Novel Technique of Analgesia Following Open Liver Resection

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Pain, Liver Resection

Intervention / Treatment
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* Procedure: ropivacaine + iv PCA
* Procedure: saline and IV PCA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: MOTAP Catheter with Saline and IV PCA<br>Control group will have saline 20cc of 0.9% normal saline injected into the catheters and then run at 5ml/hr for 72 hours | Procedure: saline and IV PCA<br> <br> |
| Active Comparator: MOTAP catheter with ropivocaine and IV PCA<br>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 | Procedure: ropivacaine + iv PCA<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Liver resection, Medial Open Transversus Abdominis Plane catheter