Local Anesthetic Infusion and Sternotomy

Pain Clinical Trial

— CARDIODOLAL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00802048
• Other study ID #: CHUBX2007/26
• Status: Terminated
• Phase: Phase 3
• First received: December 3, 2008
• Last updated: December 12, 2011
• Start date: February 2009
• Est. completion date: August 2010

Study information

• Verified date: December 2011
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: August 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hyperalgesia
• Pain

Intervention

Drug:
• Local anesthetic (Ropivacaine)
Local anesthetic infusion
• Saline
Saline serum infusion

Locations

Country	Name	City	State
France	Département d'Anesthésie-Réanimation II - Hôpital cardiologique - Groupe Hospitalier Sud, CHU de Bordeaux - 4, Av de Magellan	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hyperalgesia area size around the cicatrix		24h after surgery	No
Secondary	Peroperative monitoring datas		Peroperative	Yes
Secondary	Dynamic hyperalgesia		Day 2, 3 and 6	No
Secondary	Static hyperalgesia		Day 1, 2, 3 and 6	No
Secondary	Ropivacaine plasmatic concentration		24h and 48h	Yes