Liver Resection, Postoperative Pain
Conditions
Keywords
Postoperative pain, Liver resection, Medial Open Transversus Abdominis Plane catheter
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.
Interventions
PROCEDUREropivacaine + iv PCA
PROCEDUREsaline and IV PCA
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | PCA opioid consumption every 12 hours for 72 hours as well as total opioid consumption for the entire hospital stay. | 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. |
Countries
Canada
Outcome results
None listed