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
About this trial
This is an interventional treatment trial for ACL Tear
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
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
NCT ID
NCT04721119
First Posted
August 19, 2020
Last Updated
January 20, 2021
Sponsor
Ottawa Hospital Research Institute
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
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