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Local Anesthetic Wound Infusion and Functional Recovery After Colon Surgery

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ClinicalTrials.gov Identifier: NCT01062919
Recruitment Status : Terminated (Low recruitment rate - >70% of colorectal procedures are done laparoscopically)
First Posted : February 4, 2010
Last Update Posted : August 4, 2015
Sponsor:
Information provided by (Responsible Party):
Franco Carli, McGill University Health Center

Brief Summary:

This is a double blinded randomized controlled trial in patients undergoing colon open surgery. The purpose is to evaluate the effectiveness of two different analgesic techniques on functional recovery after surgery.

Twenty five patients will receive thoracic epidural analgesia plus patient controlled analgesia (PCA) (epidural analgesia group) and 25 patients wound infiltration of local anesthetic plus PCA (wound infusion group).

Hypothesis: the postoperative recovery of patients receiving local anesthetic wound infusion will be faster than patients receiving thoracic epidural analgesia.

Functional recovery, pain intensity, opioid consumption and side effects, length of hospital stay and biological markers of inflammation after surgery will be measured in both groups.


Condition or disease Intervention/treatment
Colon Cancer Inflammatory Bowel Diseases Diverticulitis Procedure: Epidural analgesia Procedure: Wound catheter

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: Postoperative Determinants of Functional Recovery Following Colon Surgery: The Effect of Wound Infiltration With Local Anesthetics
Study Start Date : July 2009
Primary Completion Date : October 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Epidural analgesia group
patients in the epidural analgesia group will receive ropivacaine 0.2% through the epidural catheter, normal saline in the wound catheter and PCA with morphine.
Procedure: Epidural analgesia
patients in the epidural analgesia group will receive ropivacaine 0.2% through the epidural catheter, normal saline in the wound catheter and PCA with morphine.
Other Name: Thoracic epidural analgesia
Experimental: Wound Group
patients in the epidural analgesia group will receive ropivacaine 0.2% through the wound catheter, normal saline in the epidural catheter and PCA with morphine.
Procedure: Wound catheter
patients in the epidural analgesia group will receive 0.2%ropivacaine through the wound catheter, normal saline in the epidural catheter and PCA with morphine.
Other Name: Wound catheter continuous infusion



Primary Outcome Measures :
  1. Postoperative functional recovery [ Time Frame: at 24, 48, 72 hours, 4 and 8 weeks after the surgery ]

Secondary Outcome Measures :
  1. postoperative pain [ Time Frame: at 24, 48, 72 hours after the surgery ]
  2. opioid consumption [ Time Frame: at 24, 48, 72 hours after the surgery ]
  3. opioid side effects [ Time Frame: at 24, 48, 72 hours after the surgery ]
  4. return of bowel function [ Time Frame: at 24, 48, 72 hours after the surgery and continue at the same time everyday until patients have return of bowel function. ]
  5. length of hospital stay [ Time Frame: at 24, 48, 72 hours after the surgery and continue at the same time everyday until the patients are discharged. ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062919


Locations
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3H1A4
Montreal General Hospital
Montreal, Quebec, Canada, H3H1V9
Sponsors and Collaborators
Franco Carli
Investigators
Principal Investigator: Franco Carli, Professor McGill University Healt Centre

Responsible Party: Franco Carli, Professor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01062919     History of Changes
Other Study ID Numbers: GEN-08-070
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Diverticulitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Intraabdominal Infections
Infection
Anesthetics
Ropivacaine
Morphine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents