Sciatic Technique Comparison of Nerve Blockade for Pain Control Following Hamstring Autograft Har… (NCT02947633) | Clinical Trial Compass
CompletedNot Applicable
Sciatic Technique Comparison of Nerve Blockade for Pain Control Following Hamstring Autograft Harvest in Adolescents
United States141 participantsStarted 2015-03
Plain-language 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.
Who can participate
Age range
10 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Reduction
Timeframe: 72 Hours
Trial details
NCT IDNCT02947633
SponsorChildren's Hospital Medical Center, Cincinnati
. 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
. 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. -