ACL SurgeryPhase 4NCT03401450

Optimal Location of Nerve Block to Minimize Perioperative Opioid Administration in ACL Surgery: Comparing True Adductor Canal to Proximal Block

A Phase 4 study testing ACB within true AC with bupivacaine 0.5% 20cc and ACB proximal to true AC with bupivacaine 0.5% 20cc in people with ACL Surgery, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospective, randomized, single blinded trial involving human subjects. The goal of this study is to determine an optimal location (proximal or distal) for the nerve block and whether it will make a difference in how much opioid the patient will receive during and after surgery. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: ACL Surgery
What is being tested?: ACB within true AC with bupivacaine 0.5% 20cc and ACB proximal to true AC with bupivacaine 0.5% 20cc
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2018to 29 Jun 2021
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients undergoing unilateral, ACL surgery with allograft.
Patients who consent to be randomized.
Patients must be English proficient.

Who cannot join

Patients younger than 18 or older than 75 years of age;
Patients with a history of chronic pain or who are taking medications intended to treat chronic pain such as strong opioids;
Patients with history of neurologic disorder that can interfere with pain sensation;
Patients with a history of drug or alcohol abuse;
Patients who are unable to understand or follow instructions;
Patients with an allergy or a contraindication to any of the medications used in the study, or patients with a contraindication to any of the study procedures;

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Patients with severe liver disease, renal insufficiency, congestive heart failure, and/ or significant heart disease;
Patients with a BMI over 42;
Any patient that the investigators feel cannot comply with all study related procedures.
Patients who do not tolerate Percocet.

Trial locations and contacts

1 site in 1 country.

United States1 site

New York University School of Medicine
New York, New York, 10016

Other trials in United States

About this study

Their will be two randomized groups: 1. ACB within true AC with bupivacaine 0.5% 20cc2. ACB proximal to true AC with bupivacaine 0.5% 20cc

Conditions: ACL Surgery
Being tested: ACB within true AC with bupivacaine 0.5% 20cc, ACB proximal to true AC with bupivacaine 0.5% 20cc

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACB within true AC with bupivacaine 0.5% 20ccDrug
Also called bupivacaine
The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.
ACB proximal to true AC with bupivacaine 0.5% 20ccDrug
Also called bupivacaine
Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine

Study groups in NCT03401450
Study group	Role	What they receive
ACB within true AC with bupivacaine	Active comparator	The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine Receives: Drug: ACB within true AC with bupivacaine 0.5% 20cc
ACB proximal to true AC with bupivacaine	Active comparator	The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine Receives: Drug: ACB proximal to true AC with bupivacaine 0.5% 20cc

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents
Amount of morphine equivalents administered intraoperatively in 24 hours
Measured: 24 Hours
Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents
Amount of morphine equivalents administered postoperatively in 24 hours
Measured: 24 Hours
Side Effects Such as Nausea, Itching, Constipation.
Measured: 24 hours

Secondary outcomes (1)

Motor Block (Muscle Weakness): in PACU and Measured in Surgeons' Clinic at 3, 6 and 12 Months.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201829 Jun 2021

First posted17 Jan 2018
Study start1 Feb 2018
Primary completion25 Jan 2019
Study completion29 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ACL SurgeryStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03401450
Sponsor's protocol ID: 17-01602
Status last verified: Jun 2023
First submitted: 10 Jan 2018
Last updated: 14 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All ACL Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimal Location of Nerve Block to Minimize Perioperative Opioid Administration in ACL Surgery: Comparing True Adductor Canal to Proximal Block
ClinicalTrials.gov ID: NCT03401450
Acronym / sponsor ID: 17-01602
Conditions: ACL Surgery
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Study start: 1 Feb 2018 (actual)
Primary completion: 25 Jan 2019 (actual)
Study completion: 29 Jun 2021 (actual)
First posted: 17 Jan 2018 (actual)
Results: Posted 23 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Their will be two randomized groups: 1. ACB within true AC with bupivacaine 0.5% 20cc2. ACB proximal to true AC with bupivacaine 0.5% 20cc

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
ACB within true AC with bupivacaine	Active comparator	Drug: ACB within true AC with bupivacaine 0.5% 20ccThe patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine
ACB proximal to true AC with bupivacaine	Active comparator	Drug: ACB proximal to true AC with bupivacaine 0.5% 20ccThe patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients undergoing unilateral, ACL surgery with allograft.
Patients who consent to be randomized.
Patients must be English proficient.

Key exclusion criteria (10 listed)

Patients younger than 18 or older than 75 years of age;
Patients with a history of chronic pain or who are taking medications intended to treat chronic pain such as strong opioids;
Patients with history of neurologic disorder that can interfere with pain sensation;
Patients with a history of drug or alcohol abuse;
Patients who are unable to understand or follow instructions;

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
ACB within true AC with bupivacaine 0.5% 20ccAlso: bupivacaineThe adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.	Drug	ACB within true AC with bupivacaine
ACB proximal to true AC with bupivacaine 0.5% 20ccAlso: bupivacainePatients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine	Drug	ACB proximal to true AC with bupivacaine

Primary outcome

Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents
Time frame: 24 Hours
Amount of morphine equivalents administered intraoperatively in 24 hours
Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents
Time frame: 24 Hours
Amount of morphine equivalents administered postoperatively in 24 hours
Side Effects Such as Nausea, Itching, Constipation.
Time frame: 24 hours

1 secondary outcome

Motor Block (Muscle Weakness): in PACU and Measured in Surgeons' Clinic at 3, 6 and 12 Months.
Time frame: 12 months

Results and safety

Results posted to the registry on 23 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ACB Within True AC With Bupivacaine	33	21
ACB Proximal to True AC With Bupivacaine	36	23

Primary outcome: Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents

Time frame: 24 Hours. Mean (Standard Deviation). Unit: milligrams of morphine equivalents

Measure	ACB Within True AC With Bupivacaine n = 21	ACB Proximal to True AC With Bupivacaine n = 23
Value	23.21 (12.23)	18.93 (9.34)

Primary outcome: Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents

Time frame: 24 Hours. Mean (Standard Deviation). Unit: mg of morphine equivalents

Measure	ACB Within True AC With Bupivacaine n = 21	ACB Proximal to True AC With Bupivacaine n = 23
Value	10 (6.79)	13.18 (7.57)

Primary outcome: Side Effects Such as Nausea, Itching, Constipation.

Time frame: 24 hours. Count of participants. Unit: Participants

Measure	ACB Within True AC With Bupivacaine n = 21	ACB Proximal to True AC With Bupivacaine n = 23
Value	0	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACB Within True AC With Bupivacaine	0 of 20 (0%)	0 of 20 (0%)	0 of 20
ACB Proximal to True AC With Bupivacaine	0 of 23 (0%)	0 of 23 (0%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for ACL Surgery

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Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
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Recruiting
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Recruiting
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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.

Prianka Desai, MD principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 10 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: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents (time frame: 24 Hours). The study lists 3 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 NCT03401450.

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 14 Jul 2023.