Efficacy of Ropivacaine Continuous Wound Instillation Versus Single Shot After Spine Fusion Surgery

• Status: Terminated
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Because local anesthetic infiltration has not been comparated to continuous infusion after spine fusion surgery, the investigators designed this study to determine whether this technique could enhance analgesia and improve patient outcome after posterior lumbar arthrodesis.

The Main Objective of the study is to compare the evolution of the postoperative levels of pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving an infiltration "single shot" of local analgesic (Ropivacaïne), one receiving a single shot infiltration and a continuous infiltration of Ropivacaine during 48 hours.

In both groups the wound was infiltrated with a solution of ropivacaine 0.5% 200 mg/40 mL, and in one group an infusion of ropivacaine 0.2% 5 mL/h was maintained for 48 h.

The secondary outcomes are the consumption of morphine,the rate of the nausea and the postoperative vomits, the delay up to the first rise, the quality of the sleep, the duration of hospital stay and the persistence of residual pain.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nice
• Treatments: Analgesics; Ropivacaine

Criteria

Inclusion Criteria:

• Patients benefiting from of arthrodesis scheduled by a rachis lumbar posterior way

• Older than 18 years old

• Heavier than 50 kg

• Patients in the state health scheme

• Patients having signed consent

Exclusion Criteria:

• Surgery linked to an infectious, tumoral or traumatological cause

• Patients suffering of chronic pain define as patients consuming stage 3 analgesic since more than 3 months.- Patients receiving isoptine or flécaïne before surgery

• Arthrodesis on more than 3 stages

• Impossibility of cooperate with the patient

• Contra-indication for the maintain or the installation of a catheter diffusing analgesic

• Contra-indication of using local analgesic