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Local Injection of Pain Medication to Reduce Pain After Bone Marrow Procedures in Pediatric Neuroblastoma Patients

Primary Purpose

Neuroblastoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
propofol
ropivacaine
Wong-Baker FACES® Pain Rating Scale
Post-procedural quality of life (QOL)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring local Injection, pain Medication, propofol, ropivacaine, 16-1417

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of neuroblastoma as defined by the International Neuroblastoma Risk Group Staging System (INRGSS)22
  • 3 - 18 years of age
  • Patient has had prior bone marrow procedures
  • English speaking

Exclusion Criteria:

  • 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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Propofol First, then Propofol & Ropivacaine

Propofol and Ropivacaine First, then Propofol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 3, 2016
Last Updated
October 18, 2022
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02924324
Brief Title
Local Injection of Pain Medication to Reduce Pain After Bone Marrow Procedures in Pediatric Neuroblastoma Patients
Official Title
RePPAIR -Reducing Procedural Pain and Improving Recovery of Quality of Life in Pediatric Neuroblastoma Patients Undergoing Bone Marrow Procedures: A Prospective Randomized Cross-over Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma
Keywords
local Injection, pain Medication, propofol, ropivacaine, 16-1417

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol First, then Propofol & Ropivacaine
Arm Type
Active Comparator
Arm Description
1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol & ropivacaine
Arm Title
Propofol and Ropivacaine First, then Propofol
Arm Type
Experimental
Arm Description
1st BM procedure: Intervention B: propofol & ropivacaine first. Then second BM procedure with propofol
Intervention Type
Device
Intervention Name(s)
propofol
Intervention Type
Drug
Intervention Name(s)
ropivacaine
Intervention Type
Behavioral
Intervention Name(s)
Wong-Baker FACES® Pain Rating Scale
Intervention Description
Nurses will record patient-reported pain scores.
Intervention Type
Behavioral
Intervention Name(s)
Post-procedural quality of life (QOL)
Primary Outcome Measure Information:
Title
Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm
Description
Number of participants requiring post-procedural opioid analgesia within 24 hours (+/- 4 hours) post procedure per study arm
Time Frame
within 24 hours (+/- 4 hours) post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of neuroblastoma as defined by the International Neuroblastoma Risk Group Staging System (INRGSS)22 3 - 18 years of age Patient has had prior bone marrow procedures English speaking Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Basu, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31366683
Citation
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.
Results Reference
derived
Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

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Local Injection of Pain Medication to Reduce Pain After Bone Marrow Procedures in Pediatric Neuroblastoma Patients

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