Continuous Wound Catheter Analgesia Associated With Intravenous Morphine PCA After Thoracotomy

Postoperative Analgesia After Thoracotomy Without Thoracic Epidural Analgesia: Continuous Wound Catheter Analgesia Associated With Intravenous Morphine Patient-Controlled-Analgesia (PCA)

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.

Study Overview

• Status: Completed
• Conditions: Pain; Thoracotomy
• Intervention / Treatment: Drug: ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun); Drug: ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Alsace
    • Strasbourg, Alsace, France, 67091
      • Hôpital Civil - NHC Département d'Anesthésiologie

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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total intravenous morphine consumption (mg)	the first 48 hours after surgery

Collaborators and Investigators

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

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 (Actual): October 14, 2012
• Primary Completion (Actual): October 14, 2012
• Study Completion (Actual): October 11, 2018

Study Registration Dates

• First Submitted: September 28, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (Estimated): October 2, 2012

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• 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: 5277