Status:
NOT_YET_RECRUITING
Evaluation of Pain Management After Surgery When Using Nerve Blocks in the Pediatric Population
Lead Sponsor:
Texas Scottish Rite Hospital for Children
Conditions:
Anterior Cruciate Ligament (ACL) Tear
Sports Injuries in Children
Eligibility:
All Genders
13-21 years
Phase:
PHASE2
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 procedur...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06559137
Start Date
September 1 2025
End Date
September 1 2028
Last Update
September 16 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Texas Scottish Rite Hospital for Children
Frisco, Texas, United States, 75034