Local Anesthetic Wound Infusion and Functional Recovery After Colon Surgery

NCT ID: NCT01062919

Last Updated: 2015-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colon Cancer Inflammatory Bowel Diseases Diverticulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Epidural analgesia

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Wound catheter

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Thoracic epidural analgesia Wound catheter continuous infusion

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Franco Carli

OTHER

Sponsor Role lead

Responsible Party

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Franco Carli

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Franco Carli, Professor

Role: PRINCIPAL_INVESTIGATOR

McGill University Healt Centre

Locations

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Montreal General Hospital

Montreal, Quebec, Canada

Site Status

Montreal General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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GEN-08-070

Identifier Type: -

Identifier Source: org_study_id

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