Continuous Wound Catheter Analgesia Associated With Intravenous Morphine PCA After Thoracotomy (NCT01698203) | Clinical Trial Compass
CompletedPhase 4
Continuous Wound Catheter Analgesia Associated With Intravenous Morphine PCA After Thoracotomy
France92 participantsStarted 2012-10-14
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.