Ropivacaine for Pain

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Pain+2 MoreRopivacaine - Drug
Eligibility
4 - 12
All Sexes
What conditions do you have?
Select

Study Summary

This trial is investigating whether preoperative regional anesthesia can reduce postoperative pain and the need for opioids in children with a certain type of broken bone.

Eligible Conditions
  • Pain
  • Closed Fractures
  • Broken Arm

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Immediately after surgery. Until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days.

Week 1
Total Quality Pain Management (TQPM) Instrument: 30 question questionnaire
Week 1
Change in Wong-Baker FACES Pain Scale-Revised (FPSR)
Day 10
Pain Medication Logs (Amount Taken)
Pain Medication Logs (Side Effects)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Infraclavicular Regional Block
1 of 2
Puncture Wound
1 of 2

Experimental Treatment

Non-Treatment Group

90 Total Participants · 2 Treatment Groups

Primary Treatment: Ropivacaine · Has Placebo Group · Phase 4

Infraclavicular Regional Block
Drug
Experimental Group · 1 Intervention: Ropivacaine · Intervention Types: Drug
Puncture Wound
Other
ShamComparator Group · 1 Intervention: Puncture Wound and Dressing · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: immediately after surgery. until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days.

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,411 Previous Clinical Trials
6,941,475 Total Patients Enrolled
8 Trials studying Pain
1,209 Patients Enrolled for Pain

Eligibility Criteria

Age 4 - 12 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
had a significantly lower nonunion rate than those treated with closed reduction percutaneous pinning
The patient suffered an isolated lateral condyle humerus fracture.
present with an increased incidence of articular surface displacement and a poor prognosis
A fracture of the lateral condyle of the humerus.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Orthopaedic Institute for Children100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%