Local Anesthetic Wound Infusion and Functional Recovery After Colon Surgery

Not Applicable

Terminated

• Conditions: Inflammatory Bowel Diseases; Diverticulitis; Colon Cancer
• Interventions: Procedure: Wound catheter; Procedure: Epidural analgesia

• Registration Number: NCT01062919
• Lead Sponsor: Franco Carli

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.

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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-04
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wound Group	Wound catheter	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.
Epidural analgesia group	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.

Primary Outcome Measures

Name	Time	Method
Postoperative functional recovery	at 24, 48, 72 hours, 4 and 8 weeks after the surgery

Secondary Outcome Measures

Name	Time	Method
opioid side effects	at 24, 48, 72 hours after the surgery
postoperative pain	at 24, 48, 72 hours after the surgery
opioid consumption	at 24, 48, 72 hours after the surgery
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	at 24, 48, 72 hours after the surgery and continue at the same time everyday until the patients are discharged.

Trial Locations

Locations (1)

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada