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.

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.

Study Overview

• Status: Unknown
• Conditions: Analgesia; Neoplasm; Diverticular Disease
• Intervention / Treatment: Procedure: epidural; Procedure: Spinal; Procedure: PCA

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 Type: Interventional
• Enrollment (Anticipated): 99
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Bruce F Levy, MRCS; Phone Number: 07769656842; Email: brucelevy22@hotmail.com

Study Locations

• United Kingdom
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 9PS
      • Recruiting
      • MATTU
      • Contact: Bruce F Levy, MRCS; Phone Number: 07769656842; Email: brucelevy22@hotmail.com
      • Principal Investigator: Bruce F Levy, MRCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Epidural	Procedure: epidural; Patients in this limb receive epidural analgesia
ACTIVE_COMPARATOR: 2; Spinal	Procedure: Spinal; Patients in limb will receive spinal analgesia
ACTIVE_COMPARATOR: 3; Patients in this limb receive a PCA	Procedure: PCA; Patients in this limb receive a PCA for their pain control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay	Once the patient is safe to go home

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Minimal Access Therapy Training Unit
• Investigators: Study Director: Tim Rockall, FRCS, Minimal Access Therapy Training Unit

Publications and helpful links

General Publications

• Senagore AJ, Delaney CP, Mekhail N, Dugan A, Fazio VW. Randomized clinical trial comparing epidural anaesthesia and patient-controlled analgesia after laparoscopic segmental colectomy. Br J Surg. 2003 Oct;90(10):1195-9. doi: 10.1002/bjs.4223.
• Senagore AJ, Whalley D, Delaney CP, Mekhail N, Duepree HJ, Fazio VW. Epidural anesthesia-analgesia shortens length of stay after laparoscopic segmental colectomy for benign pathology. Surgery. 2001 Jun;129(6):672-6. doi: 10.1067/msy.2001.114648.
• Taqi A, Hong X, Mistraletti G, Stein B, Charlebois P, Carli F. Thoracic epidural analgesia facilitates the restoration of bowel function and dietary intake in patients undergoing laparoscopic colon resection using a traditional, nonaccelerated, perioperative care program. Surg Endosc. 2007 Feb;21(2):247-52. doi: 10.1007/s00464-006-0069-5. Epub 2006 Dec 9.
• Kong SK, Onsiong SM, Chiu WK, Li MK. Use of intrathecal morphine for postoperative pain relief after elective laparoscopic colorectal surgery. Anaesthesia. 2002 Dec;57(12):1168-73. doi: 10.1046/j.1365-2044.2002.02873.x.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (ANTICIPATED): October 1, 2009
• Study Completion (ANTICIPATED): October 1, 2009

Study Registration Dates

• First Submitted: September 4, 2008
• First Submitted That Met QC Criteria: September 4, 2008
• First Posted (ESTIMATE): September 5, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): September 5, 2008
• Last Update Submitted That Met QC Criteria: September 4, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: analgesia; colon; laparoscopic; fluid optimised
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Diverticulum; Diverticular Diseases
• Other Study ID Numbers: 07/H1111/70