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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
  Purpose

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 Intervention
Colon Cancer
Inflammatory Bowel Diseases
Diverticulitis
Procedure: Epidural analgesia
Procedure: Wound catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Postoperative Determinants of Functional Recovery Following Colon Surgery: The Effect of Wound Infiltration With Local Anesthetics

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Postoperative functional recovery [ Time Frame: at 24, 48, 72 hours, 4 and 8 weeks after the surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: July 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Franco Carli, Professor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01062919     History of Changes
Other Study ID Numbers: GEN-08-070
Study First Received: September 22, 2009
Last Updated: October 23, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Diverticulitis
Inflammatory Bowel Diseases
Intestinal Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Infection
Intraabdominal Infections
Anesthetics
Anesthetics, Local
Ropivacaine
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014