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CompletedNCT03401450Updated Jul 14, 2023Results posted

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

A Phase 4 interventional study of ACB within true AC with bupivacaine 0.5% 20cc and ACB proximal to true AC with bupivacaine 0.5% 20cc in ACL Surgery, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-14.

Sponsored by NYU Langone Health · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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. Ultrasound will identify the adductor canal and the proximal end of the adductor canal/apex of the femoral triangle to determine the location of the blocks.

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

02

Conditions studied

  • ACL Surgery
03

In context

Lead sponsor

NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.

Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.

Browse NYU Langone Health studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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 to any of the medications used in the study, or patients with a contraindication to any of the study procedures;
  • Patients with severe liver disease, renal insufficiency, congestive heart failure, and/ or significant heart disease;
  • Patients with a over 42;
  • Any patient that the investigators feel cannot comply with all study related procedures.
  • Patients who do not tolerate Percocet.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
69 participants (actual)

Study arms

  • Active comparator
    ACB within true AC with bupivacaine

    The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine

    Drug: ACB within true AC with bupivacaine 0.5% 20cc

  • Active comparator
    ACB proximal to true AC with bupivacaine

    The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine

    Drug: ACB proximal to true AC with bupivacaine 0.5% 20cc

Interventions

  • DrugACB within true AC with bupivacaine 0.5% 20cc

    Drug page: 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.

    Also known as: bupivacaine

  • DrugACB proximal to true AC with bupivacaine 0.5% 20cc

    Drug page: Bupivacaine

    Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine

    Also known as: bupivacaine

06

What researchers measure

Primary outcomes

  1. Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents

    Amount of morphine equivalents administered intraoperatively in 24 hours

    Time frame: 24 Hours

  2. Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents

    Amount of morphine equivalents administered postoperatively in 24 hours

    Time frame: 24 Hours

  3. Side Effects Such as Nausea, Itching, Constipation.

    Time frame: 24 hours

Secondary outcomes

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

    Time frame: 12 months

07

Results

Posted Dec 23, 2020

Participant flow

Participant flow — Overall Study
MilestoneACB Within True AC With BupivacaineACB Proximal to True AC With Bupivacaine
Started3336
Completed2123
Not completed1213
Withdrew: Lost to follow-up46
Withdrew: Anesthesia plan changed22
Withdrew: Did not complete medication diary42
Withdrew: Post surgery medication change21
Withdrew: Cancelled surgery02

Outcome measures

PrimaryTotal Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents

Amount of morphine equivalents administered intraoperatively in 24 hours

Time frame:
24 Hours
Reported as:
Mean · milligrams of morphine equivalents
Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents
milligrams of morphine equivalentsACB Within True AC With BupivacaineACB Proximal to True AC With Bupivacaine
Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents23.21 ± 12.2318.93 ± 9.34
PrimaryTotal Opioid Consumption Postop Measured by Amounts of Morphine Equivalents

Amount of morphine equivalents administered postoperatively in 24 hours

Time frame:
24 Hours
Reported as:
Mean · mg of morphine equivalents
Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents
mg of morphine equivalentsACB Within True AC With BupivacaineACB Proximal to True AC With Bupivacaine
Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents10 ± 6.7913.18 ± 7.57
PrimarySide Effects Such as Nausea, Itching, Constipation.
Time frame:
24 hours
Reported as:
Count of participants · Participants
Side Effects Such as Nausea, Itching, Constipation.
ParticipantsACB Within True AC With BupivacaineACB Proximal to True AC With Bupivacaine
Side Effects Such as Nausea, Itching, Constipation.00
SecondaryMotor Block (Muscle Weakness): in PACU and Measured in Surgeons' Clinic at 3, 6 and 12 Months.
Time frame:
12 months

No measurements were reported for this outcome.

Adverse events

Collected over 24 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ACB Within True AC With Bupivacaine0/20 (0%)0/20 (0%)0/20 (0%)
ACB Proximal to True AC With Bupivacaine0/23 (0%)0/23 (0%)0/23 (0%)

Baseline characteristics

Age, Customized
Age, Customized(Participants)ACB Within True AC With BupivacaineACB Proximal to True AC With BupivacaineTotal
18-25 years10919
26-35 years131528
36-45 years3710
46-55 years6511
56-65 years101
Sex: Female, Male
Sex: Female, Male(Participants)ACB Within True AC With BupivacaineACB Proximal to True AC With BupivacaineTotal
Female141731
Male191938
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ACB Within True AC With BupivacaineACB Proximal to True AC With BupivacaineTotal
American Indian or Alaska Native000
Asian257
Native Hawaiian or Other Pacific Islander000
Black or African American246
White232144
More than one race000
Unknown or Not Reported6612
Region of Enrollment
Region of Enrollment(participants)ACB Within True AC With BupivacaineACB Proximal to True AC With BupivacaineTotal
United States333669
08

Study locations

1 site
  • New York University School of Medicine
    New York, New York 10016, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03401450
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Jan 17, 2018
Start date
Feb 1, 2018
Primary completion
Jan 25, 2019
Completion
Jun 29, 2021
Results posted
Dec 23, 2020
Last update
Jul 14, 2023

Study contacts

Prianka Desai, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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