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NOT YET RECRUITING
NCT06559137
PHASE2

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

Sponsor: Texas Scottish Rite Hospital for Children

View on ClinicalTrials.gov

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

Official title: Prospective Evaluation of Post-operative Pain Management Using Peripheral Nerve Blocks in the Pediatric Population

Key Details

Gender

All

Age Range

13 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2025-09

Completion Date

2028-09

Last Updated

2025-09-16

Healthy Volunteers

No

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.

Locations (1)

Texas Scottish Rite Hospital for Children

Frisco, Texas, United States