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

NCT00823576 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-11-29

No results posted yet for this study

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.

Conditions

  • Postoperative Pain

Interventions

DRUG

Ropivacaine

Compare the evolution of the postoperative levels of pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving a single bolus of analgesic, one receiving a single bolus of analgesic and an infiltration of Ropivacaine during 48 hours.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • LITRICO LS Stéphane, PH · CHU de Nice - Hôpital Pasteur - 30 ave de la Voie Romaine - 06100 Nice

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-12-31
Completion
2011-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00823576 on ClinicalTrials.gov