ClinicalTrials.gg
CompletedNCT02947633Updated Apr 22, 2026Results posted

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

An interventional study of Single-injection sciatic PNB and Continuous sciatic PNB in Anterior Cruciate Ligament (ACL) Tear, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Mar 2015, registered Nov 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
141
Allocation
Randomized
Ages
10 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 60 studies in Lacerations with a site in United States — 12 open to participants now, 14 under way, 1 of them phase 3. Lacerations · United States.

Enrollment
10th of 52
141 · median 52
Started
2015
the only one that year
No phase
33 of 60
5 open now
Registered
24th of 60
by date

Among the 60 studies in Lacerations with a site in United States, this one is the 10th largest by enrollment of the 52 interventional ones, is the only one that started in 2015, is one of 33 with no phase, and was the 24th registered.

By phase

60 studies; the count open now beside each. This study's row is marked.

No phasethis study33 · 5 open
Phase 410 · 2 open
Observational7 · 2 open
Phase 26 · 1 open
Phase 11 · 1 open
Phase 1/21 · 0 open
Phase 2/31 · 0 open
Phase 31 · 1 open

By the year they started

First in 2000; this study’s year is marked. 1 started in 2015.

Size and results

Median enrollment 52 across the 52 interventional studies, 50 across the 7 observational. Of the 36 that completed or were terminated, 18 (50%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 60 studies in Lacerations with a site in United States, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Anterior Cruciate Ligament (ACL) Tear

Browse trials for

04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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 to participate in the study and when appropriate, the subject has given assent or consent to participate.

Exclusion criteria

Exclusion Criteria:

A subject will be EXCLUDED from this study if:

  1. Additional surgical procedures are being performed concurrently;
  2. The subject is > 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. -
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
141 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Continuous sciatic PNB

  • Active comparator
    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.

    Drug: Single-injection sciatic PNB

Interventions

  • DrugSingle-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.

  • DrugContinuous 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.

06

What researchers measure

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.

    Time frame: 72 Hours

07

Results

Posted Apr 22, 2026

Participant flow

141 patients were enrolled in the study. Enrollment was to include 140 participants. I believe one patient was recruited accidentally. However, 123 patients completed the study, and 18 patients were withdrawn.

Participant flow — Overall Study
MilestoneExperimental : Continuous Sciatic PNB,Active Comparator : Single-injection Sciatic PNB
Started6675
Completed6357
Not completed318
Withdrew: Withdrawal by subject318

Outcome measures

PrimaryPain Reduction

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

Time frame:
72 Hours
Reported as:
Mean · Numerical Rating Scale (NRS)
Pain Reduction
Numerical Rating Scale (NRS)Continuous Sciatic PNBSingle-injection Sciatic PNB
Pain Reduction1.438 ± 1.6712.615 ± 2.836
Statistical analysis
  • Continuous Sciatic PNB vs Single-injection Sciatic PNB · Wilcoxon (Mann-Whitney) · p = 0.065123 · Mean difference (net): 1.177

Adverse events

Collected over From enrollment to 72 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Continuous Sciatic PNB0/63 (0%)0/63 (0%)0/63 (0%)
Single-injection Sciatic PNB0/57 (0%)0/57 (0%)0/57 (0%)

Baseline characteristics

18 participants were withdrawn

Age, Categorical
Age, Categorical(Participants)Continuous Sciatic PNBSingle-injection Sciatic PNBTotal
<=18 years369
Between 18 and 65 years6369132
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Continuous Sciatic PNBSingle-injection Sciatic PNBTotal
Female373572
Male294069
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Continuous Sciatic PNBSingle-injection Sciatic PNBTotal
Count of participants——0
08

Study locations

1 site
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
09

References and documents

Publications

  • Agin CW, Glass PSA. Tolerance and aging: optimizing analgesia in pain management. Anesth Analg. 2005 Jun;100(6):1731-1732. doi: 10.1213/01.ANE.0000152203.17541.16. No abstract available. PubMed 15920205 ↗
  • Beales JG, Holt PJ, Keen JH, Mellor VP. Children with juvenile chronic arthritis: their beliefs about their illness and therapy. Ann Rheum Dis. 1983 Oct;42(5):481-6. doi: 10.1136/ard.42.5.481. PubMed 6625698 ↗
  • Bushnell BD, Sakryd G, Noonan TJ. Hamstring donor-site block: evaluation of pain control after anterior cruciate ligament reconstruction. Arthroscopy. 2010 Jul;26(7):894-900. doi: 10.1016/j.arthro.2009.11.022. Epub 2010 May 13. PubMed 20620788 ↗
  • Distad BJ, Weiss MD. Clinical and electrodiagnostic features of sciatic neuropathies. Phys Med Rehabil Clin N Am. 2013 Feb;24(1):107-20. doi: 10.1016/j.pmr.2012.08.023. Epub 2012 Oct 31. PubMed 23177034 ↗
  • Frost S, Grossfeld S, Kirkley A, Litchfield B, Fowler P, Amendola A. The efficacy of femoral nerve block in pain reduction for outpatient hamstring anterior cruciate ligament reconstruction: a double-blind, prospective, randomized trial. Arthroscopy. 2000 Apr;16(3):243-8. doi: 10.1016/s0749-8063(00)90047-1. PubMed 10750003 ↗
  • Gagnier JJ, Morgenstern H, Chess L. Interventions designed to prevent anterior cruciate ligament injuries in adolescents and adults: a systematic review and meta-analysis. Am J Sports Med. 2013 Aug;41(8):1952-62. doi: 10.1177/0363546512458227. Epub 2012 Sep 12. PubMed 22972854 ↗
  • Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. PubMed 18929686 ↗
  • Mathews L. Pain in children: neglected, unaddressed and mismanaged. Indian J Palliat Care. 2011 Jan;17(Suppl):S70-3. doi: 10.4103/0973-1075.76247. PubMed 21811376 ↗
  • Mehta VM, Mandala C, Foster D, Petsche TS. Comparison of revision rates in bone-patella tendon-bone autograft and allograft anterior cruciate ligament reconstruction. Orthopedics. 2010 Jan;33(1):12. doi: 10.3928/01477447-20091124-15. PubMed 20055340 ↗
  • Pallis M, Svoboda SJ, Cameron KL, Owens BD. Survival comparison of allograft and autograft anterior cruciate ligament reconstruction at the United States Military Academy. Am J Sports Med. 2012 Jun;40(6):1242-6. doi: 10.1177/0363546512443945. Epub 2012 Apr 24. PubMed 22534281 ↗
  • Pinczewski LA, Lyman J, Salmon LJ, Russell VJ, Roe J, Linklater J. A 10-year comparison of anterior cruciate ligament reconstructions with hamstring tendon and patellar tendon autograft: a controlled, prospective trial. Am J Sports Med. 2007 Apr;35(4):564-74. doi: 10.1177/0363546506296042. Epub 2007 Jan 29. PubMed 17261567 ↗
  • Shaw T, Williams MT, Chipchase LS. Do early quadriceps exercises affect the outcome of ACL reconstruction? A randomised controlled trial. Aust J Physiother. 2005;51(1):9-17. doi: 10.1016/s0004-9514(05)70048-9. PubMed 15748120 ↗
  • Silvers HJ, Mandelbaum BR. Prevention of anterior cruciate ligament injury in the female athlete. Br J Sports Med. 2007 Aug;41 Suppl 1(Suppl 1):i52-9. doi: 10.1136/bjsm.2007.037200. Epub 2007 Jul 3. PubMed 17609222 ↗
  • Tran KM, Ganley TJ, Wells L, Ganesh A, Minger KI, Cucchiaro G. Intraarticular bupivacaine-clonidine-morphine versus femoral-sciatic nerve block in pediatric patients undergoing anterior cruciate ligament reconstruction. Anesth Analg. 2005 Nov;101(5):1304-1310. doi: 10.1213/01.ANE.0000180218.54037.0B. PubMed 16243985 ↗
  • Twycross A. Educating nurses about pain management: the way forward. J Clin Nurs. 2002 Nov;11(6):705-14. doi: 10.1046/j.1365-2702.2002.00677.x. PubMed 12427174 ↗
  • Wegener JT, van Ooij B, van Dijk CN, Hollmann MW, Preckel B, Stevens MF. Value of single-injection or continuous sciatic nerve block in addition to a continuous femoral nerve block in patients undergoing total knee arthroplasty: a prospective, randomized, controlled trial. Reg Anesth Pain Med. 2011 Sep-Oct;36(5):481-8. doi: 10.1097/AAP.0b013e318228c33a. PubMed 21857273 ↗
  • Kimberlin CL, Winterstein AG. Validity and reliability of measurement instruments used in research. Am J Health Syst Pharm. 2008 Dec 1;65(23):2276-84. doi: 10.2146/ajhp070364. PubMed 19020196 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2015 to primary completion in Apr 2024, 109 months.

Results were first posted in Apr 2026, 2 years after primary completion.

Of 46 non-industry interventional studies with no phase under Lacerations, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 72. This study's 109 months is above that.

Counting every sponsor, half of 50 studies reached it within 19 months; a quarter within 12 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 11, 2015
First posted
Oct 28, 2016
StartActual
Mar 2015
Primary completionActual
Apr 2024
CompletionActual
Apr 2024
Results first posted
Apr 22, 2026
Last update
Apr 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02947633
Responsible party
Sponsor
First posted
Oct 28, 2016
Start date
Mar 2015
Primary completion
Apr 2024
Completion
Apr 2024
Results posted
Apr 22, 2026
Last update
Apr 22, 2026

Study contacts

Jamie Furstein, CRNA
principal investigator · AANA Foundation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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