Multimodal Analgesia in Children and Adolescents After the Ravitch Procedure and Thoracotomy

National Institute for Tuberculosis and Lung Diseases, Poland

Status and phase: Completed; Phase 4

Conditions: Surgery, Thoracic; Pain, Postoperative

Treatments: Drug: Bupivacaine/Fentanyl; Drug: Ropivacaine/Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03444636

10.7

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 94 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Ropivacaine/Fentanyl

Experimental group

Treatment:

Drug: Ropivacaine/Fentanyl

Bupivacaine/Fentanyl

Active Comparator group

Treatment:

Drug: Bupivacaine/Fentanyl