Paravertebral Analgesia Associated With Intravenous Morphine PCA After Thoracotomy

NCT ID: NCT00620490

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-03-31

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).

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Ropivacaine 0.5% 0.1 ml/kg per hour

Group Type: EXPERIMENTAL

ropivacaine

Intervention Type: DRUG

Ropivacaine 0.5% 0.1 ml/kg per hour

2

Group Type: PLACEBO_COMPARATOR

nacl 0,9%

Intervention Type: OTHER

saline 0.9% 0.1 ml/kg per hour

Interventions

ropivacaine

Ropivacaine 0.5% 0.1 ml/kg per hour

Intervention Type: DRUG

nacl 0,9%

saline 0.9% 0.1 ml/kg per hour

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier Helms, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

Service de Chirurgie Thoracique, Hôpitaux Universitaires

Strasbourg, , France

Countries

France

References

Helms O, Mariano J, Hentz JG, Santelmo N, Falcoz PE, Massard G, Steib A. Intra-operative paravertebral block for postoperative analgesia in thoracotomy patients: a randomized, double-blind, placebo-controlled study. Eur J Cardiothorac Surg. 2011 Oct;40(4):902-6. doi: 10.1016/j.ejcts.2011.01.067. Epub 2011 Mar 5.

Reference Type: RESULT

PMID: 21377888 (View on PubMed)

Other Identifiers

4068

Identifier Type: -

Identifier Source: org_study_id