Trial | NCT03444636  Report issue

Title

Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy
The Efficacy and Safety of Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy - a Prospective Randomized Study

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    94
The study was performed in patients aged 6-18 years after the Ravitch procedure and thoracotomy. The primary aim of the study was to evaluate the efficacy and safety of pain control provided by the multimodal approach that involves the continuous infusion ropivacaine with fentanyl vs. bupivacaine with fentanyl through thoracic epidural catheter. Secondary aims were to identify the determinants of acute post-operative pain at rest, during deep breathing and coughing.
The subjects were randomized to the Ropivacaine/Fentanyl (RF) or Bupivacaine/Fentanyl (BF) group.

To perform a thoracic surgical procedure, all patients were premedicated with midazolam, and then, paracetamol, non-steroidal anti-inflammatory drugs, fentanyl, propofol, pancuronium or rocuronium (in children < 10 years old) and suprane were used to introduce and maintain the anesthesia. Thoracic epidural catheters were placed following induction of anesthesia and endotracheal intubation.

Intraoperative analgesia was introduced by a single dose of lidocaine 2% (2 mg/kg). Then after 15 minutes, the patients from the RF group received ropivacaine 1% (1-3 mg/kg) and those from the BF group bupivacaine 0.5% (0.5-1 mg/kg). After 60 minutes 0.2% ropivacaine solution with fentanyl or 0.125% solution of bupivacaine with fentanyl was infused with the flow rate of 0.1 ml/kg/hr.

Depending on the allocation to the group, postoperative analgesia was continued either with 0.2% ropivacaine and fentanyl or 0.125% bupivacaine and fentanyl, based on the concentration and the flow rate described above. In addition, intravenous paracetamol was administered as standard every 6 hours (the maximum of 60 mg/kg daily) along with non steroidal anti-inflammatory drugs. In children > 14 years of age, ketoprofen was injected at the dose of 1 mg/kg (the maximum of 200 mg daily) and in younger children ibuprofen (orally or rectally, up to 30 mg/kg daily) every 8 hours. Metamizol was given as a "rescue drug" (20 mg/kg).
Study Started
Mar 02
2015
Primary Completion
Mar 14
2017
Study Completion
Mar 14
2017
Last Update
May 28
2020

Drug Ropivacaine/Fentanyl [fentanyl (Innovar), ropivacaine (naropin)]

Ropivacaine 0.2% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr

  • Other names: ROPIVACAINE HYDROCHLORIDE 10 mg/ml

Drug Bupivacaine/Fentanyl [bupivacaine (Exparel), fentanyl (Innovar)]

Bupivacaine 0.125% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr

  • Other names: BUPIVACAINE HYDROCHLORIDE 0.5%

Ropivacaine/Fentanyl Experimental

Bupivacaine/Fentanyl Active Comparator

Criteria 

Inclusion Criteria:

Elective thoracic surgery (thoracotomy or Ravitch procedure);
Analgesia: continuous thoracic epidural analgesia.

Exclusion Criteria:

American Society of Anesthesiologists physical status >III;
History of chronic pain or preoperative opioid use;
Oncological treatment;
Impaired verbal communication;
Removal of epidural catheter <24 h postoperatively;
Lack of postoperative chest drainage.
No Results Posted