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Paravertebral Analgesia Associated With Intravenous Morphine PCA After Thoracotomy

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00620490
First received: February 7, 2008
Last updated: June 25, 2010
Last verified: March 2008
History of Changes
  Purpose

osteolateral thoracotomy is a painful surgical procedure.Thoracic epidural analgesia (TEA) is usually considered as the "gold standard" for postoperative thoracic analgesia. Unfortunately, it's not always possible to realize it because of contraindications or because of technical failures.Analgesia using a paravertebral block is an alternative to the TEA : it provides an unilateral sensitive and sympathetic block using a catheter.In our study, the catheter will be placed by the thoracic surgeon at the end of the surgical procedure, under direct vision, to insure maximal security also on patients on antiplatelets agents, anticoagulants or with haemostasis disorders (the placement of the catheter by the anaesthetist with the loss of resistance technique is contraindicated in these cases).Patients will be randomized to receive either a continuous 48-hours infusion of ropivacaine 0,5% or saline serum in the control group.All patients are connected to a PCA pump with intravenous morphine and will receive paracetamol and nefopam.The visual analogic scale (VAS) at rest and on movement, total morphine consumption and side effects will be recorded during the first 48 hours after surgery. The aim of this study is to prove a decrease of pain at rest and on movement, a decrease of the cumulated total morphine dose consumption and a decrease of the side effects (nausea, vomiting, pruritus, sedation, bradypnea, urinary retention).


Condition Intervention Phase
Pain
 Drug: ropivacaine
Other: nacl 0,9%
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Postoperative Analgesia After Thoracotomy Without Thoracic Epidural Analgesia : Paravertebral Analgesia With a Catheter Associated With Intravenous Morphine Patient-controlled-analgesia (Pca)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Pain [ Time Frame: first 48 hours after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • · Total dosis of morphine consumption, side effects nausea, vomiting,pruritus,Urinary retention, respiratory rate and sedation, · heart rate, blood pressure and peripheral saturation [ Time Frame: first 48 hours after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: March 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ropivacaine 0.5% 0.1 ml/kg per hour
 Drug: ropivacaine
Ropivacaine 0.5% 0.1 ml/kg per hour
Placebo Comparator: 2 Other: nacl 0,9%
saline 0.9% 0.1 ml/kg per hour

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for thoracotomy who presented with contraindications to TEA.Contraindications to TEA are :
  • Patient's refusal after informations about advantages and risks of the technique
  • Anti platelets treatment that can't be discontinued
  • Anticoagulants at a curative dosage- haemostasis and/or coagulation disorders: thrombopenia < 100.000/mm3, ACT > 1,5 / control, PTT < 75%- Systemic or local infection of the puncture point
  • 2 and 3 grade atrio-ventricular heart block without pacing
  • Severe aortic valve stenosis
  • Kyphoscoliosis
  • certain neurological disorders

Exclusion Criteria:

  • Patient's refusal to participate in the study
  • Psychiatric disorder (impossibility to collect the informed consent)
  • Patient under juridical protection
  • On going an other study
  • Pregnancy, breastfeeding
  • Non balanced epilepsy
  • 3 grade auriculae-ventricular heart block without pacing
  • Severe hepatocellular insufficiency
  • Anti arrhythmic treatment : class III of the Vaughan William's classification- Skin infection of the puncture point
  • Allergy to aminoamides local anaesthetic
  • Surgical difficulties to insert paravertebral catheter
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620490

Locations
France
Service de Chirurgie Thoracique, Hôpitaux Universitaires
Strasbourg, France
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Olivier Helms, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: Emmanuel Lavoué, Directeur adjoint de la recherche clinique et de l'innovation, Hôpitaux Universitaires de Strasbourg
ClinicalTrials.gov Identifier: NCT00620490     History of Changes
Other Study ID Numbers: 4068
Study First Received: February 7, 2008
Last Updated: June 25, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Strasbourg, France:
Epidural analgesia
Contraindications
Paravertebral nerve block analgesia
ropivacaine
 Visual analogical scale
Morphine
Side effects
Pain and thoracotomy

Additional relevant MeSH terms:
Morphine
Ropivacaine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Anesthetics, Local
Anesthetics

ClinicalTrials.gov processed this record on May 23, 2013