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Evaluation of Pain Management After Surgery When Using Nerve Blocks in the Pediatric Population

NCT06559137 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-09-16

No results posted yet for this study

Summary

The goal of this randomized clinical trial is to determine if single-shot ropivacaine peripheral nerve blocks (PNB - perineural injections) for anterior cruciate ligament (ACL) reconstruction procedures in pediatric orthopaedic sports medicine patients provides significant pain relief and decreased narcotic use. The main questions it aims to answer are:

* Does ropivacaine significantly reduce Visual Analog Scale (VAS) pain scores and pain levels up to one week postoperatively?
* Does ropivacaine significantly decrease narcotic use (number of pills taken) up to one week postoperatively?

Researchers will compare the pain outcomes and narcotic use of participants who receive a single-shot ropivacaine peripheral nerve block to those of participants who do not receive a single-shot ropivacaine peripheral nerve block for their ACL reconstruction surgery. The goal is to understand if there is a significant difference in participant pain outcomes and narcotic use outside the first 24 hours postoperatively.

Participants will:

* receive either a single-shot ropivacaine peripheral nerve block intraoperatively or no peripheral nerve block during their ACL Quadriceps tendon graft or bone patellar tendon bone graft reconstruction surgery.
* receive and complete questionnaires at postoperative days 1, 4, and 7 regarding their pain scores, levels, and outcomes, effective pain treatments, overall pain interference, narcotic use (number of pills taken), and overall pain treatment satisfaction
* receive and complete secondary outcome measures of functional and psychological outcomes regarding their ACL reconstruction surgery at postoperative day 1

Conditions

  • Anterior Cruciate Ligament (ACL) Tear
  • Sports Injuries in Children
  • Analgesia
  • Pain, Postoperative

Interventions

DRUG

Ropivacaine 0.2% Injectable Solution

Patients who are randomized to the peripheral nerve block group will receive a pre-operative perineural injection of 0.2% plain Ropivacaine regardless of weight.

Sponsors & Collaborators

  • Texas Scottish Rite Hospital for Children

    lead OTHER

Principal Investigators

  • Philip Wilson, MD · Texas Scottish Rite Hospital for Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-09-30
Completion
2028-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06559137 on ClinicalTrials.gov