Local Anesthetic Wound Infusion and Functional Recovery After Colon Surgery

August 3, 2015 updated by: Franco Carli

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3H1A4
        • Montreal General Hospital
      • Montreal, Quebec, Canada, H3H1V9
        • Montreal General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative functional recovery
Time Frame: at 24, 48, 72 hours, 4 and 8 weeks after the surgery
at 24, 48, 72 hours, 4 and 8 weeks after the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
postoperative pain
Time Frame: at 24, 48, 72 hours after the surgery
at 24, 48, 72 hours after the surgery
opioid consumption
Time Frame: at 24, 48, 72 hours after the surgery
at 24, 48, 72 hours after the surgery
opioid side effects
Time Frame: at 24, 48, 72 hours after the surgery
at 24, 48, 72 hours after the surgery
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.
at 24, 48, 72 hours after the surgery and continue at the same time everyday until patients have return of bowel function.
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.
at 24, 48, 72 hours after the surgery and continue at the same time everyday until the patients are discharged.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Franco Carli

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

February 3, 2010

First Posted (Estimate)

February 4, 2010

Study Record Updates

Last Update Posted (Estimate)

August 4, 2015

Last Update Submitted That Met QC Criteria

August 3, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEN-08-070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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