Local Anesthetic Wound Infusion and Functional Recovery After Colon Surgery

Study Overview
=================
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.

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

Conditions
-----------------
Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis

Intervention / Treatment
-----------------
* Procedure: Epidural analgesia
* Procedure: Wound catheter


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidural analgesia group<br>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<br>* 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.<br>* Other names: Thoracic epidural analgesia;|
| Experimental: Wound Group<br>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<br>* 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.<br>* Other names: Wound catheter continuous infusion;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain |  | at 24, 48, 72 hours after the surgery | 
| opioid consumption |  | at 24, 48, 72 hours after the surgery | 
| opioid side effects |  | 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. |