Local Anesthetic Wound Infusion and Functional Recovery After Colon Surgery
NCT ID: NCT01062919
Last Updated: 2015-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2009-07-31
2013-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Franco Carli
OTHER
Responsible Party
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Franco Carli
Professor
Principal Investigators
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Franco Carli, Professor
Role: PRINCIPAL_INVESTIGATOR
McGill University Healt Centre
Locations
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Montreal General Hospital
Montreal, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Countries
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Other Identifiers
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GEN-08-070
Identifier Type: -
Identifier Source: org_study_id
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