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

NCT06559137 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STU-2024-0774
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Narcotic use; Postoperative pain management; ACL reconstruction; Visual Analog Scale (VAS) pain scores; Multimodal pain management protocol

Outcome Measures

Primary Outcomes (4)

• Visual Analog Scale (VAS) Wong-Baker Face Pain Scale

  Scale with evocative faces from 0-10 (0 = No Pain, 10 = Worst Pain Possible) that assists children in communicating about their pain

  Postoperative days 1, 4, and 7

• Visual Analog Scale (VAS) 10-centimeter line 0-10 Numeric Pain Intensity Scale

  Sliding scale from 0-10 (0 = No Pain, 10 = Pain as bad as it could possibly be) that enables a more accurate estimate of pain score

  Postoperative days 1, 4, and 7

• Scottish Rite for Children-developed pain questionnaire

  Institutional questionnaire that asks how many narcotic pills the patient has taken (0 - 12 pills), if their pain is controlled, treatments that lessens their pain, term that best describes their pain, how much their pain has interfered with daily tasks and overall mood, and sleep interference due to pain.

  Postoperative days 1, 4, and 7

• Pain Management Patient Satisfaction questionnaire

  Questionnaire that asks how satisfied patients are with their pain treatment (0 = Not Satisfied, 10 = Extremely Satisfied), if they contacted their physician due to ineffective pain treatment, how helpful the information provided for pain treatment was (0 = Not Helpful, 10 = Extremely Helpful), and a free response section to explain why they were not satisfied with their pain treatment and if they have any additional comments or suggestions based on their pain treatment.

  Postoperative day 7

Secondary Outcomes (1)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Scale v1.0 - Global Health 7+2

  Preoperatively and within one week postoperatively.

Study Arms (2)

Peripheral Nerve Block (PNB) group

ACTIVE COMPARATOR

* 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

Drug: Ropivacaine 0.2% Injectable Solution

No Peripheral Nerve Block (PNB) group

NO INTERVENTION

\- 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

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.

Also known as: Naropin

Peripheral Nerve Block (PNB) group

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Must be aged 13+ years at time of surgery
• Must present with injury requiring an ACLR procedure with a Bone Patellar Tendon Bone or Quadriceps graft
• Ability to provide assent, legally appointed representative available to provide informed consent

You may not qualify if:

• Patient \<13 years old
• Requires fracture repair or another non-standardized surgery
• Any ACLR that requires the use of a graft type other than Bone Patellar Tendon Bone or Quadriceps tendon
• Any lower extremity procedure that is not primarily an ACLR
• Patient pregnancy
• Inability to provide assent or legally appointed representative to provide informed consent
• Prior history of hypersensitivity to Ropivacaine or any local anesthesia
• BMI ≥ 40

Sponsors & Collaborators

• Texas Scottish Rite Hospital for Children: lead

Study Sites (1)

Texas Scottish Rite Hospital for Children

Frisco, Texas, 75034, United States

Location

MeSH Terms

Conditions

Lacerations; Agnosia; Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Philip Wilson, MD

  Texas Scottish Rite Hospital for Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Van Pelt, MPH

CONTACT

2145597456; bobby.vanpelt@tsrh.org

Anna Wilhelmy, MS

CONTACT

469-857-2109; anna.wilhelmy@tsrh.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be randomized after consent is obtained and will not know if they receive a single-shot peripheral nerve block. Due to current standard of care procedures, all patients will consent to receiving a peripheral nerve block despite their randomized group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

US (1)