Local Anesthetic Wound Infusion and Functional Recovery After Colon Surgery

This study has suspended participant recruitment.
(Low recruitment rate - >70% of colorectal procedures are done laparoscopically)
Sponsor:
Information provided by (Responsible Party):
Franco Carli, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01062919
First received: September 22, 2009
Last updated: October 23, 2013
Last verified: October 2013

September 22, 2009
October 23, 2013
July 2009
November 2013   (final data collection date for primary outcome measure)
Postoperative functional recovery [ Time Frame: at 24, 48, 72 hours, 4 and 8 weeks after the surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01062919 on ClinicalTrials.gov Archive Site
  • postoperative pain [ Time Frame: at 24, 48, 72 hours after the surgery ] [ Designated as safety issue: No ]
  • opioid consumption [ Time Frame: at 24, 48, 72 hours after the surgery ] [ Designated as safety issue: Yes ]
  • opioid side effects [ Time Frame: at 24, 48, 72 hours after the surgery ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Local Anesthetic Wound Infusion and Functional Recovery After Colon Surgery
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
  • Colon Cancer
  • Inflammatory Bowel Diseases
  • Diverticulitis
  • 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
  • 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
  • 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.
    Intervention: Procedure: 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.
    Intervention: Procedure: Wound catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
50
December 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01062919
GEN-08-070
Yes
Franco Carli, McGill University Health Center
Franco Carli
Not Provided
Principal Investigator: Franco Carli, Professor McGill University Healt Centre
McGill University Health Center
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP