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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Pain, Postoperative, Surgery, Thoracic

Intervention / Treatment
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* Drug: Ropivacaine/Fentanyl
* Drug: Bupivacaine/Fentanyl


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine/Fentanyl<br> | Drug: Ropivacaine/Fentanyl<br>* Ropivacaine 0.2% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr<br>* Other names: ROPIVACAINE HYDROCHLORIDE 10 mg/ml;|
| Active Comparator: Bupivacaine/Fentanyl<br> | Drug: Bupivacaine/Fentanyl<br>* Bupivacaine 0.125% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr<br>* Other names: BUPIVACAINE HYDROCHLORIDE 0.5%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity scores at rest (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.) |  | postoperative day: 0-3 | 
| Pain intensity scores during deep breathing (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.) |  | postoperative day: 0-3 | 
| Pain intensity scores during coughing (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.) |  | postoperative day: 0-3 | 
| Side Effect Occurrence |  | first 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fentanyl consumption [µg] |  | postoperative day: 0-3 | 
| The number of doses of metamizol as a rescue drug |  | postoperative day: 0-3 | 
| The number of nursing interventions undertaken to relive pain > 2/10 pts |  | postoperative day: 0-3 | 
| Patient satisfaction | Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good. | postoperative day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multimodal analgesia, Thoracic epidural, Postoperative pain, Postoperative Complications, Patient Satisfaction