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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age13-21
SponsorTexas Scottish Rite Hospital for Children

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ropivacaine 0.2% Injectable Solution

Treatment groups

160 Participants
are divided into 2 treatment groups