Novel Technique of Analgesia Following Open Liver Resection

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960049
• Other study ID #: 12-0493-A
• Status: Completed
• Phase: Phase 4
• First received: September 23, 2013
• Last updated: July 28, 2017
• Start date: October 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Resection
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• ropivacaine + iv PCA

• saline and IV PCA

Locations

Country	Name	City	State
Canada	Sunnybrook Health Science Centre	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	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.