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Local Anesthetic Infusion and Sternotomy

18:25 EDT 16th April 2014 | BioPortfolio

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 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.

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: 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 :

- Group 1: Ropivacaïne infiltration before skin incision followed by a 48 hours Ropivacaïne continuous infusion after surgery through a sternal fenestrated catheter

- Group 2: same protocol with pre and postoperative saline infusion

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

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Hyperalgesia

Intervention

Local anesthetic (Ropivacaine), Saline

Location

Département d'Anesthésie-Réanimation II - Hôpital cardiologique - Groupe Hospitalier Sud, CHU de Bordeaux - 4, Av de Magella
Pessac
France
33604

Status

Recruiting

Source

University Hospital, Bordeaux

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

An increased sensation to painful stimuli that may follow damage to soft tissue containing NOCICEPTORS or injury to a peripheral nerve. Hyperalgesia can occur both at the site of tissue damage (primary hyperalgesia) and in the surrounding undamaged areas (secondary hyperalgesia). (Kandel et al., Principles of Neural Science, 3d ed, p386)

A local anesthetic of the amide type now generally used for surface anesthesia. It is one of the most potent and toxic of the long-acting local anesthetics and its parenteral use is restricted to spinal anesthesia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1006)

A widely used local anesthetic agent.

Acetanilide derivative used as a local anesthetic.

A thiophene-containing local anesthetic pharmacologically similar to MEPIVACAINE.

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