Novel Technique of Analgesia Following Open Liver Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-12-31

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.

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Detailed Description

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Conditions

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Postoperative Pain Liver Resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MOTAP Catheter with 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

Group Type PLACEBO_COMPARATOR

saline and IV PCA

Intervention Type PROCEDURE

MOTAP catheter with ropivocaine and 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

Group Type ACTIVE_COMPARATOR

ropivacaine + iv PCA

Intervention Type PROCEDURE

Interventions

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ropivacaine + iv PCA

Intervention Type PROCEDURE

saline and IV PCA

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No