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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:
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:
This is a single institution, prospective, single-blinded (patient) randomized controlled trial to investigate the safety and pain-control efficacy and patient reported pain outcomes of PNBs in youth receiving ACLR. To be included, participants must be aged 13+ years at the time of surgery and present with an injury requiring an isolated ACL reconstruction with either a Bone-Patellar Tendon-Bone or Quadriceps tendon graft. Data will be collected from the patient's electronic medical record and from Oberd. Data collected will include age, height, weight, surgical information, diagnosis, and patient demographics. 160 participants (80 per treatment group) will be enrolled in the study with a minimum of 130 needed to complete the study.
As ACLR procedures are a frequent and standardized procedure at this institution, choosing to exclusively study this population offers a homogenous and plentiful sample. Pain protocols will follow a standard outline used by all participating surgeons to reduce variability between patients. The randomization technique of this study is supported by the equipoise of this institution's physicians regarding peripheral nerve blocks and the quantity of patients who this study's results will affect.
Patients will be approached pre-operatively for participation, after which the surgical team will be informed. Patients will be offered the choice to participate in the study and randomize their treatment group. If patients do not want their treatment to be randomized, they will not be included in the study. Data collection will involve the Wong-Baker Visual Analog Scale (VAS) and VAS 10-centimeter line 0-10 Numeric Pain Intensity Scale, and an institution specific pain questionnaire regarding analgesic medicine intake and complications daily from post-operative day one to post-operative day seven. Patients' medical records will also be reviewed for readmission, calls to their physician for pain, and other noted complications.
Patients will receive the following anesthesia doses by body weight (BW):
Pre-operatively:
0.1 mg Valium per kg BW (maximum 10 mg)
Intra-operatively:
Regardless of weight: 10 mL Exparel and 20 mL 0.25% Marcaine - Optional: 10-20 mcg Dexmedetomidine per kg BW (for persistent tachycardia) <50% Nitrous If intubated/ventilated: 0.5-0.6 mg Rocuronium per kg BW, ~2 mg/kg Suggamadex for reversal If Tranexamic Acid administered: 15 mg per kg BW (10-15 min intravenous, maximum 1 g) For maintenance: 1 Minimum Alveolar Concentration (MAC) Sevoflurane and 15 mg Acetaminophen per kg BW (maximum 1 g) If necessary during emergence: 0.004-0.005 mg Hydropmorphone per kg BW, 0.5 mg Ketorolac per kg BW (maximum 30 mg), and 0.1 mg Ondansetron per kg BW (maximum 4 mg) If PACU medication required: 0.004-0.006 mg Hydromorphone per kg BW and 0.10- 0.15 mg Oxycodone per kg BW, and Metoclopramide, Dexamethasone, Promethazine, or Ondansetron
Peripheral Nerve Block Group Only:
Placebo Group Only:
- 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 Modification / Update, MOD002-STU-2024-0774, Philip Wilson, 7/31/2025 STU-2024-0774, Wilson, FormA-Protocol, Mod_2, 07-31-25
Post-Operatively:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripheral Nerve Block (PNB) group | Active Comparator |
|
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Scale v1.0 - Global Health 7+2 | Questionnaire of outcomes regarding their overall health (scored 20-80, 20 = poor and 80 = good). | Preoperatively and within one week postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Van Pelt, MPH | Contact | 2145597456 | bobby.vanpelt@tsrh.org | |
| Anna Wilhelmy, MS | Contact | 469-857-2109 | anna.wilhelmy@tsrh.org |
| Name | Affiliation | Role |
|---|---|---|
| Philip Wilson, MD | Texas Scottish Rite Hospital for Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Scottish Rite Hospital for Children | Frisco | Texas | 75034 | United States |
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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.
|
| ID | Term |
|---|---|
| D022125 | Lacerations |
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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