search
Back to results

Comparing Adductor Canal Block and Adductor Canal Block-Local Infiltration Analgesia for Post-operative Pain Management

Primary Purpose

ACL Tear, ACL, ACL Injury

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Local Infiltration Anesthetic
Local Infiltration Anesthetic + Adductor Canal Block
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL Tear

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Local Infiltration Anesthetic

    Local Infiltration Anesthetic + Adductor Canal Block

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Oral morphine equivalent consumption
    Cumulative oral morphine equivalent consumption over 24 hours post-op
    Quadriceps motor strength
    Percent decrease in quadriceps motor strength at 30 minutes following anesthesia compared to baseline

    Secondary Outcome Measures

    inta-operative opioid consumption
    Cumulative amount of opioids consumed during surgery
    Oral morphine equivalent consumption in PACU
    Cumulative oral morphine equivalent consumed in PACU
    Post-operative Pain
    area under the curve for rest pain scores during the first 24 hours post-op, using the numeric pain rating scale from 0-10, with 0 being no pain and 10 being the worst possible pain
    Quality of Recovery
    Measured using the QoR-15 questionnaire at 24 hours post-op
    Time in hospital
    Time from admission to discharge
    Nerve Block Complications
    Presence or absence of nerve block complications

    Full Information

    First Posted
    August 19, 2020
    Last Updated
    January 20, 2021
    Sponsor
    Ottawa Hospital Research Institute
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04721119
    Brief Title
    Comparing Adductor Canal Block and Adductor Canal Block-Local Infiltration Analgesia for Post-operative Pain Management
    Official Title
    Comparison of the Effectiveness of Adductor Canal Block Versus Combination of Adductor Canal Block and Local Infiltration Analgesia: A Randomized Controlled Trial of the Effect on Postoperative Analgesia and Motor Power
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2021 (Anticipated)
    Primary Completion Date
    August 2021 (Anticipated)
    Study Completion Date
    November 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ottawa Hospital Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ACL Tear, ACL, ACL Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Local Infiltration Anesthetic
    Arm Type
    Experimental
    Arm Description
    This group of patients will receive the local infiltration anesthetic only.
    Arm Title
    Local Infiltration Anesthetic + Adductor Canal Block
    Arm Type
    Experimental
    Arm Description
    This group of patients will receive the local infiltration anesthetic and adductor canal block combination.
    Intervention Type
    Procedure
    Intervention Name(s)
    Local Infiltration Anesthetic
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Local Infiltration Anesthetic + Adductor Canal Block
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Oral morphine equivalent consumption
    Description
    Cumulative oral morphine equivalent consumption over 24 hours post-op
    Time Frame
    Up to 24-hours after surgery
    Title
    Quadriceps motor strength
    Description
    Percent decrease in quadriceps motor strength at 30 minutes following anesthesia compared to baseline
    Time Frame
    Pre-op, 30 minutes post-anesthesia
    Secondary Outcome Measure Information:
    Title
    inta-operative opioid consumption
    Description
    Cumulative amount of opioids consumed during surgery
    Time Frame
    during surgery
    Title
    Oral morphine equivalent consumption in PACU
    Description
    Cumulative oral morphine equivalent consumed in PACU
    Time Frame
    PACU admission to PACU discharge (approximately 4 hours)
    Title
    Post-operative Pain
    Description
    area under the curve for rest pain scores during the first 24 hours post-op, using the numeric pain rating scale from 0-10, with 0 being no pain and 10 being the worst possible pain
    Time Frame
    Up to 24 hours post-operative
    Title
    Quality of Recovery
    Description
    Measured using the QoR-15 questionnaire at 24 hours post-op
    Time Frame
    At 24 hours post-operative
    Title
    Time in hospital
    Description
    Time from admission to discharge
    Time Frame
    From hospital admission to hospital discharge (approximately 12 hours)
    Title
    Nerve Block Complications
    Description
    Presence or absence of nerve block complications
    Time Frame
    up to 24 hours post-operative, up to 2 weeks post-operative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: English speaking or any other language with possibility of adequate translation ASA I-III patients Age 18-50 BMI ≤ 38 kg/m2 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Meaghan Dufresne
    Phone
    613-737-8899
    Ext
    73032
    Email
    meadufresne@ohri.ca

    12. IPD Sharing Statement

    Learn more about this trial

    Comparing Adductor Canal Block and Adductor Canal Block-Local Infiltration Analgesia for Post-operative Pain Management

    We'll reach out to this number within 24 hrs