Overview

This trial is active, not recruiting.

Conditions postoperative pain, liver resection
Treatments ropivacaine + iv pca, saline and iv pca
Phase phase 4
Sponsor University Health Network, Toronto
Start date October 2013
End date September 2016
Trial size 150 participants
Trial identifier NCT01960049, 12-0493-A

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Control group will have saline 20cc of 0.9% normal saline injected into the catheters and then run at 5ml/hr for 72 hours
saline and iv pca
(Active Comparator)
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
ropivacaine + iv pca

Primary Outcomes

Measure
Opioid consumption
time frame: 72 hours and 5 days (average HLOS)
Pain
time frame: 3 tiiems daily for 48 hours then daily until discharge ( 5 day average)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Multicentre Evaluation of a Novel Technique of Analgesia Following Open Liver Resection: Medial Open Transversus Abdominis Plane (MOTAP) Catheters
Principal investigator Hance Clarke, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.