Continuous Wound Catheter Analgesia Associated With Intravenous Morphine PCA After Thoracotomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01698203
First received: September 28, 2012
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

Objective: Epidural analgesia is the gold standard for post-thoracotomy pain relief but is contraindicated in certain patients. An alternative is continuous wound catheter analgesia. We will investigate whether ropivacaine, administered through a wound catheter placed by the surgeon, will reduce postoperative pain. Methods: In a randomized double-blind study, adult patients with a wound catheter placed by the thoracic surgeon after thoracotomy will be randomly assigned to receive through this catheter, either a 0.1 mL/kg bolus of 0.75% ropivacaine, followed by a continuous infusion of 0.2% ropivacaine at 10 mL/h for 48 h, or saline at the same scheme of administration. Patients will also benefit from patient-controlled analgesia with intravenous morphine (bolus 1 mg, lockout time 7 min), paracetamol, and nefopam. The primary endpoint will be total morphine consumption. Secondary endpoints will be pain intensity on a visual analog scale at rest and on coughing and side effects during the first 48 postoperative hours. Surgeons, anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of saline and ropivacaine will be prepared identically by the central pharmacy, without any possible identification of the product.


Condition Intervention Phase
Pain
Thoracotomy
Drug: ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)
Drug: Placebo
Drug: ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Postoperative Analgesia After Thoracotomy Without Thoracic Epidural Analgesia: Continuous Wound Catheter Analgesia Associated With Intravenous Morphine Patient-Controlled-Analgesia (PCA)

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Total intravenous morphine consumption (mg) [ Time Frame: the first 48 hours after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 92
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ropivacaine Drug: ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)
The group ropivacaine, an initial bolus of 0.75% ropivacaine at a volume of 0.1 ml / kg is first administered to the patient directly on the catheter.
Drug: ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)
The patient will then ongoing administration of ropivacaine 0.2% during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled (B Braun) of this solution, a flow rate of 9.53 ml / hour
Placebo Comparator: placebo Drug: Placebo
In the placebo group, an initial bolus of saline 9 ‰ to a volume of 0.1 ml / kg will first be administered to the patient directly to the catheter. The patient will then continuous administration of saline 9 ‰ during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled of this solution, a flow rate of 9.53 ml / hour.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 auriculo-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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698203

Contacts
Contact: Olivier Helms, MD olivier.helms@chru-strasbourg.fr

Locations
France
Hôpital Civil - NHC Département d'Anesthésiologie Recruiting
STRASBOURG Cedex, Alsace, France, 67091
Principal Investigator: Olivier HELMS, MD         
Sub-Investigator: Annick STEIB, PHD         
Sub-Investigator: Jean gustave HENTZ, MD         
Sub-Investigator: Jean- Marie WIHLM, PHD         
Sub-Investigator: Gilbert MASSARD, PHD         
Sub-Investigator: Pierre- Emmanuel FALCOZ P, PHD         
Sub-Investigator: Nicola SANTELMO, MD         
Sub-Investigator: Anne OLLAND, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Olivier Helms, MD
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01698203     History of Changes
Other Study ID Numbers: 5277
Study First Received: September 28, 2012
Last Updated: May 12, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014