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

This study has been terminated.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00823576
First received: January 14, 2009
Last updated: May 31, 2011
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
 Drug: Ropivacaine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Ropivacaine Continuous Wound Instillation Versus Single Shot After Spine Fusion Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Primary end points Principal: We compare the pain between 2 groups by means of the EVA (score of 0 for absence of pain in 10 for conceivable maximal pain) measured at H2, H8, H16, H24, H48. [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The consumption of morphine mg-The rate of the nausea and the postoperative vomits defined-Delay up to the first rise-Delay will be estimated in hours enter the end of the intervention surgery and the first one night [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: December 2008
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1

Group witness: one receiving a single bolus of analgesic

Seepage simple person the end of intervention of 200mg of ropivacaïne 0,5 % at the level of zones it

 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.
Active Comparator: 2
Group catheter: receiving a single bolus of analgesic and an infiltration of Ropivacaine during 48 hours.
 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823576

Locations
France
CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez
Nice, Alpes-Maritimes, France, 06001
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: LITRICO LS Stéphane, PH CHU de Nice - Hôpital Pasteur - 30 ave de la Voie Romaine - 06100 Nice
  More Information

No publications provided

Responsible Party: CAILLON Cynthia, CHU de Nice
ClinicalTrials.gov Identifier: NCT00823576     History of Changes
Other Study ID Numbers: 08-CIR-03
Study First Received: January 14, 2009
Last Updated: May 31, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Nice:
Arthodeses rachis lombar
Spinal Surgery

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Analgesics
Ropivacaine
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 19, 2013