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Postoperative Determinants of Functional Recovery Following Colon Surgery: The Effect of Wound Infiltration With Local Anesthetics


N/A
18 Years
85 Years
Open (Enrolling)
Both
Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis

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Trial Information

Postoperative Determinants of Functional Recovery Following Colon Surgery: The Effect of Wound Infiltration With Local Anesthetics


This is double blinded randomised study of patients undergoing colon open surgery. One group
of patients will receive thoracic epidural analgesia plus patient controlled analgesia (PCA)
(epidural analgesia group) and the other group will receive infiltration of local anesthetic
plus PCA (wound infusion group). Functional restoration, assessed by self-administered
quality of Life questionnaires (SF-36, CHAMPS, ICFS) and 2 and 6 min walking test will be
assessed in the two groups at 3 and 8 weeks after the surgery.


Inclusion Criteria:



- patients undergoing elective open colon surgery

Exclusion Criteria:

- ASA physical status 4

- history of:

- hepatic failure (liver enzymes abnormally elevated)

- renal failure (creatinine over 150 mmol/L)

- cardiac failure

- organ transplant

- diabetes

- morbid obesity (BMI > 40 kg/m-2)

- chronic use of opioids

- allergy to local anaesthetics

- History of seizure

- contraindications to the insertion of epidural

- INR > 1.3, PTT > 44 second, platelets < 150.000 per microliter,

- previous spinal surgery limiting the insertion)

- inability to comprehend pain assessment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Outcome Measure:

Postoperative functional recovery

Outcome Time Frame:

at 24, 48, 72 hours, 4 and 8 weeks after the surgery

Safety Issue:

No

Principal Investigator

Franco Carli, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

McGill University Healt Centre

Authority:

Canada: Ethics Review Committee

Study ID:

GEN-08-070

NCT ID:

NCT01062919

Start Date:

July 2009

Completion Date:

December 2010

Related Keywords:

  • Colon Cancer
  • Inflammatory Bowel Diseases
  • Diverticulitis
  • Colonic Neoplasms
  • Diverticulitis
  • Inflammatory Bowel Diseases
  • Intestinal Diseases

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