NCT00747292

Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Minimal Access Therapy Training Unit · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim is to ascertain which method out of epidural, spinal or patient controlled analgesia (PCA) is the most appropriate in fluid optimised patients after laparoscopic colorectal surgery in terms of pain control, length of hospital stay and time for gut recovery. The second aim is to assess the physiological changes that occur when the patient is placed in steep trendelenberg position together with the creation of the pneumoperitoneum.

Detailed description

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.

Conditions

• Neoplasm
• Diverticular Disease
• Analgesia

Interventions

Type	Name	Description
PROCEDURE	epidural	Patients in this limb receive epidural analgesia
PROCEDURE	PCA	Patients in this limb receive a PCA for their pain control
PROCEDURE	Spinal	Patients in limb will receive spinal analgesia

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-09-05
• Last updated: 2008-09-05

Locations

1 site across 1 country: United Kingdom