Paravertebral Analgesia Associated With Intravenous Morphine PCA After Thoracotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00620490
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : June 28, 2010
Information provided by:
University Hospital, Strasbourg, France

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Drug: ropivacaine Other: nacl 0,9% Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : March 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Pain [ Time Frame: first 48 hours after surgery ]

Secondary Outcome Measures :
  1. · 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 ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00620490

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

Responsible Party: Emmanuel Lavoué, Directeur adjoint de la recherche clinique et de l'innovation, Hôpitaux Universitaires de Strasbourg Identifier: NCT00620490     History of Changes
Other Study ID Numbers: 4068
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: June 28, 2010
Last Verified: March 2008

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

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local