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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 postoperative hyperalgesia (HA) and a perioperative local anesthetic agent infusion is one of the therapeutic strategies used to limit this phenomena. The aim of this study was to evaluate the effectiveness of a continuous Ropivacaïne sternal infusion compared with a saline serum infusion to limit postoperative HA, pain and morphine consumption (M) after sternotomy in cardiac surgery.
This strategy could lead to lower postoperative morphine consumption and opioïd induced hyperalgesia.
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: comparison of peri-incisionnal static hyperalgesia (pain threshold) extend evaluated by Von Frey filament, postoperative pain scores, morphine consumption, hemodynamic and respiratory parameters during the first postoperative week and incidence of chronic pain and dysesthesia at six month between the two groups. Ropivacaïne plasmatic concentration will be monitored, during infusion.
Study design : monocentric, double blind randomized clinical trial comparing two groups of patients with a same intraoperative anesthetic management :
Postoperative pain management is identical in the two groups based upon a Morphine sulfate PCA pump for the first 48 hours.
• Number of subjects : 40 patients, 20 in each group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 48h postoperative infusion of ropivacaine |
|
| 2 | Placebo Comparator | 48h postoperative infusion of NaCl. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local anesthetic (Ropivacaine) | Drug | Local anesthetic infusion |
| |
| Saline |
| Measure | Description | Time Frame |
|---|---|---|
| hyperalgesia area size around the cicatrix | 24h after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Peroperative monitoring datas | Peroperative | |
| Dynamic hyperalgesia | Day 2, 3 and 6 | |
| Static hyperalgesia |
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Inclusion Criteria:
Patients aged from 50 to 75 years old
ASA score : 1-3
Cardiac surgery with median sternotomy for:
Informed consent obtained from the patient
Patient beneficiating of social insurance
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier POUQUET, Dr | University Hospital, Bordeaux | Principal Investigator |
| Antoine BENARD, Dr | University Hospital, Bordeaux | Study Chair |
| Mathieu LAFARGUE, MD | University Hospital, Bordeaux | Principal Investigator |
| Alexandre OUATTARA, MD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Département d'Anesthésie-Réanimation II - Hôpital cardiologique - Groupe Hospitalier Sud, CHU de Bordeaux - 4, Av de Magellan | Pessac | 33604 | France |
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| ID | Term |
|---|---|
| D006930 | Hyperalgesia |
| D010146 | Pain |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| Drug |
Saline serum infusion |
|
| Day 1, 2, 3 and 6 |
| Ropivacaine plasmatic concentration | 24h and 48h |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |