Paravertebral Analgesia Associated With Intravenous Morphine PCA After Thoracotomy

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

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).

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: ropivacaine; Other: nacl 0,9%

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Strasbourg, France
    • Service de Chirurgie Thoracique, Hôpitaux Universitaires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2	Other: nacl 0,9%; saline 0.9% 0.1 ml/kg per hour
Experimental: 1; Ropivacaine 0.5% 0.1 ml/kg per hour	Drug: ropivacaine; Ropivacaine 0.5% 0.1 ml/kg per hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain after surgery	first 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
· 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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Olivier Helms, MD, Hôpitaux Universitaires de Strasbourg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: February 7, 2008
• First Submitted That Met QC Criteria: February 20, 2008
• First Posted (Estimated): February 21, 2008

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Epidural analgesia; Morphine; ropivacaine; Side effects; Contraindications; Paravertebral nerve block analgesia; Visual analogical scale; Pain and thoracotomy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Ropivacaine
• Other Study ID Numbers: 4068