Trial Outcomes & Findings for The Analgesic Efficacy of Protocol for Primary Total Knee Arthroplasty (TKA) (NCT NCT03703206)

Results Overview

Each patient will be provided by a colored chart that will have different parts of the knee marked clearly and they will indicate whether the pain they have in which region of the knee. the different regions are ( anterior, posterior, lateral, medial, and the middle of the thigh). it will be marked as a yes or no question. it will be measured as a ratio of patients in each patient who has the pain in the numerator and all patients in the study will be in the denominator

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

120 participants

Primary outcome timeframe

Six hours after surgery

Results posted on

2024-05-30

Participant Flow

Four hundred and sixty-four patients were screened for eligibility, with 120 patients ultimately enrolling in the study. Of the 120 patients enrolled, 119 patients completed all necessary follow-up for inclusion into the study

120 patients enrolled, 119 patients completed all necessary follow-up for inclusion in the study: 60 patients in the IPACK group and 59 patients in the sham group. There were no block failures. These 119 patients were randomized to receive either an IPACK or a sham block in addition to multimodal analgesia and an ACB. We were set to assess pain in the back of the knee 6 hours after surgery, quality of recovery after surgery, pain scores, opioid requirements, and functional measures

Participant milestones

Participant milestones
Measure	ACB + iPACK Patients scheduled for TKA will be randomized to receive an adductor canal block with an additional ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK). Ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK): nerve block for posterior knee pain after a TKA.	ACB w/o iPACK Patients enrolled in this arm will receive the standard of care adductor canal block (ACB) prior to their total knee arthoplasty.
Overall Study STARTED	60	59
Overall Study COMPLETED	60	59
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Analgesic Efficacy of Protocol for Primary Total Knee Arthroplasty (TKA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ACB + iPACK n=60 Participants Patients scheduled for TKA will be randomized to receive an adductor canal block with an additional ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK). Ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK): nerve block for posterior knee pain after a TKA.	ACB w/o iPACK n=59 Participants Patients enrolled in this arm will receive the standard of care adductor canal block (ACB) prior to their total knee arthoplasty.	Total n=119 Participants Total of all reporting groups
Age, Continuous	67.7 Age (years) STANDARD_DEVIATION 7.8 • n=5 Participants	65.6 Age (years) STANDARD_DEVIATION 8.2 • n=7 Participants	66.7 Age (years) STANDARD_DEVIATION 8.03 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	35 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Race/Ethnicity, Customized White	45 Participants n=5 Participants	38 Participants n=7 Participants	83 Participants n=5 Participants
Race/Ethnicity, Customized African American	14 Participants n=5 Participants	20 Participants n=7 Participants	34 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Six hours after surgery

Each patient will be provided by a colored chart that will have different parts of the knee marked clearly and they will indicate whether the pain they have in which region of the knee. the different regions are ( anterior, posterior, lateral, medial, and the middle of the thigh). it will be marked as a yes or no question. it will be measured as a ratio of patients in each patient who has the pain in the numerator and all patients in the study will be in the denominator

Outcome measures

Outcome measures
Measure	ACB + iPACK n=60 Participants Patients scheduled for TKA will be randomized to receive an adductor canal block with an additional ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK). Ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK): nerve block for posterior knee pain after a TKA.	ACB w/o iPACK n=59 Participants Patients enrolled in this arm will receive the standard of care adductor canal block (ACB) prior to their total knee arthoplasty.
Percentage of Patients Presenting With Pain in the Back of the Knee 6 Hours After Surgery	21.7 percentage of patients reporting pain	45.8 percentage of patients reporting pain

SECONDARY outcome

Timeframe: 24 hours after surgery

Average of pain scores over the first 24 hours following the regional anesthetic based on Numeric Rating Scale ( NRS). The scale is from 0 - 10, where 0 is no pain and 10 is the worst pain possible.

Outcome measures

Outcome measures
Measure	ACB + iPACK n=60 Participants Patients scheduled for TKA will be randomized to receive an adductor canal block with an additional ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK). Ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK): nerve block for posterior knee pain after a TKA.	ACB w/o iPACK n=59 Participants Patients enrolled in this arm will receive the standard of care adductor canal block (ACB) prior to their total knee arthoplasty.
Pain Score Measurement Reported by Patients	5 pain scores Standard Deviation 0.01	6 pain scores Standard Deviation 0.01

SECONDARY outcome

Timeframe: one week, measurements are obtained at 24 hours, 48 hours, and one week

Score of QoR-15 survey to determine recovery status. The questionnaire is a 15 item questionnaire and each question has a score possible from 0-10. It has two parts. Part 1 includes questions from 1-10. the scale on this question ranges from 0=none of the time ( poor) to 10=all the time ( excellent). The 2nd part include questions from 11-15 where the scale goes from 10 to 0, where 10=none of the time ( excellent) and 0=all the time (poor). The total score is obtained by adding the scores of all the 15 questions. The total score is 0 (poor\_ to 150 (excellent).

Outcome measures

Outcome measures
Measure	ACB + iPACK n=60 Participants Patients scheduled for TKA will be randomized to receive an adductor canal block with an additional ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK). Ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK): nerve block for posterior knee pain after a TKA.	ACB w/o iPACK n=59 Participants Patients enrolled in this arm will receive the standard of care adductor canal block (ACB) prior to their total knee arthoplasty.
Quality of Recovery (QoR) Score Postoperative Day 1	113 score on a scale Standard Deviation 0.66	114 score on a scale Standard Deviation 0.66
Quality of Recovery (QoR) Score Postoperative Day 2	118 score on a scale Standard Deviation 0.37	123 score on a scale Standard Deviation 0.37
Quality of Recovery (QoR) Score Postoperative Day 7	131 score on a scale Standard Deviation 0.11	126 score on a scale Standard Deviation 0.11

Adverse Events

ACB + iPACK

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ACB w/o iPACK

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

Nabil Elkassbany, MD

University of Pennsylvania

Phone: 2158236700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place