Sciatic Technique Comparison of Nerve Blockade for Pain Control Following Hamstring Autograft Harvest in Adolescents

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament (ACL) Tear
• Interventions: Drug: Continuous sciatic PNB; Drug: Single-injection sciatic PNB

• Registration Number: NCT02947633
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Detailed Description

SPECIFIC AIM 1. The first aim of the study is to explore the impact of sciatic PNB technique on hamstring donor site pain control postoperatively.

H1.a. The extended duration of analgesia offered by continuous sciatic PNB decreases pain scores during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB.

H1.b. The extended duration of analgesia offered by continuous sciatic PNB decreases oral pain medication use during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB.

H1.c. The extended duration of analgesia offered by continuous sciatic PNB decreases the incidence of unplanned admission due to poor pain control during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB.

SPECIFIC AIM 2. The second aim of the study is to explore the impact of sciatic PNB technique on active knee flexion postoperatively.

H2. The extended duration of analgesia offered by continuous sciatic PNB does not delay active knee flexion during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB.

SPECIFIC AIM 3. The third aim of the study is to explore the impact of sciatic PNB technique on patient satisfaction with postoperative pain control.

H3.1. The extended duration of analgesia offered by continuous sciatic PNB improves patient satisfaction during the initial 72 hours following hamstring autograft harvest when compared to single-injection sciatic PNB.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-28
• Status Verified: 2024-04
• Primary Completion: 2024-04
• Study Completion: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous sciatic PNB	Continuous sciatic PNB	If a CPI catheter is placed, the CPI catheter will be placed under ultra-sound guidance, with the tip of the catheter being placed immediately adjacent to the sciatic nerve, after the local anesthesia has been deposited. CPI catheters will only remain in-situ for 48 hours.
Single-injection sciatic PNB	Single-injection sciatic PNB	Under ultrasound-guidance, the sciatic nerve can readily be identified in the posterior thigh. The nerve appears hyperechoic and can be traced distally to the popliteal fossa, where it divides into the tibial and common peroneal nerves. Local anesthesia is injected under real-time visualization following a negative aspiration. If a single-injection block is done, local anesthesia is deposited adjacent to the sciatic nerve within the fascial plane, but not within the epineurium. As such, single-injection sciatic PNB, which can last up to 24 hours, should provide adequate analgesia precluding the need for oral narcotic or nonsteroidal anti-inflammatory medications following ACL reconstruction with a hamstring autograft.

Primary Outcome Measures

Name	Time	Method
Pain Reduction	72 Hours	Guardian collects pain data for 72 hours post ACL through self-reported pain scores.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States