drugset / Trial / NCT01698203

Continuous Wound Catheter Analgesia Associated With Intravenous Morphine PCA After Thoracotomy

NCT01698203 ↗

Phase 4 Completed 92 enrolled University Hospital, Strasbourg, France
RandomizedParallel-groupDouble-blindSupportive care

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.

Timeline

Start
2012-10-14
Primary completion
2012-10-14
Completion
2018-10-11

Outcome

Missed primary endpoint

paper There were no significant differences between the groups receiving ropivacaine and saline in terms of pain severity at rest and on coughing. PMID 21377888 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ropivacaine Other / unclassified 0.2 % Other

Indications

No indication recorded.