Paravertebral Analgesia Associated With Intravenous Morphine PCA After Thoracotomy
Information source: University Hospital, Strasbourg, France
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: ropivacaine (Drug); nacl 0,9% (Other)
Phase: Phase 3
Status: Recruiting
Sponsored by: University Hospital, Strasbourg, France Official(s) and/or principal investigator(s):
Olivier Helms, MD, Principal Investigator, Affiliation: Hôpitaux Universitaires de Strasbourg
Overall contact:
Olivier Helms, MD, Phone: 00333.88.11.61.35, Email: olivier.helms@chru-strasbourg.fr
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).
Clinical Details
Official title: Postoperative Analgesia After Thoracotomy Without Thoracic Epidural Analgesia : Paravertebral Analgesia With a Catheter Associated With Intravenous Morphine Patient-Controlled-Analgesia (Pca)
Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Pain
Secondary outcome: · Total dosis of morphine consumption, side effects
nausea, vomiting,pruritus,Urinary retention, respiratory rate and sedation, · heart rate, blood pressure and peripheral saturation
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Olivier Helms, MD, Phone: 00333.88.11.61.35, Email: olivier.helms@chru-strasbourg.fr
Service de Chirurgie Thoracique, Hôpitaux Universitaires, Strasbourg, France; Recruiting
Olivier Helms, MD, Phone: 00333.88.11.67.60, Email: Olivier.Helms@chru-strasbourg.fr
Olivier Helms, MD, Principal 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, Sub-Investigator
Additional Information
Starting date: March 2008
Ending date: February 2009
Last updated: March 3, 2008
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