Peri-Operative Management of Patients Undergoing Laparoscopic Colorectal Surgery

NCT00747292 | Unknown Phase 1

• 1 other identifier: 07/H1111/70
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm; Diverticular Disease; Analgesia

Keywords

laparoscopic; colon; analgesia; fluid optimised

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  Once the patient is safe to go home

Secondary Outcomes (1)

• 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

Study Arms (3)

Epidural

ACTIVE COMPARATOR

Epidural

Procedure: epidural

2

ACTIVE COMPARATOR

Spinal

Procedure: Spinal

3

ACTIVE COMPARATOR

Patients in this limb receive a PCA

Procedure: PCA

Interventions

epidural PROCEDURE

Patients in this limb receive epidural analgesia

Epidural

PCA PROCEDURE

Patients in this limb receive a PCA for their pain control

3

Spinal PROCEDURE

Patients in limb will receive spinal analgesia

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minimal Access Therapy Training Unit: lead

Study Sites (1)

MATTU

Guildford, Surrey, GU2 9PS, United Kingdom

RECRUITING

Related Publications (4)

• 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.

  PMID: 14515286 BACKGROUND

• 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.

  PMID: 11391364 BACKGROUND

• 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.

  PMID: 17160649 BACKGROUND

• 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.

  PMID: 12437707 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Diverticular Diseases; Agnosia

Interventions

Injections, Epidural; Passive Cutaneous Anaphylaxis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena

Study Officials

• Tim Rockall, FRCS

  Minimal Access Therapy Training Unit

  STUDY DIRECTOR

Central Study Contacts

Bruce F Levy, MRCS

CONTACT

07769656842; brucelevy22@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 5, 2008
• Study Start: December 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: September 5, 2008

Record last verified: 2008-09

Locations

GB (1)