NCT03365908

Brief Summary

This study will compare the outcome of pain interventions that are considered standard of care during the surgical treatment of ACL injuries. The comparison will be looking at pain control during and after ACL surgery as well as functional outcomes in patients that had a nerve block versus those who did not. The investigators hypothesize that pain control will be equal between both groups.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

October 9, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

8.7 years

First QC Date

November 27, 2017

Last Update Submit

November 24, 2025

Conditions

Anterior Cruciate Ligament Rupture

Keywords

ACL

Outcome Measures

Primary Outcomes (2)

  • Immediate Post-op Pain Score

    Measured via Visual Analog Scale (VAS) in recovery, scale from 0 (least) to 10 (maximum), no units, with 0 being no pain and 10 being extreme pain

    15 min post-op

  • Opioid Use

    Aggregated amount of narcotic medication used, measured in milligrams

    6 weeks post-op

Secondary Outcomes (4)

  • Short-term Knee Function Post-op

    6 weeks post-op

  • Intermediate-term Knee Function

    12 weeks post-op

  • Long-term Knee Function

    24 weeks post-op

  • Post-anaesthesia care unit (PACU) Time

    Immediately after surgery

Study Arms (2)

Adductor Canal Nerve Block

EXPERIMENTAL

Participant will receive an adductor canal nerve block via 15 mL 0.5% ropivacaine injection prior to OR for ACL reconstruction. Participant will receive pre-op oral medications.

Procedure: Adductor Canal Nerve BlockDrug: Ropivacaine injection

No Nerve Block

NO INTERVENTION

Participant will receive pre-op oral medications but no nerve block prior to OR for ACL reconstruction.

Interventions

Adductor Canal Nerve BlockPROCEDURE

An adductor canal nerve block with 15 mL of 0.5% ropivacaine will be performed pre-operatively by Anesthesiology.

Adductor Canal Nerve Block
Ropivacaine injectionDRUG

15 mL of 0.5% ropivacaine will be administered for the adductor canal block

Adductor Canal Nerve Block

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18 and 45 years old.
  • Clinical and/or advanced imaging confirmation of ACL tear of which reconstructive surgery is recommended and accepted.

You may not qualify if:

  • No prior surgery of the affected and contralateral knee
  • Adults unable to consent
  • Children (age \< 18 years old)
  • Prisoners
  • Pregnant women
  • Inflammatory arthritis
  • Non-English-speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Health

Sacramento, California, 95817, United States

Location

Related Publications (3)

  • Aronowitz ER, Kleinbart FA. Outpatient ACL reconstruction using intraoperative local analgesia and oral postoperative pain medication. Orthopedics. 1998 Jul;21(7):781-4. doi: 10.3928/0147-7447-19980701-07.

    PMID: 9672915BACKGROUND

  • Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.

    PMID: 23241723BACKGROUND

  • Abdallah FW, Whelan DB, Chan VW, Prasad GA, Endersby RV, Theodoropolous J, Oldfield S, Oh J, Brull R. Adductor Canal Block Provides Noninferior Analgesia and Superior Quadriceps Strength Compared with Femoral Nerve Block in Anterior Cruciate Ligament Reconstruction. Anesthesiology. 2016 May;124(5):1053-64. doi: 10.1097/ALN.0000000000001045.

    PMID: 26938989BACKGROUND

Related Links

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Cassandra Lee, MD

    UC-Davis Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Operating surgeon and outcome assessor will be blind to whether patient had nerve block prior to OR.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 7, 2017

Study Start

October 9, 2017

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)