Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery

Phase 1

• Conditions: Neoplasm; Diverticular Disease; Analgesia
• Interventions: Procedure: PCA; Procedure: epidural; Procedure: Spinal

• Registration Number: NCT00747292
• Lead Sponsor: Minimal Access Therapy Training Unit

Brief 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.

Study Timeline

• Study Start: 2007-12
• Status Verified: 2008-09
• Study First Submitted: 2008-09-04
• Study First Submitted QC: 2008-09-04
• Last Update Submitted: 2008-09-04
• Study First Posted: 2008-09-05
• Last Update Posted: 2008-09-05
• Primary Completion: 2009-10
• Study Completion: 2009-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	PCA	Patients in this limb receive a PCA
Epidural	epidural	Epidural
2	Spinal	Spinal

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	Once the patient is safe to go home

Secondary Outcome Measures

Name	Time	Method
Pain, time till flatus, time till bowels open, incidence of nausea and vomiting, quality of life	Once secondary outcomes are successful, patient can go home

Trial Locations

Locations (1)

MATTU; 🇬🇧 Guildford, Surrey, United Kingdom