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Pain, PostoperativePhase 4NCT03444636

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

A Phase 4 study testing Ropivacaine/Fentanyl and Bupivacaine/Fentanyl in people with Pain, Postoperative and Surgery, Thoracic, run by National Institute for Tuberculosis and Lung Diseases, Poland at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 5 to 18 years
Conditions the study is for
Pain, Postoperative, Surgery, Thoracic
What is being tested?
Ropivacaine/Fentanyl and Bupivacaine/Fentanyl
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 sitePoland
Study dates
2 Mar 2015to 14 Mar 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Poland1 site

  • Institute for Tuberculosis and Lung Diseases, Pediatric Division

    Rabka-Zdrój, Małopolska, 34-700

Other trials in Poland

About this study

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

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.

Read the detailed 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).

Being tested
Ropivacaine/Fentanyl, Bupivacaine/Fentanyl
Keywords
Multimodal analgesia, Thoracic epidural, Postoperative pain, Postoperative Complications, Patient Satisfaction
Medical subject headings
Pain, Postoperative, Postoperative Complications, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropivacaine/FentanylDrug

    Also called ROPIVACAINE HYDROCHLORIDE 10 mg/ml

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

  • Bupivacaine/FentanylDrug

    Also called BUPIVACAINE HYDROCHLORIDE 0.5%

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

Study groups in NCT03444636
Study groupRoleWhat they receive
Ropivacaine/FentanylExperimentalNot described
Receives: Drug: Ropivacaine/Fentanyl
Bupivacaine/FentanylActive comparatorNot described
Receives: Drug: Bupivacaine/Fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain intensity scores at rest (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)

    Measured: postoperative day: 0-3

  2. Pain intensity scores during deep breathing (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)

    Measured: postoperative day: 0-3

  3. Pain intensity scores during coughing (FLACC for patients <7 y.o., Numerical Rating Scale for patients >7 y.o.)

    Measured: postoperative day: 0-3

  4. Side Effect Occurrence

    Measured: first 3 days after surgery

Secondary outcomes (4)

  1. Total fentanyl consumption [µg]

    Measured: postoperative day: 0-3

  2. The number of doses of metamizol as a "rescue drug"

    Measured: postoperative day: 0-3

  3. The number of nursing interventions undertaken to relive pain > 2/10 pts

    Measured: postoperative day: 0-3

  4. Patient satisfaction

    Satisfaction was evaluated on a 4-item scale: analgesia was rated as insufficient, poor, good or very good.

    Measured: postoperative day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2018
  2. Study start2 Mar 2015
  3. Primary completion14 Mar 2017
  4. Study completion14 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03444636
Sponsor's protocol ID
10.7
Status last verified
May 2020
First submitted
16 Feb 2018
Last updated
28 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Misiolek H, Cettler M, Woron J, Wordliczek J, Dobrogowski J, Mayzner-Zawadzka E. The 2014 guidelines for post-operative pain management. Anaesthesiol Intensive Ther. 2014 Sep-Oct;46(4):221-44. doi: 10.5603/AIT.2014.0041. No abstract available.

    PubMed 25293474

  • Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

    PubMed 26827847

  • Schnabel A, Thyssen NM, Goeters C, Zheng H, Zahn PK, Van Aken H, Pogatzki-Zahn EM. Age- and procedure-specific differences of epidural analgesia in children--a database analysis. Pain Med. 2015 Mar;16(3):544-53. doi: 10.1111/pme.12633. Epub 2015 Jan 19.

    PubMed 25599577

  • Ecoffey C, Lacroix F, Giaufre E, Orliaguet G, Courreges P; Association des Anesthesistes Reanimateurs Pediatriques d'Expression Francaise (ADARPEF). Epidemiology and morbidity of regional anesthesia in children: a follow-up one-year prospective survey of the French-Language Society of Paediatric Anaesthesiologists (ADARPEF). Paediatr Anaesth. 2010 Dec;20(12):1061-9. doi: 10.1111/j.1460-9592.2010.03448.x.

    PubMed 21199114

  • Lejus C, Surbled M, Schwoerer D, Renaudin M, Guillaud C, Berard L, Pinaud M. Postoperative epidural analgesia with bupivacaine and fentanyl: hourly pain assessment in 348 paediatric cases. Paediatr Anaesth. 2001 May;11(3):327-32. doi: 10.1046/j.1460-9592.2001.00659.x.

    PubMed 11359592

  • Tomaszek L, Fenikowski D, Komotajtys H, Gawron D. Ropivacaine/Fentanyl vs. Bupivacaine/Fentanyl for Pain Control in Children after Thoracic Surgery: A Randomized Study. Pain Manag Nurs. 2019 Aug;20(4):390-397. doi: 10.1016/j.pmn.2019.02.007. Epub 2019 May 15.

    PubMed 31103498

  • Tomaszek L, Fenikowski D, Gawron D, Komotajtys H. Comparative efficacy of continuous infusion of bupivacaine/fentanyl and ropivacaine/fentanyl for paediatric pain control after the Ravitch procedure and thoracotomy. A prospective randomized study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2019 Dec;163(4):366-373. doi: 10.5507/bp.2018.072. Epub 2018 Nov 16.

    PubMed 30451243

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ropivacaine/Fentanyl and Bupivacaine/Fentanyl in people with Pain, Postoperative and Surgery, Thoracic, run by National Institute for Tuberculosis and Lung Diseases, Poland at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03444636, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.

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