NCT03444636

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

2 years

First QC Date

February 16, 2018

Last Update Submit

May 26, 2020

Conditions

Pain, PostoperativeSurgery, Thoracic

Keywords

Multimodal analgesiaThoracic epiduralPostoperative painPostoperative ComplicationsPatient Satisfaction

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • 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

    postoperative day 3

Study Arms (2)

Ropivacaine/Fentanyl

EXPERIMENTAL
Drug: Ropivacaine/Fentanyl

Bupivacaine/Fentanyl

ACTIVE COMPARATOR
Drug: Bupivacaine/Fentanyl

Interventions

Ropivacaine/FentanylDRUG

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

Also known as: ROPIVACAINE HYDROCHLORIDE 10 mg/ml
Ropivacaine/Fentanyl
Bupivacaine/FentanylDRUG

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

Also known as: BUPIVACAINE HYDROCHLORIDE 0.5%
Bupivacaine/Fentanyl

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Tuberculosis and Lung Diseases, Pediatric Division

Rabka-Zdrój, Małopolska, 34-700, Poland

Location

Related Publications (7)

  • 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.

    PMID: 25293474BACKGROUND

  • 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.

    PMID: 26827847BACKGROUND

  • 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.

    PMID: 25599577BACKGROUND

  • 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.

    PMID: 21199114BACKGROUND

  • 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.

    PMID: 11359592BACKGROUND

  • 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.

    PMID: 31103498BACKGROUND

  • 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.

    PMID: 30451243BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativePostoperative ComplicationsPatient Satisfaction

Interventions

RopivacaineFentanylBupivacaine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Lucyna Tomaszek, PhD

    National Institute for Tuberculosis and Lung Diseases, Poland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Nursing, Specialist Nurse in Anesthesia and Intensive Care

Study Record Dates

First Submitted

February 16, 2018

First Posted

February 23, 2018

Study Start

March 2, 2015

Primary Completion

March 14, 2017

Study Completion

March 14, 2017

Last Updated

May 28, 2020

Record last verified: 2020-05

Locations

PL(1)