Trial Outcomes & Findings for Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI) (NCT NCT03094663)

NCT ID: NCT03094663

Last Updated: 2024-12-27

Results Overview

Numeric Rating Scale (NRS) Pain scores with ambulation 24 hours post block administration. Min = 0, no pain Max = 10, worst imaginable pain

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 86 participants
• Primary outcome timeframe: 24 hours post block administration
• Results posted on: 2024-12-27

Participant Flow

Participant milestones

Measure	Peri-Articular Injections Only Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone. Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine 2 mg IV dexamethasone.: 2 mg IV dexamethasone. bupivacaine 0.5% with epinephrine 30cc: bupivacaine 0.5% with epinephrine 30cc	Peri-Articular Injections, Adductor Canal Block, and IPACK Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation a. bupivacaine 0.25% with epinephrine 30cc; b. methylprednisolone, 40 mg/ml, 1 ml c. cefazolin, 500 mg in 10 ml d. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation) a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) 1. 25 cc 0.25% bupivacaine Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone: 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine
Overall Study STARTED	43	43
Overall Study COMPLETED	43	43
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI)

Baseline characteristics by cohort

Measure	Peri-Articular Injections Only n=43 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone. Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine 2 mg IV dexamethasone.: 2 mg IV dexamethasone. bupivacaine 0.5% with epinephrine 30cc: bupivacaine 0.5% with epinephrine 30cc	Peri-Articular Injections, Adductor Canal Block, and IPACK n=43 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation a. bupivacaine 0.25% with epinephrine 30cc; b. methylprednisolone, 40 mg/ml, 1 ml c. cefazolin, 500 mg in 10 ml d. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation) a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) 1. 25 cc 0.25% bupivacaine Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone: 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine	Total n=86 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Age, Continuous	67.1 years STANDARD_DEVIATION 8.1 • n=5 Participants	68.3 years STANDARD_DEVIATION 7 • n=7 Participants	67.7 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	23 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	20 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants	39 Participants n=7 Participants	81 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants	43 participants n=7 Participants	86 participants n=5 Participants
Height	167.6 cm STANDARD_DEVIATION 10.5 • n=5 Participants	168.2 cm STANDARD_DEVIATION 9.5 • n=7 Participants	167.9 cm STANDARD_DEVIATION 9.9 • n=5 Participants
Weight	84.3 kg STANDARD_DEVIATION 17.1 • n=5 Participants	80.4 kg STANDARD_DEVIATION 15.9 • n=7 Participants	82.4 kg STANDARD_DEVIATION 16.5 • n=5 Participants
BMI	29.9 kg/m^2 STANDARD_DEVIATION 4.8 • n=5 Participants	28.3 kg/m^2 STANDARD_DEVIATION 4.1 • n=7 Participants	29.1 kg/m^2 STANDARD_DEVIATION 4.5 • n=5 Participants
ASA status ASA I	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
ASA status ASA II	41 Participants n=5 Participants	40 Participants n=7 Participants	81 Participants n=5 Participants
ASA status ASA III	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours post block administration

Numeric Rating Scale (NRS) Pain scores with ambulation 24 hours post block administration.

Min = 0, no pain Max = 10, worst imaginable pain

Outcome measures

Measure	Peri-Articular Injections Only n=43 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone. Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine 2 mg IV dexamethasone.: 2 mg IV dexamethasone. bupivacaine 0.5% with epinephrine 30cc: bupivacaine 0.5% with epinephrine 30cc	Peri-Articular Injections, Adductor Canal Block, and IPACK n=43 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation a. bupivacaine 0.25% with epinephrine 30cc; b. methylprednisolone, 40 mg/ml, 1 ml c. cefazolin, 500 mg in 10 ml d. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation) a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) 1. 25 cc 0.25% bupivacaine Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone: 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine
Numeric Rating Scale (NRS) Pain Scores	5.0 score on a scale Standard Deviation 1.7	1.7 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3

Opioid consumption at different intervals. Although collected at different time points, the average amount of opioid across all the time points was calculated and reported.

Outcome measures

Measure	Peri-Articular Injections Only n=43 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone. Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine 2 mg IV dexamethasone.: 2 mg IV dexamethasone. bupivacaine 0.5% with epinephrine 30cc: bupivacaine 0.5% with epinephrine 30cc	Peri-Articular Injections, Adductor Canal Block, and IPACK n=43 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation a. bupivacaine 0.25% with epinephrine 30cc; b. methylprednisolone, 40 mg/ml, 1 ml c. cefazolin, 500 mg in 10 ml d. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation) a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) 1. 25 cc 0.25% bupivacaine Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone: 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine
Opioid Consumption	69.1 oral morphine equivalents (mg) Standard Deviation 79.9	40.6 oral morphine equivalents (mg) Standard Deviation 32.1

SECONDARY outcome

Timeframe: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3

Numeric Rating Scale (NRS) Pain scores at rest and with movement at different intervals Min = 0, no pain Max = 10, worst imaginable pain

Despite being collected at various times, the average pain score across all time points was calculated and reported.

Outcome measures

Measure	Peri-Articular Injections Only n=43 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone. Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine 2 mg IV dexamethasone.: 2 mg IV dexamethasone. bupivacaine 0.5% with epinephrine 30cc: bupivacaine 0.5% with epinephrine 30cc	Peri-Articular Injections, Adductor Canal Block, and IPACK n=43 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation a. bupivacaine 0.25% with epinephrine 30cc; b. methylprednisolone, 40 mg/ml, 1 ml c. cefazolin, 500 mg in 10 ml d. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation) a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) 1. 25 cc 0.25% bupivacaine Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone: 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine
Numeric Rating Scale (NRS) Pain Scores at Rest and With Movement	3.4 score on a scale Standard Deviation 2.1	1.2 score on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: It will be assessed on 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3

Population: some patients were discharged or unable to ambulate during time point.

The distance patients were able to walked during physical therapy ambulation. Measured in feet.

The average distance that patients walked at each time point was calculated and reported for the number of participants analyzed.

Outcome measures

Measure	Peri-Articular Injections Only n=43 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone. Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine 2 mg IV dexamethasone.: 2 mg IV dexamethasone. bupivacaine 0.5% with epinephrine 30cc: bupivacaine 0.5% with epinephrine 30cc	Peri-Articular Injections, Adductor Canal Block, and IPACK n=43 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation a. bupivacaine 0.25% with epinephrine 30cc; b. methylprednisolone, 40 mg/ml, 1 ml c. cefazolin, 500 mg in 10 ml d. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation) a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) 1. 25 cc 0.25% bupivacaine Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone: 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine
Ambulation Distance During Physical Therapy Post-operative day 2, 48 hours	112 feet Standard Deviation 38.7	116.7 feet Standard Deviation 51.7
Ambulation Distance During Physical Therapy Post-operative day 0, <24 hours	23.2 feet Standard Deviation 26.1	25.7 feet Standard Deviation 28.8
Ambulation Distance During Physical Therapy Post-operative day 1, 24 hours	81.1 feet Standard Deviation 61	87.7 feet Standard Deviation 46.2
Ambulation Distance During Physical Therapy Post-operative day 3, 72 hours	106.5 feet Standard Deviation 51.8	119.5 feet Standard Deviation 59.9

SECONDARY outcome

Timeframe: Post-Operative Day 2

Population: Because patients were not reachable for follow-up on post-operative day 2, the total number of participants analyzed for this outcome was reduced.

Patient satisfaction with their postoperative pain management. Measured on a scale of 0 to 10, with 0 meaning extremely dissatisfied and 10 meaning extremely satisfied.

Outcome measures

Measure	Peri-Articular Injections Only n=36 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone. Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine 2 mg IV dexamethasone.: 2 mg IV dexamethasone. bupivacaine 0.5% with epinephrine 30cc: bupivacaine 0.5% with epinephrine 30cc	Peri-Articular Injections, Adductor Canal Block, and IPACK n=33 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation a. bupivacaine 0.25% with epinephrine 30cc; b. methylprednisolone, 40 mg/ml, 1 ml c. cefazolin, 500 mg in 10 ml d. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation) a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) 1. 25 cc 0.25% bupivacaine Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone: 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine
Level of Patient Satisfaction With Postoperative Pain Management	8.8 score on a scale Standard Deviation 1.3	9.5 score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Post-Operative Day 1 and Post-Operative Day 2, average across the two time points reported

Population: Because patients were not reachable for follow-up on post-operative day 2, the total number of participants analyzed for this outcome was reduced.

The Pain Outcomes (PainOUT) questionnaire was used to assess postoperative pain, psychological variables associated with pain, opioid consumption, satisfaction, and side effects. Scored on 3 scales of 0 to 10, depending on each individual question:

0 = no pain, 10 = worst pain imaginable 0 = did not interfere, 10 = completely interfered 0 = not at all, 10 = extremely

Although measured across different timepoints, the average score of all participants was calculated and reported.

Outcome measures

Measure	Peri-Articular Injections Only n=36 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone. Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine 2 mg IV dexamethasone.: 2 mg IV dexamethasone. bupivacaine 0.5% with epinephrine 30cc: bupivacaine 0.5% with epinephrine 30cc	Peri-Articular Injections, Adductor Canal Block, and IPACK n=33 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation a. bupivacaine 0.25% with epinephrine 30cc; b. methylprednisolone, 40 mg/ml, 1 ml c. cefazolin, 500 mg in 10 ml d. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation) a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) 1. 25 cc 0.25% bupivacaine Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone: 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine
Pain Outcomes	6.9 score on a scale Standard Deviation 2.1	5.6 score on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: Assessed at either: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, or 72 hours on Post-Operative Day 3

The patients' Length of Stay (LOS) at the hospital will be calculate with the time the patient entered the post-operative care unit being the "begin time" and the time patient was discharged being the "end time." The "end time" will differ for each patient depending on which day (post-operative day 1, post-operative day 2, or post-operative day 3) they were discharged.

The average length of stay for all patients (reported in minutes) will be reported.

Outcome measures

Measure	Peri-Articular Injections Only n=43 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone. Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine 2 mg IV dexamethasone.: 2 mg IV dexamethasone. bupivacaine 0.5% with epinephrine 30cc: bupivacaine 0.5% with epinephrine 30cc	Peri-Articular Injections, Adductor Canal Block, and IPACK n=43 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation a. bupivacaine 0.25% with epinephrine 30cc; b. methylprednisolone, 40 mg/ml, 1 ml c. cefazolin, 500 mg in 10 ml d. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation) a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) 1. 25 cc 0.25% bupivacaine Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone: 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine
Hospital Length of Stay	2991 minutes Interval 2874.0 to 4289.0	3081 minutes Interval 2833.0 to 4182.0

SECONDARY outcome

Timeframe: Post-Operative Day 1 and Post-Operative Day 2

Population: some patients did not answer questionnaire.

ORSDS scores. A lower score is a better outcome. range is 0 to 4.

Outcome measures

Measure	Peri-Articular Injections Only n=43 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone. Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine 2 mg IV dexamethasone.: 2 mg IV dexamethasone. bupivacaine 0.5% with epinephrine 30cc: bupivacaine 0.5% with epinephrine 30cc	Peri-Articular Injections, Adductor Canal Block, and IPACK n=43 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation a. bupivacaine 0.25% with epinephrine 30cc; b. methylprednisolone, 40 mg/ml, 1 ml c. cefazolin, 500 mg in 10 ml d. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation) a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) 1. 25 cc 0.25% bupivacaine Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone: 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine
Opioid Related Symptom Distress Scale (ORSDS) Post-operative day 1, 24 hrs	0.4 score on a scale Standard Deviation 0.3	0.3 score on a scale Standard Deviation 0.3
Opioid Related Symptom Distress Scale (ORSDS) Post-operative day 2, 48 hrs	0.5 score on a scale Standard Deviation 0.4	0.4 score on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: Measured at pre-operation (day of surgery) and 6 weeks post-operation

Population: Because patients were not reachable for follow-up at 6 weeks post-surgery, the total number of participants analyzed for this outcome was reduced.

This is a patient-reported joint-specific score used to assess outcomes following total knee arthroplasty. Scores range from 0 to 100, with 0 representing total knee disability and 100 representing perfect knee health. Higher score means better outcome.

The average score for each time point is reported for each arm.

Outcome measures

Measure	Peri-Articular Injections Only n=43 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation 1. bupivacaine 0.5% with epinephrine 30cc; 2. methylprednisolone, 40 mg/ml, 1 ml 3. cefazolin, 500 mg in 10 ml 4. normal saline, 22cc 2. Superficial injection prior to closure. 1. 20cc 0.25% bupivacaine 2. 2 mg IV dexamethasone. Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine 2 mg IV dexamethasone.: 2 mg IV dexamethasone. bupivacaine 0.5% with epinephrine 30cc: bupivacaine 0.5% with epinephrine 30cc	Peri-Articular Injections, Adductor Canal Block, and IPACK n=43 Participants Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) 1. Injection prior to cementation a. bupivacaine 0.25% with epinephrine 30cc; b. methylprednisolone, 40 mg/ml, 1 ml c. cefazolin, 500 mg in 10 ml d. normal saline, 22cc 2. Superficial injection prior to closure. a. 20cc 0.25% bupivacaine 3. Adductor canal block technique (supine position, post IV sedation) a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 4. IPACK technique (supine position) 1. 25 cc 0.25% bupivacaine Bupivacaine: 0.5% with epinephrine 30cc Methylprednisolone: 40 mg/ml, 1 ml Cefazolin: 500 mg in 10 ml 8 MHz. Chiba needle: 22G/ 4 inches 15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone: 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone 25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine 20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Pre-operation	54 score on a scale Standard Deviation 9	52 score on a scale Standard Deviation 10
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) 6 weeks post surgery	73 score on a scale Standard Deviation 11	77 score on a scale Standard Deviation 13

Adverse Events

Peri-Articular Injections Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Peri-Articular Injections, Adductor Canal Block, and 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

Dr. David Kim

Hospital for Special Surgery, Anesthesiology

Phone: 2126061036

Email: kimd@hss.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place