Trial Outcomes & Findings for Block and Periarticular Injection Study (NCT NCT06410612)

Results Overview

pain score 0-10 10 being more pain

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

174 participants

Primary outcome timeframe

at 2 weeks

Results posted on

2026-04-20

Participant Flow

patients are randomized once consented. patients have been withdrawn and not all patients are analyzed due to incomplete data . these patients are not patients that are just prescreened. they actually are enrolled and randomized.

Participant milestones

Participant milestones
Measure	Block and Periarticular Injection regional anesthesia (Adductor canal block +IPACK) and Periarticular injection regional anesthesia and PAI: this is the block portion of the study PAI: this is the no block portion of the study	Periarticular Injectin Alone Periarticular injection alone PAI: this is the no block portion of the study
Overall Study STARTED	90	84
Overall Study COMPLETED	70	70
Overall Study NOT COMPLETED	20	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

some patients did not have complete data and some patients dropped out of the study after randomization.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Block and Periarticular Injection n=70 Participants regional anesthesia (Adductor canal block +IPACK) and Periarticular injection regional anesthesia and PAI: this is the block portion of the study PAI: this is the no block portion of the study	Periarticular Injectin Alone n=70 Participants Periarticular injection alone PAI: this is the no block portion of the study	Total n=140 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=70 Participants • some patients did not have complete data and some patients dropped out of the study after randomization.	0 Participants n=70 Participants • some patients did not have complete data and some patients dropped out of the study after randomization.	0 Participants n=140 Participants • some patients did not have complete data and some patients dropped out of the study after randomization.
Age, Categorical Between 18 and 65 years	33 Participants n=70 Participants • some patients did not have complete data and some patients dropped out of the study after randomization.	30 Participants n=70 Participants • some patients did not have complete data and some patients dropped out of the study after randomization.	63 Participants n=140 Participants • some patients did not have complete data and some patients dropped out of the study after randomization.
Age, Categorical >=65 years	37 Participants n=70 Participants • some patients did not have complete data and some patients dropped out of the study after randomization.	40 Participants n=70 Participants • some patients did not have complete data and some patients dropped out of the study after randomization.	77 Participants n=140 Participants • some patients did not have complete data and some patients dropped out of the study after randomization.
Age, Continuous	64.9 years n=70 Participants • the overall is patients that were originally enrolled but didn't qualify after enrolled.	65.3 years n=70 Participants • the overall is patients that were originally enrolled but didn't qualify after enrolled.	65.1 years n=140 Participants • the overall is patients that were originally enrolled but didn't qualify after enrolled.
Sex: Female, Male Female	35 Participants n=70 Participants • some patients did not have complete data and also withdrew from the study after randomization.	35 Participants n=70 Participants • some patients did not have complete data and also withdrew from the study after randomization.	70 Participants n=140 Participants • some patients did not have complete data and also withdrew from the study after randomization.
Sex: Female, Male Male	35 Participants n=70 Participants • some patients did not have complete data and also withdrew from the study after randomization.	35 Participants n=70 Participants • some patients did not have complete data and also withdrew from the study after randomization.	70 Participants n=140 Participants • some patients did not have complete data and also withdrew from the study after randomization.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: at 2 weeks

pain score 0-10 10 being more pain

Outcome measures

Outcome measures
Measure	Block and Periarticular Injection n=73 Participants regional anesthesia (Adductor canal block +IPACK) and Periarticular injection regional anesthesia and PAI: this is the block portion of the study PAI: this is the no block portion of the study	Periarticular Injectin Alone n=67 Participants Periarticular injection alone PAI: this is the no block portion of the study
Mean Visual Analog Scale (VAS) Pain Score for 2 Weeks Postoperatively	3.41 score on a scale Standard Deviation 2.94	3.27 score on a scale Standard Deviation 2.78

SECONDARY outcome

Timeframe: postop day 2

opioid medications survey Opioids calculated MMEs (morphine milligram equivalents) milligrams of opioids correlates with the morphine equivalents. Morphine equivalents are standard units used to compare the analgesic potency of different opioids to a reference dose of oral morphine. They calculate total daily, safe, and effective doses

Outcome measures

Outcome measures
Measure	Block and Periarticular Injection n=73 Participants regional anesthesia (Adductor canal block +IPACK) and Periarticular injection regional anesthesia and PAI: this is the block portion of the study PAI: this is the no block portion of the study	Periarticular Injectin Alone n=67 Participants Periarticular injection alone PAI: this is the no block portion of the study
Opioid Use	16.75 milligram morphine equivalents/MME Standard Deviation 14.09	12.82 milligram morphine equivalents/MME Standard Deviation 10.02

SECONDARY outcome

Timeframe: 2 weeks postop

step count throught fitbit

Outcome measures

Outcome measures
Measure	Block and Periarticular Injection n=70 Participants regional anesthesia (Adductor canal block +IPACK) and Periarticular injection regional anesthesia and PAI: this is the block portion of the study PAI: this is the no block portion of the study	Periarticular Injectin Alone n=70 Participants Periarticular injection alone PAI: this is the no block portion of the study
Daily Step Count at 2 Weeks Postop	3270.8 steps per day Interval 2838.2 to 3703.4	3352.2 steps per day Interval 2905.6 to 3798.7

SECONDARY outcome

Timeframe: baseline

oxford knee survey through app, 0-48 scale 0 being min and 48 being max score assesses pain and function of the knee Score 0 to 19 May indicate severe knee arthritis requiring surgical intervention. Score 20 to 29 May indicate moderate to severe knee arthritis. Score 30 to 39 May indicate mild to moderate knee arthritis. Score 40 to 48 May indicate satisfactory joint function not requiring treatment.

Outcome measures

Outcome measures
Measure	Block and Periarticular Injection n=70 Participants regional anesthesia (Adductor canal block +IPACK) and Periarticular injection regional anesthesia and PAI: this is the block portion of the study PAI: this is the no block portion of the study	Periarticular Injectin Alone n=70 Participants Periarticular injection alone PAI: this is the no block portion of the study
Oxford Knee Score	26.6 score on a scale Interval 25.1 to 28.1	27.0 score on a scale Interval 25.5 to 28.5

SECONDARY outcome

Timeframe: baseline % of very good sleep and fairly good sleep

sleep quality through app surveys number of participants that answered survey in the app with choices of very good sleep to very bad sleep. 0=very good sleep, 1=fairly good sleep, 2=fairly bad sleep. 3=very bad sleep the outcome measures data table reflects the number or participants that scored 0-1 on the survey at the baseline timepoint.

Outcome measures

Outcome measures
Measure	Block and Periarticular Injection n=72 Participants regional anesthesia (Adductor canal block +IPACK) and Periarticular injection regional anesthesia and PAI: this is the block portion of the study PAI: this is the no block portion of the study	Periarticular Injectin Alone n=64 Participants Periarticular injection alone PAI: this is the no block portion of the study
Sleep Quality Via Survey That Patients Completed Ranging From Very Good Sleep and Fairly Good Sleep	26 Participants	17 Participants

SECONDARY outcome

Timeframe: 7 days postop

oxford knee survey through app, 0-48 scale 0 being min and 48 being max assesses pain and function of the knee Score 0 to 19 May indicate severe knee arthritis requiring surgical intervention. Score 20 to 29 May indicate moderate to severe knee arthritis. Score 30 to 39 May indicate mild to moderate knee arthritis. Score 40 to 48 May indicate satisfactory joint function not requiring treatment.

Outcome measures

Outcome measures
Measure	Block and Periarticular Injection n=70 Participants regional anesthesia (Adductor canal block +IPACK) and Periarticular injection regional anesthesia and PAI: this is the block portion of the study PAI: this is the no block portion of the study	Periarticular Injectin Alone n=70 Participants Periarticular injection alone PAI: this is the no block portion of the study
Oxford Knee Score	21.2 score on a scale Interval 19.7 to 22.7	23.3 score on a scale Interval 21.8 to 24.9

SECONDARY outcome

Timeframe: 14 days postop

oxford knee survey through app, 0-48 scale 0 being min and 48 being max assesses pain and function of the knee Score 0 to 19 May indicate severe knee arthritis requiring surgical intervention. Score 20 to 29 May indicate moderate to severe knee arthritis. Score 30 to 39 May indicate mild to moderate knee arthritis. Score 40 to 48 May indicate satisfactory joint function not requiring treatment.

Outcome measures

Outcome measures
Measure	Block and Periarticular Injection n=70 Participants regional anesthesia (Adductor canal block +IPACK) and Periarticular injection regional anesthesia and PAI: this is the block portion of the study PAI: this is the no block portion of the study	Periarticular Injectin Alone n=70 Participants Periarticular injection alone PAI: this is the no block portion of the study
Oxford Knee Score	25.2 score on a scale Interval 23.7 to 26.7	25.6 score on a scale Interval 24.0 to 27.1

SECONDARY outcome

Timeframe: 7 days postop % of fairly good to very good sleep

sleep quality through app surveys number of participants that answered survey in the app with choices of very good sleep to very bad sleep. 0=very good sleep, 1=fairly good sleep, 2=fairly bad sleep. 3=very bad sleep the outcome measures data table reflects the number or participants that scored 0-1 on the survey at the 7 day timepoint.

Outcome measures

Outcome measures
Measure	Block and Periarticular Injection n=72 Participants regional anesthesia (Adductor canal block +IPACK) and Periarticular injection regional anesthesia and PAI: this is the block portion of the study PAI: this is the no block portion of the study	Periarticular Injectin Alone n=64 Participants Periarticular injection alone PAI: this is the no block portion of the study
Sleep Quality Via App Surveys With Range of Very Good Sleep and Fairly Good Sleep	36 Participants	32 Participants

SECONDARY outcome

Timeframe: 14 days postop % of very good sleep to fairly good sleep

sleep quality through app surveys number of participants that answered survey in the app with choices of very good sleep to very bad sleep. 0=very good sleep, 1=fairly good sleep, 2=fairly bad sleep. 3=very bad sleep the outcome measures data table reflects the number or participants that scored 0-1 on the survey at the 14 day timepoint.

Outcome measures

Outcome measures
Measure	Block and Periarticular Injection n=70 Participants regional anesthesia (Adductor canal block +IPACK) and Periarticular injection regional anesthesia and PAI: this is the block portion of the study PAI: this is the no block portion of the study	Periarticular Injectin Alone n=65 Participants Periarticular injection alone PAI: this is the no block portion of the study
Sleep Quality Via App Surveys With Range of Very Good Sleep to Fairly Good Sleep	41 Participants	30 Participants

Adverse Events

Block and Periarticular Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Periarticular Injection Alone

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

Andrew Schneider

Washington University School of Medicine

Phone: 314-747-2511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place