Novel Technique of Analgesia Following Open Liver Resection

Phase 4

Completed

• Conditions: Postoperative Pain; Liver Resection
• Interventions: Procedure: saline and IV PCA; Procedure: ropivacaine + iv PCA

• Registration Number: NCT01960049
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-23
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-04
• Study First Posted: 2013-10-10
• Status Verified: 2016-05
• Primary Completion: 2016-09
• Study Completion: 2016-12
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MOTAP Catheter with Saline and IV PCA	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
MOTAP catheter with ropivocaine and IV PCA	ropivacaine + 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

Primary Outcome Measures

Name	Time	Method
Opioid consumption	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.

Trial Locations

Locations (2)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook Health Science Centre; 🇨🇦 Toronto, Ontario, Canada