Novel Technique of Analgesia Following Open Liver Resection
This trial is active, not recruiting.
|Conditions||postoperative pain, liver resection|
|Treatments||ropivacaine + iv pca, saline and iv pca|
|Sponsor||University Health Network, Toronto|
|Start date||October 2013|
|End date||September 2016|
|Trial size||150 participants|
|Trial identifier||NCT01960049, 12-0493-A|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
time frame: 72 hours and 5 days (average HLOS)
time frame: 3 tiiems daily for 48 hours then daily until discharge ( 5 day average)
Male or female participants at least 18 years old.
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
|Official title||Multicentre Evaluation of a Novel Technique of Analgesia Following Open Liver Resection: Medial Open Transversus Abdominis Plane (MOTAP) Catheters|
|Principal investigator||Hance Clarke, MD|
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