Clinical trial NCT06559137: Evaluation of Pain Management After Surgery When Using Nerve Blocks in the Pediatric Population
Official title: Prospective Evaluation of Post-operative Pain Management Using Peripheral Nerve Blocks in the Pediatric Population
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
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
Lead sponsor: Texas Scottish Rite Hospital for Children
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 160
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (participant) randomized controlled trial to investigate the safety and pain-control efficacy and patient reported pain outcomes of PNBs in youth receiving anterior cruciate ligament reconstruction (ACLR). 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 participants. The randomization technique of this study is supported by the equipoise of this institution's physicians regarding peripheral nerve blocks and the quantity of participants who this study's results will affect.

Participant will be approached pre-operatively for participation, after which the surgical team will be informed. Participants will be offered the choice to participate in the study and randomize their treatment group. If participants do not want their treatment to be randomized, they will not be included in the study. Participants enrolled in this study will receive either a single-shot ropivacaine peripheral nerve block intraoperatively or no single-shot ropivacaine peripheral nerve block intraoperatively during their ACL reconstruction surgery. At post-operative days 1, 4 and 7, participants will receive and complete questionnaires regarding their pain scores, levels, and outcomes, effective pain treatments, overall pain interference, narcotic use (number of pills taken), and overall pain treatment satisfaction. Additionally, participants may receive and complete secondary outcome measures of functional and psychological outcomes regarding their ACL reconstruction surgery.

As per the institutional pain management protocol, participants will receive the following anesthesia doses by body weight (BW):

Pre-operatively:

* Regardless of age: 0.5 mg midazolam per kg BW (intravenous, 15 mg maximum)
* If patient has history of post-operative nausea and vomiting (PONV), 0.40 mg Emend per kg BW (pill), and 2 mg midazolam (intravenous)

Intra-operatively:

* 0.5-1.0 mg Lidocaine per kg BW (intravenous, 80 mg maximum)
* 3-4 mg Propofol per kg BW
* 1-2 mcg Fentanyl per kg BW (maximum 100 mcg)
* 0.35 mg Ketamine per kg BW (single dose or titration)
* 0.1 mg Dexamethasone per kg BW (maximum 10 mg)

Local Infiltration:

* If \< 40 kg: 4 mg Exparel per kg BW and 30 mL 0.9% normal saline
* If 40-70 kg: 10 mL Exparel, 10 mL 0.25% Marcaine, and 10 mL 0.9% normal saline
* If \> 70 kg: 20 mL Exparel and 10 mL 0.25% Marcaine

Optional:

* 10-20 mcg Dexmedetomidine per kg BW (for persistent tachycardia)
* If intubated/ventilated: 0.5-0.6 mg Rocuronium per kg BW, \~2 mg/kg sugammadex 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 hydromorphone 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 post-anesthesia care unit (PACU) (Phase 1) medication required: 0.004-0.006 mg hydromorphone per kg BW and 0.10-0.15 mg Oxycodone per kg BW
* If PACU (Phase 2) medication required: Metoclopramide, Dexamethasone, Promethazine, or Ondansetron

Peripheral Nerve Block Group Only:

* Patients will receive a purple surgical marker dot at the decided site of injection
* A 20 mL Adductor PNB will be injected at the point of the purple dot
* Patient will receive 0.2% plain Ropivacaine (perineural injection) regardless of weight

Placebo Group Only:

* Patients will receive a purple surgical marker dot at a point where a PNB would be injected, if they were randomized to the placebo group
* A bandage will be placed over the purple dot and wrapped with the standard gauze/bandage from the surgery

Post-Operatively:

* If ≤ 12 years:
* Alternate weight-adjusted Acetaminophen and Ibuprofen every 3 hours
* Rescue: Weight-adjusted Acetaminophen/Hydrocodone substituted for Acetaminophen for severe pain (every 6 hours, maximum 8 doses)
* If \> 12 years:
* 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)

The investigators will enroll 80 participants in each treatment group with 65 in each group needed for a sufficiently powered analysis.

Eligibility criteria: Inclusion Criteria:

* Must be aged 12+ 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 \<12 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

Primary outcomes:
measure: Visual Analog Scale (VAS) Wong-Baker Face Pain Scale
timeFrame: Postoperative days 1, 4, and 7
measure: Visual Analog Scale (VAS) 10-centimeter line 0-10 Numeric Pain Intensity Scale
timeFrame: Postoperative days 1, 4, and 7
measure: Scottish Rite for Children-developed pain questionnaire
timeFrame: Postoperative days 1, 4, and 7
measure: Pain Management Patient Satisfaction questionnaire
timeFrame: Postoperative day 7
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Scale v1.0 - Global Health 7+2
timeFrame: Preoperatively and within one week postoperatively.
Other outcomes:
Locations:
city: Frisco
country: United States
facility: Texas Scottish Rite Hospital for Children
state: Texas
Study officials:
affiliation: Texas Scottish Rite Hospital for Children
name: Philip Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References: