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Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following ACL Reconstruction With Bone Patellar Tendon Bone Autograft:

Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following ACL Reconstruction With Bone Patellar Tendon Bone Autograft: A Single Center Randomized Placebo-Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05286307
Enrollment
102
Registered
2022-03-18
Start date
2022-07-11
Completion date
2023-12-18
Last updated
2024-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Rupture

Brief summary

A randomized, single-blind, single-center study measuring the effects of adductor canal block combined with IPACK infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing ACL reconstruction with Bone Patellar Tendon Bone Autograft

Detailed description

The protocol will determine if the addition of an IPACK block to the standard adductor canal block is superior to an isolated adductor canal block in controlling post-operative pain and decreasing postoperative opioid consumption in patients undergoing ACLR with Bone Patellar Tendon Bone Autograft

Interventions

IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients between 18 and 75 years of age * Patients undergoing primary ACL reconstruction with BPTB Autograft * ASA I or II

Exclusion criteria

* Patients younger than 18 and older than 75. * Patients with multi-ligament injury * Patients undergoing concomitant cartilage procedure or osteotomy. * Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer. * Patients who are allergic to oxycodone; * Patients with diagnosed or self-reported cognitive dysfunction; * Patients with a history of neurologic disorder that can interfere with pain sensation; * Patients with a history of drug or recorded alcohol abuse; * Patients who are unable to understand or follow instructions; * Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease; * Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures; * Patients with a BMI over 45; * Any patient that the investigators feel cannot comply with all study related procedures; * Any pregnant patient; assessed via urine pregnancy test in the preoperative area as part of standard preoperative surgical protocol;

Design outcomes

Primary

MeasureTime frameDescription
Opioid Utilization in First 24 Hours Post-SurgeryUp to Hour 24 Post-OperationOpioid utilization for the first 24 hours after surgery, including during surgery, is calculated as oral morphine equivalent.

Secondary

MeasureTime frameDescription
Patient-Reported VAS Scores at 48 Hours Post-SurgeryHour 48 Post-OperationVAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.
Patient-Reported VAS Scores at 72 Hours Post-SurgeryHour 72 Post-OperationVAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.
Patient-Reported VAS Scores at Day 7 Post-SurgeryDay 7 Post-OperationVAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.
Length of Stay in Post-Anesthesia Care Unit (PACU)Up to Day 1 Post-OperationMeasured by the length of stay after surgery (minutes)
Patient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-SurgeryHour 24 Post-OperationVAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score ranges from 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.
Change in Kujala Scale ScoreBaseline, Month 6 Post-Operation VisitKnee pain will be measured by self reported Kujala scale. The Kujala Scale is a 13-item screening instrument designed to assess patellofemoral pain in adolescents and young adults, with a variable ordinal response format. For example, a 'Limp' score would be scored as follows: none (5), slight/periodic (3), constant (0). The total score ranges from 0 to 100; higher scores indicate lesser knee pain.
Change in Tegner Activity Scale (TAS) ScoreBaseline, Month 6 Post-Operation VisitThe TAS asks participants to indicate the highest level of activity they are able to participate in at the time of the survey. The options range from Level 10 (competitive sports on a national elite level) to Level 0 (sick leave or disability pension because of knee problems). The total score corresponds with the selected Level and ranges from 0-10; higher scores indicate higher levels of activity.
Change of Range of Motion (ROM) AssessmentBaseline, Month 6 Post-Operation VisitA Range of Motion (ROM) assessment is most commonly used to measure movement of the ankles, knees, hips, shoulders, elbows, wrists and fingers. Measures of knee ROM will be taken at baseline and Month 6 to assess the change in ROM over time.
Change in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS)Baseline, Month 6 Post-Operation VisitThe KOOS-PS is a 7-item measure of physical functional derived from the items of the Function, daily living and Function, sports and recreational activity subscales of the KOOS. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. The raw score is calculated by summing the responses and ranges from 0-28. The raw score is converted to a true interval score ranging from 0-100, where higher scores indicate greater physical function.

Countries

United States

Participant flow

Participants by arm

ArmCount
Participants Receiving IPACK Block
Patients in this study group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). And receive the additional IPACK block performed using 20 mL of Bupivacaine (0.25%) injected into the interspace between the popliteal artery and capsule of the knee. IPACK block: IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee
24
Standard of Care Group
Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%).
12
Total36

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDiscovery of multi-ligamentous injury intra-operatively01
Overall StudyIncomplete outcome assessments21
Overall StudyLost to follow up at 6 months2535
Overall StudyStudy medication not available11

Baseline characteristics

CharacteristicParticipants Receiving IPACK BlockTotalStandard of Care Group
Age, Continuous27.88 years
STANDARD_DEVIATION 7.42
28.47 years
STANDARD_DEVIATION 8.41
29.67 years
STANDARD_DEVIATION 10.38
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
24 Participants34 Participants10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
4 Participants6 Participants2 Participants
Race (NIH/OMB)
Black or African American
4 Participants5 Participants1 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants1 Participants
Race (NIH/OMB)
White
14 Participants22 Participants8 Participants
Region of Enrollment
United States
24 participants36 participants12 participants
Sex: Female, Male
Female
11 Participants19 Participants8 Participants
Sex: Female, Male
Male
13 Participants17 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 520 / 50
other
Total, other adverse events
0 / 520 / 50
serious
Total, serious adverse events
0 / 520 / 50

Outcome results

Primary

Opioid Utilization in First 24 Hours Post-Surgery

Opioid utilization for the first 24 hours after surgery, including during surgery, is calculated as oral morphine equivalent.

Time frame: Up to Hour 24 Post-Operation

ArmMeasureValue (MEAN)Dispersion
Participants Receiving IPACK BlockOpioid Utilization in First 24 Hours Post-Surgery6.1 morphine milligram equivalentsStandard Deviation 5.5
Standard of Care GroupOpioid Utilization in First 24 Hours Post-Surgery10.7 morphine milligram equivalentsStandard Deviation 7.1
Secondary

Change in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS)

The KOOS-PS is a 7-item measure of physical functional derived from the items of the Function, daily living and Function, sports and recreational activity subscales of the KOOS. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. The raw score is calculated by summing the responses and ranges from 0-28. The raw score is converted to a true interval score ranging from 0-100, where higher scores indicate greater physical function.

Time frame: Baseline, Month 6 Post-Operation Visit

ArmMeasureValue (MEAN)Dispersion
Participants Receiving IPACK BlockChange in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS)4.88 score on a scaleStandard Deviation 13.6
Standard of Care GroupChange in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS)13.52 score on a scaleStandard Deviation 14.58
Secondary

Change in Kujala Scale Score

Knee pain will be measured by self reported Kujala scale. The Kujala Scale is a 13-item screening instrument designed to assess patellofemoral pain in adolescents and young adults, with a variable ordinal response format. For example, a 'Limp' score would be scored as follows: none (5), slight/periodic (3), constant (0). The total score ranges from 0 to 100; higher scores indicate lesser knee pain.

Time frame: Baseline, Month 6 Post-Operation Visit

ArmMeasureValue (MEAN)Dispersion
Participants Receiving IPACK BlockChange in Kujala Scale Score9.47 score on a scaleStandard Deviation 14.86
Standard of Care GroupChange in Kujala Scale Score18.75 score on a scaleStandard Deviation 19.75
Secondary

Change in Tegner Activity Scale (TAS) Score

The TAS asks participants to indicate the highest level of activity they are able to participate in at the time of the survey. The options range from Level 10 (competitive sports on a national elite level) to Level 0 (sick leave or disability pension because of knee problems). The total score corresponds with the selected Level and ranges from 0-10; higher scores indicate higher levels of activity.

Time frame: Baseline, Month 6 Post-Operation Visit

ArmMeasureValue (MEAN)Dispersion
Participants Receiving IPACK BlockChange in Tegner Activity Scale (TAS) Score1.25 score on a scaleStandard Deviation 1.11
Standard of Care GroupChange in Tegner Activity Scale (TAS) Score1.92 score on a scaleStandard Deviation 1.83
Secondary

Change of Range of Motion (ROM) Assessment

A Range of Motion (ROM) assessment is most commonly used to measure movement of the ankles, knees, hips, shoulders, elbows, wrists and fingers. Measures of knee ROM will be taken at baseline and Month 6 to assess the change in ROM over time.

Time frame: Baseline, Month 6 Post-Operation Visit

Population: No participants had data collected/were analyzed for the purposes of this outcome measure.

Secondary

Length of Stay in Post-Anesthesia Care Unit (PACU)

Measured by the length of stay after surgery (minutes)

Time frame: Up to Day 1 Post-Operation

ArmMeasureValue (MEAN)Dispersion
Participants Receiving IPACK BlockLength of Stay in Post-Anesthesia Care Unit (PACU)131.19 MinutesStandard Deviation 50.47
Standard of Care GroupLength of Stay in Post-Anesthesia Care Unit (PACU)131.22 MinutesStandard Deviation 37.5
Secondary

Patient-Reported VAS Scores at 48 Hours Post-Surgery

VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.

Time frame: Hour 48 Post-Operation

ArmMeasureValue (MEAN)Dispersion
Participants Receiving IPACK BlockPatient-Reported VAS Scores at 48 Hours Post-Surgery55.5 score on a scaleStandard Deviation 24.34
Standard of Care GroupPatient-Reported VAS Scores at 48 Hours Post-Surgery64 score on a scaleStandard Deviation 22.6
Secondary

Patient-Reported VAS Scores at 72 Hours Post-Surgery

VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.

Time frame: Hour 72 Post-Operation

ArmMeasureValue (MEAN)Dispersion
Participants Receiving IPACK BlockPatient-Reported VAS Scores at 72 Hours Post-Surgery44.4 score on a scaleStandard Deviation 23.83
Standard of Care GroupPatient-Reported VAS Scores at 72 Hours Post-Surgery54.9 score on a scaleStandard Deviation 24.18
Secondary

Patient-Reported VAS Scores at Day 7 Post-Surgery

VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.

Time frame: Day 7 Post-Operation

ArmMeasureValue (MEAN)Dispersion
Participants Receiving IPACK BlockPatient-Reported VAS Scores at Day 7 Post-Surgery36.3 score on a scaleStandard Deviation 23.02
Standard of Care GroupPatient-Reported VAS Scores at Day 7 Post-Surgery42 score on a scaleStandard Deviation 24.17
Secondary

Patient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery

VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score ranges from 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.

Time frame: Hour 24 Post-Operation

ArmMeasureValue (MEAN)Dispersion
Participants Receiving IPACK BlockPatient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery55.2 score on a scaleStandard Deviation 18.8
Standard of Care GroupPatient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery67.7 score on a scaleStandard Deviation 26.3

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026