Local Anesthetic Infusion and Sternotomy (CARDIODOLAL)

Study of Effectiveness of a Ropivacaïne Continuous Sternal Infusion to Reduce Postoperative Hyperalgesia Induced by Sternotomy After Cardiac Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Pain; Hyperalgesia
• Intervention / Treatment: Drug: Local anesthetic (Ropivacaine); Drug: Saline

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: 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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; 48h postoperative infusion of ropivacaine	Drug: Local anesthetic (Ropivacaine); Local anesthetic infusion
Placebo Comparator: 2; 48h postoperative infusion of NaCl.	Drug: Saline; Saline serum infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
hyperalgesia area size around the cicatrix	24h after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Peroperative monitoring datas	Peroperative
Dynamic hyperalgesia	Day 2, 3 and 6
Static hyperalgesia	Day 1, 2, 3 and 6
Ropivacaine plasmatic concentration	24h and 48h

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Chair: Antoine BENARD, Dr, University Hospital, Bordeaux; Principal Investigator: Olivier POUQUET, Dr, University Hospital, Bordeaux; Principal Investigator: Mathieu LAFARGUE, MD, University Hospital, Bordeaux; Principal Investigator: Alexandre OUATTARA, MD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: December 3, 2008
• First Submitted That Met QC Criteria: December 3, 2008
• First Posted (Estimate): December 4, 2008

Study Record Updates

• Last Update Posted (Estimate): December 13, 2011
• Last Update Submitted That Met QC Criteria: December 12, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Cardiac surgery; Chronic; Postoperative pain; Sternotomy; Cardiac surgical procedures; Ropivacaïne; Postoperative hyperalgesia; Intralesional anesthetic infusion; Sternum
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Somatosensory Disorders; Hyperalgesia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: CHUBX2007/26