Randomised Controlled Trial Comparing the Effects of Epidural, Spinal and PCA in Patients Undergoing Laparoscopic Colectomy.
Patients will be randomized into one of 3 groups - A, B or C. In order to remove the major
confounding factor of hypovolaemia, all patients will have an oesophageal doppler inserted
in order to achieve fluid optimisation. Each group will then either have an epidural, spinal
or a PCA for post operative analgesia depending on the randomisation. All patients will
follow a common postoperative care pathway to standardize the other factors.
Patients will be asked to report parameters including pain visual analogue score (VAS) chart
three times a day. Recovery of bowel functions (passage of flatus, bowel movement, and diet
intake), additional analgesia consumption, time to first ambulation, analgesia related
side-effects and time to discharge will be recorded.
In addition whilst the patients fluid status is optimized during surgery with the
oesophageal Doppler, the physiological changes that occur with the steep trendelenberg
position and the pneumoperitoneum will be recorded.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Length of hospital stay
Once the patient is safe to go home
Yes
Tim Rockall, FRCS
Study Director
Minimal Access Therapy Training Unit
United Kingdom: Research Ethics Committee
07/H1111/70
NCT00747292
December 2007
October 2009
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