testing ropivacaine + iv PCA in Postoperative Pain in 150 participants. Completed in 1 December 2016.

Timeline

1 October 2013

Primary endpoint
1 September 2016

1 December 2016

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	150
Start date	1 October 2013
Primary completion	1 September 2016
Estimated completion	1 December 2016
Sites	2 locations across Canada

Drugs / interventions tested

• ropivacaine + iv PCA
• saline and IV PCA

Conditions studied

• Postoperative Pain — all drugs for Postoperative Pain →
• Liver Resection — all drugs for Liver Resection →

Sponsor

University Health Network, Toronto

Who can join

18 and older, any sex, with Postoperative Pain or Liver Resection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 endpoi

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Medial open transversus abdominis plane (MOTAP) catheters for analgesia following open liver resection: study protocol for a randomized controlled trial.
   Karanicolas P, Cleary S, McHardy P, McCluskey S, et al · · 2014 · cited 6× · PMID 24950773 · DOI 10.1186/1745-6215-15-241