NCT03033589

Brief Summary

All patients over the age of 16 undergoing primary or revision anterior cruciate ligament reconstruction with the use of bone-patellar-bone autograft are eligible for the study. Patients will be randomized pre-operatively to receive either an adductor canal nerve block (single injection) or a femoral nerve block (single injection). Post-operatively, the primary outcome measures of pain level using visual analog scale as well as narcotic and non-narcotic analgesic requirements will be measured.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started May 2016

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
8.5 years until next milestone

Results Posted

Study results publicly available

June 23, 2026

Completed
Last Updated

June 23, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

August 24, 2016

Results QC Date

March 23, 2026

Last Update Submit

May 26, 2026

Conditions

Keywords

Pain controlAnterior Cruciate Ligament (ACL_ Reconstruction)Regional Anesthesia

Outcome Measures

Primary Outcomes (2)

  • Average Pain Level Per Arm on the Visual Analog Scale (VAS) at Post-operative (Day 0), Day 1, Day 2, Day 3.

    The VAS is a validated self-reported instrument for measuring pain intensity. Possible scores range from 0 (no pain) to 10 (worse possible pain).

    Post-operative Day 0, Day 1, Day 2, Day 3

  • Average Narcotic Consumption Per Arm in Morphine Equivalents at Post-operative (Day 0), Day 1, Day 2, Day 3.

    Norco 5-325 (hydrocodone with acetaminophen) oral tablet prescribed (1-2 tablets every 4-6 hours as needed for pain) converted to intravenous morphine equivalent dosing.

    Post-operative Day 0, Day 1, Day 2, Day 3

Study Arms (2)

Adductor Canal Nerve Block

ACTIVE COMPARATOR

One hour prior to procedure, subject to receive 20 mL of 0.5% ropivacaine injected into the sheath of the saphenous nerve at the adductor hiatus. Ultrasound guidance utilized for appropriate localization of the targeted nerve sheath for local infiltration. No nerve stimulators to be utilized during or after the procedure.

Drug: Marcaine 0.25 % Injectable Solution

Femoral Nerve block

ACTIVE COMPARATOR

One hour prior to procedure, subject to receive 30 mL of 0.5% ropivacaine injected into the nerve sheath of the femoral nerve at the level of the femoral triangle. Ultrasound guidance utilized for appropriate localization of the targeted nerve sheath for local infiltration. No nerve stimulators to be utilized during or after the procedure.

Drug: Marcaine 0.25 % Injectable Solution

Interventions

For the adductor canal block, 20 mL of 0.25% marcaine will be injected with the use of ultrasound guidance into the adductor canal by the attending anesthesiologist on the case in the pre-op holding area.

Adductor Canal Nerve Block

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary ACL Reconstruction with use of Bone-Patellar-Bone Autograft
  • Age 16 or older

You may not qualify if:

  • Patients under 16
  • The use of Allograft,
  • The use of hamstring autograft
  • The use quadriceps autograft
  • Patients allergic to active ingredients in the injection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System - CFP 642

Detroit, Michigan, 48202, United States

Location

Related Publications (4)

  • Guirro UB, Tambara EM, Munhoz FR. Femoral nerve block: Assessment of postoperative analgesia in arthroscopic anterior cruciate ligament reconstruction. Braz J Anesthesiol. 2013 Nov-Dec;63(6):483-91. doi: 10.1016/j.bjane.2013.09.001. Epub 2013 Dec 5.

    PMID: 24565346BACKGROUND
  • Luo TD, Ashraf A, Dahm DL, Stuart MJ, McIntosh AL. Femoral nerve block is associated with persistent strength deficits at 6 months after anterior cruciate ligament reconstruction in pediatric and adolescent patients. Am J Sports Med. 2015 Feb;43(2):331-6. doi: 10.1177/0363546514559823. Epub 2014 Dec 2.

    PMID: 25466410BACKGROUND
  • Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.

    PMID: 24401769BACKGROUND
  • Lynch JR, Okoroha KR, Lizzio V, Yu CC, Jildeh TR, Moutzouros V. Adductor Canal Block Versus Femoral Nerve Block for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial. Am J Sports Med. 2019 Feb;47(2):355-363. doi: 10.1177/0363546518815874. Epub 2018 Dec 17.

MeSH Terms

Conditions

PainAgnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Clinical Trials Office Manager
Organization
Henry Ford Health

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2016

First Posted

January 27, 2017

Study Start

May 1, 2016

Primary Completion

July 31, 2017

Study Completion

December 31, 2017

Last Updated

June 23, 2026

Results First Posted

June 23, 2026

Record last verified: 2026-05

Locations