N/A
N=141
Sciatic Technique Comparison of Nerve Blockade for Pain Control Following Hamstring Autograft Harvest in Adolescents
Anterior Cruciate Ligament (ACL) Tear
Bottom Line
View on ClinicalTrials.gov: NCT02947633 ↗Enrolled (actual)
141
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Pain Reduction — 1.438; 2.615 Numerical Rating Scale (NRS) — p=0.065123
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Single-injection sciatic PNB (Drug); Continuous sciatic PNB (Drug)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Reduction |
1.438; 2.615 | 0.065123 |
Summary
The purpose of this research is to compare the effect of single-injection sciatic PNB to continuous sciatic PNB on 1) postoperative pain control as measured by self-reported pain scores, pain medication use, and unplanned hospital admission due to poor pain control, 2) active knee flexion, and 3) patient satisfaction with pain control following ACL reconstruction with a hamstring autograft. The results of this research have the potential to positively impact pain control for the adolescent population undergoing this surgical procedure and foster responsible utilization of limited resources.
Eligibility Criteria
Inclusion Criteria
A subject may be INCLUDED in this study if:
- The subject is male or female;
- The subject is of any racial or ethnic group;
- The subject is age 10 years to 18 years (inclusive);
- The subject is scheduled for the following: Unilateral ACL reconstruction with a hamstring autograft under general anesthesia on an outpatient basis, and not being performed in conjunction with any other surgical procedures;
- The subject is American Society of Anesthesiologists (ASA) patient classification I-II;
- The subject or legally authorized representative has consented to femoral and sciatic peripheral nerve blockade for the procedure and the consent for peripheral nerve blockade has been obtained by a clinician (MD, DO, CRNA or APN) authorized to obtain consent;
- The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.
Exclusion Criteria
A subject will be EXCLUDED from this study if:
- Additional surgical procedures are being performed concurrently;
- The subject is ASA classification > II;
- The subject has pre-existing allergies to amide local anesthetics;
- The subject receives sedation preoperatively;
- The subject is schedule for overnight hospital admission;
- The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study, including but not limited to coagulopathy, preexisting central or peripheral nervous systems disorders, and local infection or sores at the anticipated site of needle insertion;
- Unsuccessful PNB or CPI catheter placement occurs during the study. -
Data sourced from ClinicalTrials.gov (NCT02947633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.