Trial Outcomes & Findings for Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following ACL Reconstruction With Bone Patellar Tendon Bone Autograft: (NCT NCT05286307)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

102 participants

Primary outcome timeframe

Up to Hour 24 Post-Operation

Results posted on

2024-04-26

Participant Flow

Participant milestones

Participant milestones
Measure	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	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%).
Overall Study STARTED	52	50
Overall Study COMPLETED	24	12
Overall Study NOT COMPLETED	28	38

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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%).
Overall Study Incomplete outcome assessments	2	1
Overall Study Discovery of multi-ligamentous injury intra-operatively	0	1
Overall Study Lost to follow up at 6 months	25	35
Overall Study Study medication not available	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Receiving IPACK Block n=24 Participants 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	Standard of Care Group n=12 Participants Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%).	Total n=36 Participants Total of all reporting groups
Age, Continuous	27.88 years STANDARD_DEVIATION 7.42 • n=5 Participants	29.67 years STANDARD_DEVIATION 10.38 • n=7 Participants	28.47 years STANDARD_DEVIATION 8.41 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	4 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	10 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	12 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Hour 24 Post-Operation

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

Outcome measures

Outcome measures
Measure	Participants Receiving IPACK Block n=49 Participants 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	Standard of Care Group n=47 Participants Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%).
Opioid Utilization in First 24 Hours Post-Surgery	6.1 morphine milligram equivalents Standard Deviation 5.5	10.7 morphine milligram equivalents Standard Deviation 7.1

SECONDARY outcome

Timeframe: Hour 24 Post-Operation

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.

Outcome measures

Outcome measures
Measure	Participants Receiving IPACK Block n=49 Participants 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	Standard of Care Group n=47 Participants Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%).
Patient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery	55.2 score on a scale Standard Deviation 18.8	67.7 score on a scale Standard Deviation 26.3

SECONDARY outcome

Timeframe: Hour 48 Post-Operation

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.

Outcome measures

Outcome measures
Measure	Participants Receiving IPACK Block n=49 Participants 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	Standard of Care Group n=46 Participants Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%).
Patient-Reported VAS Scores at 48 Hours Post-Surgery	55.5 score on a scale Standard Deviation 24.34	64 score on a scale Standard Deviation 22.6

SECONDARY outcome

Timeframe: Hour 72 Post-Operation

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.

Outcome measures

Outcome measures
Measure	Participants Receiving IPACK Block n=49 Participants 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	Standard of Care Group n=45 Participants Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%).
Patient-Reported VAS Scores at 72 Hours Post-Surgery	44.4 score on a scale Standard Deviation 23.83	54.9 score on a scale Standard Deviation 24.18

SECONDARY outcome

Timeframe: Day 7 Post-Operation

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.

Outcome measures

Outcome measures
Measure	Participants Receiving IPACK Block n=46 Participants 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	Standard of Care Group n=43 Participants Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%).
Patient-Reported VAS Scores at Day 7 Post-Surgery	36.3 score on a scale Standard Deviation 23.02	42 score on a scale Standard Deviation 24.17

SECONDARY outcome

Timeframe: Up to Day 1 Post-Operation

Measured by the length of stay after surgery (minutes)

Outcome measures

Outcome measures
Measure	Participants Receiving IPACK Block n=49 Participants 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	Standard of Care Group n=47 Participants Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%).
Length of Stay in Post-Anesthesia Care Unit (PACU)	131.19 Minutes Standard Deviation 50.47	131.22 Minutes Standard Deviation 37.5

SECONDARY outcome

Timeframe: Baseline, Month 6 Post-Operation Visit

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.

Outcome measures

Outcome measures
Measure	Participants Receiving IPACK Block n=24 Participants 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	Standard of Care Group n=12 Participants Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%).
Change in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS)	4.88 score on a scale Standard Deviation 13.6	13.52 score on a scale Standard Deviation 14.58

SECONDARY outcome

Timeframe: Baseline, Month 6 Post-Operation Visit

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.

Outcome measures

Outcome measures
Measure	Participants Receiving IPACK Block n=24 Participants 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	Standard of Care Group n=12 Participants Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%).
Change in Kujala Scale Score	9.47 score on a scale Standard Deviation 14.86	18.75 score on a scale Standard Deviation 19.75

SECONDARY outcome

Timeframe: Baseline, Month 6 Post-Operation Visit

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.

Outcome measures

Outcome measures
Measure	Participants Receiving IPACK Block n=24 Participants 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	Standard of Care Group n=12 Participants Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%).
Change in Tegner Activity Scale (TAS) Score	1.25 score on a scale Standard Deviation 1.11	1.92 score on a scale Standard Deviation 1.83

SECONDARY outcome

Timeframe: Baseline, Month 6 Post-Operation Visit

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

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.

Outcome measures

Outcome data not reported

Adverse Events

Participants Receiving IPACK Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eric J Strauss, MD

NYU Langone Health

Phone: 646 501-7223

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place