Clinical trial
Sciatic Peripheral Nerve Blockade for Pain Control Following Hamstring Autograft Harvest in Adolescents: A Comparison of Two Techniques
Name
2014-6533
Description
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.
Trial arms
Trial start
2015-03-01
Estimated PCD
2024-04-01
Trial end
2024-04-01
Status
Completed
Treatment
Single-injection sciatic PNB
Single-injection sciatic PNB is a regional anesthetic technique employed to anesthetize the sciatic nerve with a single dose of local anesthetic. This technique offers pain control for a limited amount of time based on the volume and concentration of local anesthetic used.
Arms:
Single-injection sciatic PNB
Continuous sciatic PNB
Continuous sciatic PNB entails placing a continuous perineural infusion (CPI) catheter so that local anesthetic may be released slowly but continuously adjacent to the sciatic nerve (perineural) for several days postoperatively. The continuous PNB has the ability to reliably provide analgesia on subsequent postoperative days.
Participants my be randomized to receive an additional experimental continuous pain ball during surgery which can provide up to 48 hours of pain relief.
Arms:
Continuous sciatic PNB
Size
141
Primary endpoint
Pain Reduction
72 Hours
Eligibility criteria
Inclusion Criteria:
A subject may be INCLUDED in this study if:
1. The subject is male or female;
2. The subject is of any racial or ethnic group;
3. The subject is age 10 years to 18 years (inclusive);
4. 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;
5. The subject is American Society of Anesthesiologists (ASA) patient classification I-II;
6. 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;
7. 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:
1. Additional surgical procedures are being performed concurrently;
2. The subject is ASA classification \> II;
3. The subject has pre-existing allergies to amide local anesthetics;
4. The subject receives sedation preoperatively;
5. The subject is schedule for overnight hospital admission;
6. 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;
7. Unsuccessful PNB or CPI catheter placement occurs during the study. -
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 141, 'type': 'ACTUAL'}}
Updated at
2024-04-02
1 organization
2 products
1 indication
Organization
Children's Hospital Medical CenterProduct
Single-injection sciatic PNBIndication
ACL TearProduct
Continuous sciatic PNB