Status:
TERMINATED
Local Anesthetic Infusion and Sternotomy
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Hyperalgesia
Pain
Eligibility:
All Genders
50-75 years
Phase:
PHASE3
Brief Summary
Cardiac surgery often induces acute postoperative pain and moreover chronic dysesthesia frequently occur long-term after sternotomy. The high doses of intraoperative opioïds are well known to enhance ...
Detailed Description
* Principal Objective: comparison of peri-incisionnal dynamic hyperalgesia extend evaluated by Von Frey filament during the first postoperative week between the two groups. * Secondary Objective: comp...
Eligibility Criteria
Inclusion
- Patients aged from 50 to 75 years old
- ASA score : 1-3
- Cardiac surgery with median sternotomy for:
- single valve replacement, Bentall, Bahnson, Tyrone David procedure
- single or multiple Cardiac Artery Bypass Grafting (CABG)
- combined surgery (valve replacement + CABG)
- without predicted risk of postoperative complication
- Informed consent obtained from the patient
- Patient beneficiating of social insurance
Exclusion
- patient refusal to participate in the study
- Drug or alcohol abuse history
- Analgesic or opioid consumption within the 12 hours preceding the surgery
- Chronic use of analgesic drugs or history of chronic pain
- Disability to understand morphine PCA use
- Allergy to ropivacaine or other local anaesthesia
- Patient treated by fluvoxamine or enoxamine
- Patient suffering for liver insufficiency (child score \>A)
- Patient with major preoperative hypovolemia
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00802048
Start Date
February 1 2009
End Date
August 1 2010
Last Update
December 13 2011
Active Locations (1)
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1
Département d'Anesthésie-Réanimation II - Hôpital cardiologique - Groupe Hospitalier Sud, CHU de Bordeaux - 4, Av de Magellan
Pessac, France, 33604