ACL TearNCT04721119
Comparing Adductor Canal Block and Adductor Canal Block-Local Infiltration Analgesia for Post-operative Pain Management
A study testing Local Infiltration Anesthetic and Local Infiltration Anesthetic + Adductor Canal Block in people with ACL Tear and ACL, run by Ottawa Hospital Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- ACL Tear, ACL, ACL Injury
- What is being tested?
- Local Infiltration Anesthetic and Local Infiltration Anesthetic + Adductor Canal Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- English speaking or any other language with possibility of adequate translation
- ASA I-III patients
- Age 18-50
- BMI ≤ 38 kg/m2
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- ACL Tear, ACL, ACL Injury
- Being tested
- Local Infiltration Anesthetic, Local Infiltration Anesthetic + Adductor Canal Block
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Infiltration AnestheticProcedure or surgery
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 + Adductor Canal BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Local Infiltration Anesthetic | Experimental | This group of patients will receive the local infiltration anesthetic only. Receives: 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. Receives: Procedure: Local Infiltration Anesthetic + Adductor Canal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral morphine equivalent consumption
Cumulative oral morphine equivalent consumption over 24 hours post-op
Measured: Up to 24-hours after surgery
Quadriceps motor strength
Percent decrease in quadriceps motor strength at 30 minutes following anesthesia compared to baseline
Measured: Pre-op, 30 minutes post-anesthesia
Secondary outcomes (6)
inta-operative opioid consumption
Cumulative amount of opioids consumed during surgery
Measured: during surgery
Oral morphine equivalent consumption in PACU
Cumulative oral morphine equivalent consumed in PACU
Measured: PACU admission to PACU discharge (approximately 4 hours)
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
Measured: Up to 24 hours post-operative
Quality of Recovery
Measured using the QoR-15 questionnaire at 24 hours post-op
Measured: At 24 hours post-operative
Time in hospital
Time from admission to discharge
Measured: From hospital admission to hospital discharge (approximately 12 hours)
Nerve Block Complications
Presence or absence of nerve block complications
Measured: up to 24 hours post-operative, up to 2 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study startFeb 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACL TearStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721119
- Sponsor's protocol ID
- 2382
- Status last verified
- Jan 2021
- First submitted
- 19 Aug 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ojaghi R, Locke E, Elmi P, Pickell M. Adductor Canal Block and Local Anesthetic Versus Local Anesthetic Alone in ACL Reconstruction: A Double-Blind Randomized Controlled Trial. Am J Sports Med. 2026 Aug 3:3635465261464409. doi: 10.1177/03635465261464409. Online ahead of print.
PubMed 42544937
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04721119
- Acronym / sponsor ID
- 2382
- Conditions
- ACL Tear, ACL, ACL Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Infiltration Anesthetic | Experimental | Procedure: Local Infiltration AnestheticThis group of patients will receive the local infiltration anesthetic only. |
| Local Infiltration Anesthetic + Adductor Canal Block | Experimental | Procedure: Local Infiltration Anesthetic + Adductor Canal BlockThis group of patients will receive the local infiltration anesthetic and adductor canal block combination. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- English speaking or any other language with possibility of adequate translation
- ASA I-III patients
- Age 18-50
- BMI ≤ 38 kg/m2
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local Infiltration AnestheticFor 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. | Procedure or surgery | Local Infiltration Anesthetic |
| Local Infiltration Anesthetic + Adductor Canal BlockFor 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. | Procedure or surgery | Local Infiltration Anesthetic + Adductor Canal Block |
Primary outcome
Oral morphine equivalent consumption
Time frame: Up to 24-hours after surgery
Cumulative oral morphine equivalent consumption over 24 hours post-op
Quadriceps motor strength
Time frame: Pre-op, 30 minutes post-anesthesia
Percent decrease in quadriceps motor strength at 30 minutes following anesthesia compared to baseline
6 secondary outcomes
inta-operative opioid consumption
Time frame: during surgery
Oral morphine equivalent consumption in PACU
Time frame: PACU admission to PACU discharge (approximately 4 hours)
Post-operative Pain
Time frame: Up to 24 hours post-operative
Quality of Recovery
Time frame: At 24 hours post-operative
Time in hospital
Time frame: From hospital admission to hospital discharge (approximately 12 hours)
Nerve Block Complications
Time frame: up to 24 hours post-operative, up to 2 weeks post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Derived from this study: PubMed 42544937Ojaghi R, Locke E, Elmi P, Pickell M. Adductor Canal Block and Local Anesthetic Versus Local Anesthetic Alone in ACL Reconstruction: A Double-Blind Randomized Controlled Trial. Am J Sports Med. 2026 Aug 3:3635465261464409. doi: 10.1177/03635465261464409. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Local Infiltration Anesthetic and Local Infiltration Anesthetic + Adductor Canal Block in people with ACL Tear and ACL, run by Ottawa Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meaghan Dufresne (613-737-8899 ext. 73032, meadufresne@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral morphine equivalent consumption (time frame: Up to 24-hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04721119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.