A Phase 4 interventional study of Ropivacaine/Fentanyl and Bupivacaine/Fentanyl in Pain, Postoperative and Surgery, Thoracic, sponsored by National Institute for Tuberculosis and Lung Diseases, Poland. Completed at 1 site in Poland. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-05-28.
Sponsored by National Institute for Tuberculosis and Lung Diseases, Poland · Phase 4, Interventional, and Treatment
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).
Exclusion Criteria:
Drug: Ropivacaine/Fentanyl
Drug: Bupivacaine/Fentanyl
Ropivacaine 0.2% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr
Also known as: ROPIVACAINE HYDROCHLORIDE 10 mg/ml
Bupivacaine 0.125% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr
Also known as: BUPIVACAINE HYDROCHLORIDE 0.5%
Pain intensity scores at rest (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)
Time frame: postoperative day: 0-3
Pain intensity scores during deep breathing (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)
Time frame: postoperative day: 0-3
Pain intensity scores during coughing (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)
Time frame: postoperative day: 0-3
Side Effect Occurrence
Time frame: first 3 days after surgery
Total fentanyl consumption [µg]
Time frame: postoperative day: 0-3
The number of doses of metamizol as a "rescue drug"
Time frame: postoperative day: 0-3
The number of nursing interventions undertaken to relive pain > 2/10 pts
Time frame: postoperative day: 0-3
Patient satisfaction
Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good.
Time frame: postoperative day 3
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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National Institute for Tuberculosis and Lung Diseases, Poland