NCT04721119

Brief Summary

Anterior cruciate ligament (ACL) reconstruction is one of the most commonly performed surgeries amongst young orthopedic surgery patients. Optimal post-operative pain control helps to reduce the opioid burden and to improve the patient's experience. Regional anesthesia, such as the femoral nerve block (FNB) and adductor canal block (ACB), are commonly used for post-operative pain control after surgery. The ACB has replaced the FNB. This is because the ACB targets the femoral nerve, while avoiding the numbing effects on quadricep muscle strength that make it difficult to move the leg. Another form of pain control is local infiltration anesthesia (LIA), which directly blocks pain in the knee. Similar to the ACB, it avoids the numbing effects on the quadricep muscle.This can help improve patient safety and experience by reducing risks of falls and allowing the patient to move earlier. This can also be associated with decreased time in the hospital and decreased costs. Technically, it is less complex and can be done the shorter period of time. The purpose of this study is to refine the pain management technique following anterior cruciate ligament surgery. More specifically, the aim of this study is to evaluate the effects of LIA alone, and a LIA-ACB combination on post-operative pain and thigh muscle strength.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

August 19, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

August 19, 2020

Last Update Submit

January 20, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Oral morphine equivalent consumption

    Cumulative oral morphine equivalent consumption over 24 hours post-op

    Up to 24-hours after surgery

  • Quadriceps motor strength

    Percent decrease in quadriceps motor strength at 30 minutes following anesthesia compared to baseline

    Pre-op, 30 minutes post-anesthesia

Secondary Outcomes (6)

  • inta-operative opioid consumption

    during surgery

  • Oral morphine equivalent consumption in PACU

    PACU admission to PACU discharge (approximately 4 hours)

  • Post-operative Pain

    Up to 24 hours post-operative

  • Quality of Recovery

    At 24 hours post-operative

  • Time in hospital

    From hospital admission to hospital discharge (approximately 12 hours)

  • +1 more secondary outcomes

Study Arms (2)

Local Infiltration Anesthetic

EXPERIMENTAL

This group of patients will receive the local infiltration anesthetic only.

Procedure: Local Infiltration Anesthetic

Local Infiltration Anesthetic + Adductor Canal Block

EXPERIMENTAL

This group of patients will receive the local infiltration anesthetic and adductor canal block combination.

Procedure: Local Infiltration Anesthetic + Adductor Canal Block

Interventions

For the local infiltration anesthetic, patients will receive 20 cc of 0.5% ropivacaine, by intra-articular injection performed by the surgeon. The injection is done at the end of the surgical procedure, after suturing the incision.

Local Infiltration Anesthetic

For the local infiltration anesthetic, patients will receive 20 cc of 0.25% ropivacaine, by intra-articular injection performed by the surgeon. The injection is done at the end of the surgical procedure, after suturing the incision. For the adductor canal block, patients will receive 20 cc of 0.25% ropivicaine, through injection performed by the anesthesiologist. The injection is done under the sartorius muscle, in mid-thigh, using ultrasound guidance.

Local Infiltration Anesthetic + Adductor Canal Block

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • English speaking or any other language with possibility of adequate translation
  • ASA I-III patients
  • Age 18-50
  • BMI ≤ 38 kg/m2

You may not qualify if:

  • Refusal or inability to provide informed consent
  • Any contraindication to regional anesthesia including coagulopathy or bleeding diathesis,
  • Allergy to local anesthetics, or infection at the site of the block
  • History of long-term opioid intake (more than 3 months use) or chronic pain disorder (more than 3 months)
  • History of preexisting neuropathy in the operative leg
  • Revision of ACL repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Central Study Contacts

Meaghan Dufresne

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 19, 2020

First Posted

January 22, 2021

Study Start

February 1, 2021

Primary Completion

August 1, 2021

Study Completion

November 1, 2021

Last Updated

January 22, 2021

Record last verified: 2021-01