Skip to main content
OpenTrials
Completed

NCT Number: NCT00620490

Paravertebral Analgesia Associated With Intravenous Morphine PCA After Thoracotomy

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Service de Chirurgie Thoracique, Hôpitaux Universitaires

Strasbourg, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

Ropivacaine 0.5% 0.1 ml/kg per hour

nacl 0,9%

Other

saline 0.9% 0.1 ml/kg per hour

Primary outcomes

  1. Pain after surgery

    Time frame: first 48 hours after surgery

Secondary outcomes

  1. · 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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 21, 2008
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.