Colon Cancer Clinical Trial
Official title:
Postoperative Determinants of Functional Recovery Following Colon Surgery: The Effect of Wound Infiltration With Local Anesthetics
This is a double blinded randomized controlled trial in patients undergoing colon open
surgery. The purpose is to evaluate the effectiveness of two different analgesic techniques
on functional recovery after surgery.
Twenty five patients will receive thoracic epidural analgesia plus patient controlled
analgesia (PCA) (epidural analgesia group) and 25 patients wound infiltration of local
anesthetic plus PCA (wound infusion group).
Hypothesis: the postoperative recovery of patients receiving local anesthetic wound infusion
will be faster than patients receiving thoracic epidural analgesia.
Functional recovery, pain intensity, opioid consumption and side effects, length of hospital
stay and biological markers of inflammation after surgery will be measured in both groups.
This is double blinded randomised study of patients undergoing colon open surgery. One group of patients will receive thoracic epidural analgesia plus patient controlled analgesia (PCA) (epidural analgesia group) and the other group will receive infiltration of local anesthetic plus PCA (wound infusion group). Functional restoration, assessed by self-administered quality of Life questionnaires (SF-36, CHAMPS, ICFS) and 2 and 6 min walking test will be assessed in the two groups at 3 and 8 weeks after the surgery. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)
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