Novel Technique of Analgesia Following Open Liver Resection

University Health Network, Toronto

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Liver Resection

Treatments: Procedure: saline and IV PCA; Procedure: ropivacaine + iv PCA

Study type: Interventional

Funder types: Other

Identifiers

NCT01960049

12-0493-A

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

MOTAP Catheter with Saline and IV PCA

Placebo Comparator group

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

Treatment:

Procedure: saline and IV PCA

MOTAP catheter with ropivocaine and IV PCA

Active Comparator group

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

Treatment:

Procedure: ropivacaine + iv PCA