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Local Anesthetic Wound Infusion and Functional Recovery After Colon Surgery

Sponsor
Franco Carli (Other)
Overall Status
Terminated
CT.gov ID
NCT01062919
Collaborator
(none)
10
Enrollment
2
Locations
2
Arms
51
Duration (Months)
5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Procedure: Epidural analgesia
  • Procedure: Wound catheter
 N/A

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 Design

Study Type:
Interventional
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 :
Jul 1, 2009
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Oct 1, 2013

Arms and Interventions

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 Names:
  • 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 Names:
  • Wound catheter continuous infusion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative functional recovery [at 24, 48, 72 hours, 4 and 8 weeks after the surgery]

    Secondary Outcome Measures

    1. postoperative pain [at 24, 48, 72 hours after the surgery]

    2. opioid consumption [at 24, 48, 72 hours after the surgery]

    3. opioid side effects [at 24, 48, 72 hours after the surgery]

    4. return of bowel function [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 [at 24, 48, 72 hours after the surgery and continue at the same time everyday until the patients are discharged.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Montreal General Hospital Montreal Quebec Canada H3H1A4
    2 Montreal General Hospital Montreal Quebec Canada H3H1V9

    Sponsors and Collaborators

    • Franco Carli

    Investigators

    • Principal Investigator: Franco Carli, Professor, McGill University Healt Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Franco Carli, Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
    ClinicalTrials.gov Identifier:
    NCT01062919
    Other Study ID Numbers:
    • GEN-08-070
    First Posted:
    Feb 4, 2010
    Last Update Posted:
    Aug 4, 2015
    Last Verified:
    Aug 1, 2015
    Additional relevant MeSH terms:
    Inflammatory Bowel Diseases
    Diverticulitis

    Study Results

    No Results Posted as of Aug 4, 2015