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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
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00747292
Enrollment
99
Registered
2008-09-05
Start date
2007-12-31
Completion date
2009-10-31
Last updated
2008-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasm, Diverticular Disease, Analgesia

Keywords

laparoscopic, colon, analgesia, fluid optimised

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.

Interventions

PROCEDUREepidural

Patients in this limb receive epidural analgesia

PROCEDUREPCA

Patients in this limb receive a PCA for their pain control

PROCEDURESpinal

Patients in limb will receive spinal analgesia

Sponsors

Minimal Access Therapy Training Unit
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Length of hospital stayOnce the patient is safe to go home

Secondary

MeasureTime frame
Pain, time till flatus, time till bowels open, incidence of nausea and vomiting, quality of lifeOnce secondary outcomes are successful, patient can go home

Countries

United Kingdom

Contacts

Primary ContactBruce F Levy, MRCS
brucelevy22@hotmail.com07769656842

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026