Novel Technique of Analgesia Following Open Liver Resection
Primary Purpose
Postoperative Pain, Liver Resection
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
ropivacaine + iv PCA
saline and IV PCA
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, Liver resection, Medial Open Transversus Abdominis Plane catheter
Eligibility Criteria
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
Sites / Locations
- Toronto General Hospital
- Sunnybrook Health Science Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
MOTAP Catheter with Saline and IV PCA
MOTAP catheter with ropivocaine and IV PCA
Arm Description
Control group will have saline 20cc of 0.9% normal saline injected into the catheters and then run at 5ml/hr for 72 hours
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01960049
First Posted
September 23, 2013
Last Updated
July 28, 2017
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT01960049
Brief Title
Novel Technique of Analgesia Following Open Liver Resection
Official Title
Multicentre Evaluation of a Novel Technique of Analgesia Following Open Liver Resection: Medial Open Transversus Abdominis Plane (MOTAP) Catheters
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Liver Resection
Keywords
Postoperative pain, Liver resection, Medial Open Transversus Abdominis Plane catheter
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MOTAP Catheter with Saline and IV PCA
Arm Type
Placebo Comparator
Arm Description
Control group will have saline 20cc of 0.9% normal saline injected into the catheters and then run at 5ml/hr for 72 hours
Arm Title
MOTAP catheter with ropivocaine and IV PCA
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
ropivacaine + iv PCA
Intervention Type
Procedure
Intervention Name(s)
saline and IV PCA
Primary Outcome Measure Information:
Title
Opioid consumption
Description
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.
Time Frame
PCA opioid consumption every 12 hours for 72 hours as well as total opioid consumption for the entire hospital stay.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hance Clarke, MD
Organizational Affiliation
Toronto General Hospital, University Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
30298685
Citation
Page MG, Karanicolas PJ, Cleary S, Wei AC, McHardy P, Ladak SSJ, Ayach N, Sawyer J, McCluskey SA, Srinivas C, Katz J, Coburn N, Hallet J, Law C, Greig P, Clarke H. In-hospital opioid consumption, but not pain intensity scores, predicts 6-month levels of pain catastrophizing following hepatic resection: A trajectory analysis. Eur J Pain. 2019 Mar;23(3):503-514. doi: 10.1002/ejp.1324. Epub 2018 Nov 8.
Results Reference
derived
PubMed Identifier
29300708
Citation
Karanicolas PJ, Cleary S, McHardy P, Kiss A, Sawyer J, Behman R, Ladak S, McCluskey SA, Srinivas C, Katz J, Coburn N, Law C, Wei AC, Greig P, Hallet J, Clarke H. Medial Open Transversus Abdominis Plane (MOTAP) Catheters Reduce Opioid Requirements and Improve Pain Control Following Open Liver Resection: A Multicenter, Blinded, Randomized Controlled Trial. Ann Surg. 2018 Aug;268(2):233-240. doi: 10.1097/SLA.0000000000002657.
Results Reference
derived
PubMed Identifier
24950773
Citation
Karanicolas P, Cleary S, McHardy P, McCluskey S, Sawyer J, Ladak S, Law C, Wei A, Coburn N, Ko R, Katz J, Kiss A, Khan J, Coimbatore S, Lam-McCulloch J, Clarke H. Medial open transversus abdominis plane (MOTAP) catheters for analgesia following open liver resection: study protocol for a randomized controlled trial. Trials. 2014 Jun 21;15:241. doi: 10.1186/1745-6215-15-241.
Results Reference
derived
Learn more about this trial
Novel Technique of Analgesia Following Open Liver Resection
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