Clinical trial NCT01698203: Continuous Wound Catheter Analgesia Associated With Intravenous Morphine PCA After Thoracotomy
Official title: Postoperative Analgesia After Thoracotomy Without Thoracic Epidural Analgesia: Continuous Wound Catheter Analgesia Associated With Intravenous Morphine Patient-Controlled-Analgesia (PCA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Thoracotomy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility 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

Primary outcomes:
measure: Total intravenous morphine consumption (mg)
timeFrame: the first 48 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: STRASBOURG Cedex
country: France
facility: Hôpital Civil - NHC Département d'Anesthésiologie
state: Alsace
Study officials:
name: Olivier Helms, MD
role: PRINCIPAL_INVESTIGATOR
References: