Local Anesthetic Infusion and Sternotomy
TerminatedPhase 3NCT00802048
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Study of Effectiveness of a Ropivacaïne Continuous Sternal Infusion to Reduce Postoperative Hyperalgesia Induced by Sternotomy After Cardiac Surgery
- Conditions
- Interventions
- Drug: Local anesthetic (Ropivacaine)
- Drug: Saline
- Sponsor
- University Hospital, Bordeaux
- Start date
- 2009-02
- Primary completion
- 2010-01
- Sex
- All
- Age range
- from 50 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00802048