Skip to main content
OpenTrials
Completed

NCT Number: NCT02947633

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain Reduction

    Time frame: 72 Hours

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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Sciatic Peripheral Nerve Blockade for Pain Control Following Hamstring Autograft Harvest in Adolescents: A Comparison of Two Techniques

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2016
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.