NCT02924324

Brief Summary

The purpose of this study is to identify whether or not the addition of a numbing medicine that is injected directly into the site of the bone marrow procedure can reduce pain and the use of opioid pain medication after bone marrow procedures. The addition of this medicine, called ropivacaine, is the experimental part of this study. This is the first time ropivacaine will be directly injected into the bone marrow site at MSKCC Pediatrics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

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

October 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

April 26, 2022

Completed
Last Updated

November 8, 2022

Status Verified

October 1, 2021

Enrollment Period

3.1 years

First QC Date

October 3, 2016

Results QC Date

August 19, 2020

Last Update Submit

October 18, 2022

Conditions

Neuroblastoma

Keywords

local Injectionpain Medicationpropofolropivacaine16-1417

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm

    Number of participants requiring post-procedural opioid analgesia within 24 hours (+/- 4 hours) post procedure per study arm

    within 24 hours (+/- 4 hours) post procedure

Study Arms (2)

Propofol First, then Propofol & Ropivacaine

ACTIVE COMPARATOR

1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol \& ropivacaine

Device: propofolBehavioral: Wong-Baker FACES® Pain Rating ScaleBehavioral: Post-procedural quality of life (QOL)

Propofol and Ropivacaine First, then Propofol

EXPERIMENTAL

1st BM procedure: Intervention B: propofol \& ropivacaine first. Then second BM procedure with propofol

Drug: ropivacaineBehavioral: Wong-Baker FACES® Pain Rating ScaleBehavioral: Post-procedural quality of life (QOL)

Interventions

propofolDEVICE
Propofol First, then Propofol & Ropivacaine
ropivacaineDRUG
Propofol and Ropivacaine First, then Propofol
Wong-Baker FACES® Pain Rating ScaleBEHAVIORAL

Nurses will record patient-reported pain scores.

Propofol First, then Propofol & RopivacainePropofol and Ropivacaine First, then Propofol
Post-procedural quality of life (QOL)BEHAVIORAL
Propofol First, then Propofol & RopivacainePropofol and Ropivacaine First, then Propofol

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of neuroblastoma as defined by the International Neuroblastoma Risk Group Staging System (INRGSS)22
  • years of age
  • Patient has had prior bone marrow procedures
  • English speaking

You may not qualify if:

  • History of allergy to investigational agent: ropivacaine or other amino amide analgesics
  • History of allergy to standard agent: propofol
  • Chronic daily opioid requirement
  • Lansky/Karnofsky Score \< 60
  • Inability to comply with protocol requirements including refusal to forego pre-procedural opioid use
  • Patient is receiving additional potentially painful interventions (e.g. central line insertion/removal) concurrent with the bone marrow procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

  • Zarnegar-Lumley S, Lange KR, Mathias MD, Nakajima-Hatano M, Offer KM, Ogu UO, Ortiz MV, Tan KS, Kellick M, Modak S, Roberts SS, Basu EM, Dingeman RS. Local Anesthesia With General Anesthesia for Pediatric Bone Marrow Procedures. Pediatrics. 2019 Aug;144(2):e20183829. doi: 10.1542/peds.2018-3829.

    PMID: 31366683DERIVED

Related Links

MeSH Terms

Conditions

Neuroblastoma

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr. Ellen Basu, MD, PhD
Organization
Memorial Sloan Kettering Cancer Center
BasuE@mskcc.org
212-639-5204

Study Officials

  • Ellen Basu, MD, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 5, 2016

Study Start

October 1, 2016

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

November 8, 2022

Results First Posted

April 26, 2022

Record last verified: 2021-10

Locations

US(1)