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

NCT02947633 | Completed Results

• 1 other identifier: 2014-6533
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament (ACL) Tear

Outcome Measures

Primary Outcomes (1)

• Pain Reduction

  Guardian collects Numeric Rating Scale (NRS) pain score. The range is 0 - 10. 0 being no pain, 10 being the worst pain imaginable.

  72 Hours

Study Arms (2)

Continuous sciatic PNB

EXPERIMENTAL

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.

Drug: Continuous sciatic PNB

Single-injection sciatic PNB

ACTIVE COMPARATOR

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.

Drug: Single-injection sciatic PNB

Interventions

Single-injection sciatic PNB DRUG

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.

Single-injection sciatic PNB

Continuous sciatic PNB DRUG

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.

Continuous sciatic PNB

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (17)

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MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Marc Mecoli
• Organization: Cincinnati Children's Hospital

marc.mecoli@cchmc.org

513-636-4200

Study Officials

• Jamie Furstein, CRNA

  AANA Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: October 28, 2016
• Study Start: March 1, 2015
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 22, 2026
• Results First Posted: April 22, 2026

Record last verified: 2026-04

Locations

US (1)