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

Not Applicable

Completed

• Conditions: Neuroblastoma
• Interventions: Drug: ropivacaine; Device: propofol; Behavioral: Wong-Baker FACES® Pain Rating Scale; Behavioral: Post-procedural quality of life (QOL)

• Registration Number: NCT02924324
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-05
• Primary Completion: 2019-11
• Study Completion: 2019-11
• Results First Submitted: 2020-08-19
• Status Verified: 2021-10
• Results First Submitted QC: 2022-03-30
• Results First Posted: 2022-04-26
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Propofol and Ropivacaine First, then Propofol	ropivacaine	1st BM procedure: Intervention B: propofol \& ropivacaine first. Then second BM procedure with propofol
Propofol First, then Propofol & Ropivacaine	Post-procedural quality of life (QOL)	1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol \& ropivacaine
Propofol First, then Propofol & Ropivacaine	propofol	1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol \& ropivacaine
Propofol and Ropivacaine First, then Propofol	Wong-Baker FACES® Pain Rating Scale	1st BM procedure: Intervention B: propofol \& ropivacaine first. Then second BM procedure with propofol
Propofol First, then Propofol & Ropivacaine	Wong-Baker FACES® Pain Rating Scale	1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol \& ropivacaine
Propofol and Ropivacaine First, then Propofol	Post-procedural quality of life (QOL)	1st BM procedure: Intervention B: propofol \& ropivacaine first. Then second BM procedure with propofol

Primary Outcome Measures

Name	Time	Method
Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm	within 24 hours (+/- 4 hours) post procedure	Number of participants requiring post-procedural opioid analgesia within 24 hours (+/- 4 hours) post procedure per study arm

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States