drugset / Trial / NCT02210260

Pain Relief After Colorectal Surgery: Spinal Combined With Painbuster® vs Painbuster® Alone.

NCT02210260

RandomizedParallel-groupDouble-blindTreatment

Summary

Limiting surgical stress and managing postoperative pain are well understood to influence recovery and outcome from major surgery for colorectal cancer and both are fundamental aspects of enhanced recovery protocols. Traditional approaches for dealing with these problems such as epidural or patient controlled intravenous opioid analgesia are associated with problems that may be detrimental to postoperative recovery and surgical outcome. As a result there is evidence in the literature of increasing interest in alternative techniques such as intrathecal anaesthesia or continuous wound infusion of local anaesthetic, however nobody has examined the effect of combining the techniques or their impact on the surgical stress response. We intend to compare patients undergoing major resections for colorectal cancer receiving intrathecal anaesthesia in combination with a wound infusion of local anaesthetic with those receiving a continuous wound infusion alone. We will examine the surgical stress response and postoperative pain control in addition to objective measures of postoperative recovery. We suggest that our approach will attenuate the surgical stress response and provide optimal pain control that will ultimately translate in improved recovery and outcome following surgery for colorectal cancer.

Timeline

Start
2013-09
Primary completion
2016-02
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.25 % Intrathecal
Subject Bupivacaine Other / unclassified 12.5 mg Intrathecal
Subject Bupivacaine Other / unclassified 20 ml Intrathecal
Subject Bupivacaine Other / unclassified 270 ml Intrathecal
Subject Diacetylmorphine Small molecule 500 ug Intrathecal

Indications