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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-02

Study Completion Date

2017-03-14

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.

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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).

Conditions

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Pain, Postoperative Surgery, Thoracic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ropivacaine/Fentanyl

Group Type EXPERIMENTAL

Ropivacaine/Fentanyl

Intervention Type DRUG

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

Bupivacaine/Fentanyl

Group Type ACTIVE_COMPARATOR

Bupivacaine/Fentanyl

Intervention Type DRUG

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

Interventions

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Ropivacaine/Fentanyl

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

Intervention Type DRUG

Bupivacaine/Fentanyl

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

Intervention Type DRUG

Other Intervention Names

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ROPIVACAINE HYDROCHLORIDE 10 mg/ml BUPIVACAINE HYDROCHLORIDE 0.5%

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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No