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Low recruitment rate - >70% of colorectal procedures are done laparoscopically
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural analgesia group | Experimental | 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 Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural analgesia | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative functional recovery | at 24, 48, 72 hours, 4 and 8 weeks after the surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
ASA physical status 4
history of:
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
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| Name | Affiliation | Role |
|---|---|---|
| Franco Carli, Professor | McGill University Healt Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal General Hospital | Montreal | Quebec | H3H1A4 | Canada | ||
| Montreal General Hospital |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D015212 | Inflammatory Bowel Diseases |
| D004238 | Diverticulitis |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D015360 | Analgesia, Epidural |
| D013662 | Tea |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
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|
| Wound catheter | Procedure | 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. |
|
|
| 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. |
| Montreal |
| Quebec |
| H3H1V9 |
| Canada |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005759 | Gastroenteritis |
| D000076385 | Diverticular Diseases |
| D045424 |
| Complex Mixtures |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |