Paravertebral Analgesia Associated With Intravenous Morphine PCA After Thoracotomy - Full Text View

Sponsored by:	University Hospital, Strasbourg, France
Information provided by:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT00620490

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 III

MedlinePlus related topics: Itching Nausea and Vomiting

Drug Information available for: Ropivacaine Ropivacaine Hydrochloride Ropivacaine monohydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Postoperative Analgesia After Thoracotomy Without Thoracic Epidural Analgesia : Paravertebral Analgesia With a Catheter Associated With Intravenous Morphine Patient-Controlled-Analgesia (Pca)

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 ]

Estimated Enrollment:	60
Study Start Date:	March 2008
Estimated Study Completion Date:	February 2009
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Ropivacaine 0.5% 0.1 ml/kg per hour	Drug: ropivacaine Ropivacaine 0.5% 0.1 ml/kg per hour
2: Placebo Comparator	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

Contacts

Contact: Olivier Helms, MD

00333.88.11.61.35

olivier.helms@chru-strasbourg.fr

Locations

France
Service de Chirurgie Thoracique, Hôpitaux Universitaires	Recruiting
Strasbourg, France
Contact: Olivier Helms, MD 00333.88.11.67.60 Olivier.Helms@chru-strasbourg.fr
Principal Investigator: Olivier Helms, MD
Sub-Investigator: Jean-Gustave Hentz, MD
Sub-Investigator: Jean-Marie Wilhm, MD
Sub-Investigator: Gilbert Massard, MD
Sub-Investigator: Nicola Santelmo, MD
Sub-Investigator: Mircea Vasilescu, MD

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

Principal Investigator:

Olivier Helms, MD

Hôpitaux Universitaires de Strasbourg

More Information

Responsible Party:	Hôpitaux Universitaires de Strasbourg ( Emmanuel Lavoué, Directeur adjoint de la recherche clinique et de l'innovation )
Study ID Numbers:	4068
Study First Received:	February 7, 2008
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00620490
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Strasbourg, France:

Epidural analgesia
Contraindications
Paravertebral nerve block analgesia
ropivacaine

Visual analogical scale
Morphine
Side effects
Pain and thoracotomy

Study placed in the following topic categories:

Morphine
Ropivacaine
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anesthetics, Local
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009