Local Anesthetic Wound Infusion and Functional Recovery After Colon Surgery

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01062919
• Other study ID #: GEN-08-070
• Status: Terminated
• Phase: N/A
• First received: September 22, 2009
• Last updated: August 3, 2015
• Start date: July 2009
• Est. completion date: October 2013

Study information

• Verified date: August 2015
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Colon Cancer
• Diverticulitis
• Inflammatory Bowel Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Franco Carli

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative functional recovery		at 24, 48, 72 hours, 4 and 8 weeks after the surgery	No
Secondary	postoperative pain		at 24, 48, 72 hours after the surgery	No
Secondary	opioid consumption		at 24, 48, 72 hours after the surgery	Yes
Secondary	opioid side effects		at 24, 48, 72 hours after the surgery	Yes
Secondary	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.	No
Secondary	length of hospital stay		at 24, 48, 72 hours after the surgery and continue at the same time everyday until the patients are discharged.	No