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

Part of paid clinical trials in Frisco, Texas.

Sponsor
Texas Scottish Rite Hospital for Children
Study ID
NCT06559137
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
13 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Ropivacaine 0.2% Injectable Solution — DRUG
    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.

Study Details

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

Key Dates

Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Peripheral Nerve Block (PNB) group
    * A 20 mL Adductor PNB will be injected where determined as best place by anesthesiologist * Patient will receive 0.2% plain Ropivacaine (perineural injection) regardless of weight * Patient will be given a purple surgical marker dot at/near the site of injection by the anesthesiologist
  • No Intervention: No Peripheral Nerve Block (PNB) group
    \- Patients will be given a purple surgical marker dot at/near the site where a PNB would be administered by the anesthesiologist, if they were randomized to the placebo group

Primary Outcome Measure

Visual Analog Scale (VAS) Wong-Baker Face Pain Scale [ Time Frame: Postoperative days 1, 4, and 7 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Scottish Rite Hospital for ChildrenFriscoTexas75034
Robert Van Pelt, MPH
[email protected]
214-559-7456
Anna Wilhelmy, MS
[email protected]
469-857-2109
Philip Wilson, MD (PRINCIPAL_INVESTIGATOR)
Henry Ellis, MD (SUB_INVESTIGATOR)
John Arvesen, MD (SUB_INVESTIGATOR)
Cody Todesco, PA (SUB_INVESTIGATOR)
Benjamin Johnson, PA (SUB_INVESTIGATOR)
Charles Wyatt, CPNP (SUB_INVESTIGATOR)
Stephanie Stutz, MS (SUB_INVESTIGATOR)

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Texas Scottish Rite Hospital for Children· Frisco, TX

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