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

NCT ID: NCT06559137

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-09-30

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

Detailed Description

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:

• Regardless of age: 0.5 mg Midalozam per kg BW (intravenous, 15 mg maximum)
• If patient has history of PONV, 0.40 mg Emend per kg BW (pill), and 2 mg Midazolam (intravenous), and/or Scopolamine patch
• If patient has history of anxiety or PTSD, or exhibits anxiety symptoms before surgery:

0.1 mg Valium per kg BW (maximum 10 mg)

Intra-operatively:

• Amounts discretionary by patient vitals 0.5-1.0 mg Lidocaine per kg BW (intravenous -- no maximum) 3-4 mg Propofol per kg BW (no maximum) 1-2 mcg Fentanyl per kg BW (no maximum) 0.35 mg Ketamine per kg BW (no maximum) 0.1 mg Dexamethasone per kg BW (no maximum) If necessary: 0.004 - 0.006 mg Hydromorphone per kg BW (no maximum)
• Local Infiltration:

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:

• 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

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:

• Days 1-3: Alternate weight-adjusted Acetaminophen and 10 mg Ketorolac every 3 hours
• Days 4-7: Alternate weight-adjusted Acetaminophen and Ibuprofen every 3 hours
• Days 1-5: 40 mg Famotidine every 12 hours
• Rescue: Weight-adjusted Tramadol taken with Acetaminophen for severe pain (every 6 hours, maximum 8 doses) We will enroll 80 patients in each treatment group with 65 in each group needed for a sufficiently powered analysis. Patients will not be informed of their treatment group until after the study is complete.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Ropivacaine 0.2% Injectable Solution

Intervention Type: 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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Naropin

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Scottish Rite Hospital for Children

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Scottish Rite Hospital for Children

Locations

Texas Scottish Rite Hospital for Children

Frisco, Texas, United States

Countries

United States

Central Contacts

Robert Van Pelt, MPH

Role: CONTACT

bobby.vanpelt@tsrh.org

2145597456

Anna Wilhelmy, MS

Role: CONTACT

anna.wilhelmy@tsrh.org

469-857-2109

Facility Contacts

Robert Van Pelt, MPH

Role: primary

bobby.vanpelt@tsrh.org

214-559-7456

Anna Wilhelmy, MS

Role: backup

anna.wilhelmy@tsrh.org

469-857-2109

Other Identifiers

STU-2024-0774

Identifier Type: -

Identifier Source: org_study_id