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Randomised Controlled Trial Comparing the Effects of Epidural, Spinal and PCA in Patients Undergoing Laparoscopic Colectomy.

Phase 1/Phase 2
18 Years
Open (Enrolling)
Neoplasm, Diverticular Disease, Analgesia

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Trial Information

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.

Inclusion Criteria:

- Patients with colorectal disease that requires a bowel resection who agree to have
laparoscopic surgery with placement of an oesophageal doppler and a central line and
who agree to be randomised with regards to a post operative analgesic regime.

Exclusion Criteria:

- Patients will be excluded from the post operative analgesia trial if they have
abnormal clotting, skin infection over or near the back, presence of neurological
disorders or anatomical abnormalities of the vertebral column, or for a reason
identified by the anaesthetist.

- Patients will also be excluded if there is a contra-indication to oesophageal doppler
such as oesophageal disease, recent oesophageal or upper airway surgery, moderate to
severe aortic valve disease and bleeding diathesis.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Length of hospital stay

Outcome Time Frame:

Once the patient is safe to go home

Safety Issue:


Principal Investigator

Tim Rockall, FRCS

Investigator Role:

Study Director

Investigator Affiliation:

Minimal Access Therapy Training Unit


United Kingdom: Research Ethics Committee

Study ID:




Start Date:

December 2007

Completion Date:

October 2009

Related Keywords:

  • Neoplasm
  • Diverticular Disease
  • Analgesia
  • laparoscopic
  • colon
  • analgesia
  • fluid optimised
  • Neoplasms
  • Diverticulum