Paravertebral Analgesia Associated With Intravenous Morphine PCA After Thoracotomy

Pain Clinical Trial

Official title:

Postoperative Analgesia After Thoracotomy Without Thoracic Epidural Analgesia : Paravertebral Analgesia With a Catheter Associated With Intravenous Morphine Patient-controlled-analgesia (Pca)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620490
• Other study ID #: 4068
• Status: Completed
• Phase: Phase 3
• First received: February 7, 2008
• Last updated: June 25, 2010
• Start date: March 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2008
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• ropivacaine
Ropivacaine 0.5% 0.1 ml/kg per hour

Other:
• nacl 0,9%
saline 0.9% 0.1 ml/kg per hour

Locations

Country	Name	City	State
France	Service de Chirurgie Thoracique, Hôpitaux Universitaires	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain		first 48 hours after surgery	Yes
Secondary	· Total dosis of morphine consumption, side effects nausea, vomiting,pruritus,Urinary retention, respiratory rate and sedation, · heart rate, blood pressure and peripheral saturation		first 48 hours after surgery	Yes