Knee Arthropathy
Conditions
Keywords
IPACK, PAI
Brief summary
A comparison of two pain control methods - the combination of Adductor Canal Block (ACB)/Periarticular Injection (PAI)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI) - in patients undergoing total knee arthroplasty. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).
Detailed description
Total knee arthroplasties (TKA) are severely painful surgeries that require optimal pain control to ensure expeditious recovery and discharge. Nerve blocks, such as the femoral and sciatic nerves, are instrumental in effectively providing pain relief and improving patient satisfaction. However, though pain scores notably decreased with the introduction of nerve blocks, motor blockade rendered these patients immobile and may pose a fall risk early in the post-operative period. The advent of ultrasound introduces newer block techniques with adequate analgesia without the cost of motor blockade. The adductor canal block serves as an alternative to the femoral or sciatic nerve blocks in providing anterior knee analgesia without significantly compromising quadriceps strength. However, patients' posterior knee compartment remains an issue for pain control. Sciatic and posterior tibial nerve blocks were implemented but again, results in motor blockade. A small percentage of sciatic nerve block cases also exhibit foot drop due to peroneal nerve injury. Alternatively, as a sensory block, the periarticular injection (PAI) proves to hasten ambulation and recovery after TKA. The PAI blind injection into the posterior capsule seems to aid in pain control of the posterior compartment and reduces the total number physical therapy sessions. Injection in the interspace between the Popliteal Artery and Capsule of the posterior Knee (IPACK) provides an alternative to the PAI blind technique for analgesia in the posterior compartment. The IPACK block is not a nerve block, but rather infiltrates the area between the popliteal artery and femur. This area is rich with sensory nerve fibers from the posterior capsule of the knee, which originates from the sciatic and posterior tibial nerve. In this prospective study, we will compare pain scores between the three groups: ACB/PAI/IPACK, ACB/IPACK and PAI only. We will determine whether there is a difference between groups in NRS pain score with ambulation 24 hours post block administration.
Interventions
bupivacaine 0.5% with epinephrine 30cc
DRUGMethylprednisolone
40 mg/ml, 1 ml
DRUGCefazolin
500 mg in 10 ml
DEVICE8 MHz. Chiba needle
22G/ 4 inches
15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone
DRUGBupivacaine 25cc
25 cc 0.25% bupivacaine
DRUGBupivacaine 20cc
20cc 0.25% bupivacaine
DRUGDexamethasone
2 mg IV dexamethasone.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty with a participating surgeon * Age 18 to 80 years * Planned use of regional anesthesia * Ability to follow study protocol * English speaking (secondary outcomes include questionnaires validated in English only) * Patients of participating surgeons
Exclusion criteria
* Hepatic or renal insufficiency * Younger than 18 years old and older than 80 * Patients undergoing general anesthesia * Allergy or intolerance to one of the study medications * BMI \> 40 * Diabetes * ASA of IV * Chronic gabapentin/pregabalin use (regular use for longer than 3 months) * Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of \>5mg/day for one month) * Patients with severe valgus deformity and flexion contracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) Pain Scores | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) Pain Scores at Rest and With Movement | 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. |
| Ambulation Distance During Physical Therapy | 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 | 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. |
| Level of Patient Satisfaction With Postoperative Pain Management | Post-Operative Day 2 | 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. |
| Opioid Consumption | 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. |
| Hospital Length of Stay | 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. |
| Opioid Related Symptom Distress Scale (ORSDS) | Post-Operative Day 1 and Post-Operative Day 2 | ORSDS scores. A lower score is a better outcome. range is 0 to 4. |
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) | Measured at pre-operation (day of surgery) and 6 weeks post-operation | 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. |
| Pain Outcomes | Post-Operative Day 1 and Post-Operative Day 2, average across the two time points reported | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 43 |
| 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 | 43 |
| Total | 86 |
Baseline characteristics
| Characteristic | Peri-Articular Injections Only | Peri-Articular Injections, Adductor Canal Block, and IPACK | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 30 Participants | 32 Participants | 62 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 11 Participants | 24 Participants |
| Age, Continuous | 67.1 years STANDARD_DEVIATION 8.1 | 68.3 years STANDARD_DEVIATION 7 | 67.7 years STANDARD_DEVIATION 7.5 |
| ASA status ASA I | 1 Participants | 0 Participants | 1 Participants |
| ASA status ASA II | 41 Participants | 40 Participants | 81 Participants |
| ASA status ASA III | 1 Participants | 3 Participants | 4 Participants |
| BMI | 29.9 kg/m^2 STANDARD_DEVIATION 4.8 | 28.3 kg/m^2 STANDARD_DEVIATION 4.1 | 29.1 kg/m^2 STANDARD_DEVIATION 4.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 39 Participants | 81 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 167.6 cm STANDARD_DEVIATION 10.5 | 168.2 cm STANDARD_DEVIATION 9.5 | 167.9 cm STANDARD_DEVIATION 9.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 40 Participants | 39 Participants | 79 Participants |
| Region of Enrollment United States | 43 participants | 43 participants | 86 participants |
| Sex: Female, Male Female | 30 Participants | 23 Participants | 53 Participants |
| Sex: Female, Male Male | 13 Participants | 20 Participants | 33 Participants |
| Weight | 84.3 kg STANDARD_DEVIATION 17.1 | 80.4 kg STANDARD_DEVIATION 15.9 | 82.4 kg STANDARD_DEVIATION 16.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 43 |
| other Total, other adverse events | 0 / 43 | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 |
Outcome results
Primary
Numeric Rating Scale (NRS) Pain Scores
Numeric Rating Scale (NRS) Pain scores with ambulation 24 hours post block administration. Min = 0, no pain Max = 10, worst imaginable pain
Time frame: 24 hours post block administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-Articular Injections Only | Numeric Rating Scale (NRS) Pain Scores | 5.0 score on a scale | Standard Deviation 1.7 |
| Peri-Articular Injections, Adductor Canal Block, and IPACK | Numeric Rating Scale (NRS) Pain Scores | 1.7 score on a scale | Standard Deviation 1.4 |
Secondary
Ambulation Distance During Physical Therapy
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peri-Articular Injections Only | Ambulation Distance During Physical Therapy | Post-operative day 0, <24 hours | 23.2 feet | Standard Deviation 26.1 |
| Peri-Articular Injections Only | Ambulation Distance During Physical Therapy | Post-operative day 1, 24 hours | 81.1 feet | Standard Deviation 61 |
| Peri-Articular Injections Only | Ambulation Distance During Physical Therapy | Post-operative day 2, 48 hours | 112 feet | Standard Deviation 38.7 |
| Peri-Articular Injections Only | Ambulation Distance During Physical Therapy | Post-operative day 3, 72 hours | 106.5 feet | Standard Deviation 51.8 |
| Peri-Articular Injections, Adductor Canal Block, and IPACK | Ambulation Distance During Physical Therapy | Post-operative day 3, 72 hours | 119.5 feet | Standard Deviation 59.9 |
| Peri-Articular Injections, Adductor Canal Block, and IPACK | Ambulation Distance During Physical Therapy | Post-operative day 0, <24 hours | 25.7 feet | Standard Deviation 28.8 |
| Peri-Articular Injections, Adductor Canal Block, and IPACK | Ambulation Distance During Physical Therapy | Post-operative day 2, 48 hours | 116.7 feet | Standard Deviation 51.7 |
| Peri-Articular Injections, Adductor Canal Block, and IPACK | Ambulation Distance During Physical Therapy | Post-operative day 1, 24 hours | 87.7 feet | Standard Deviation 46.2 |
Secondary
Hospital Length of Stay
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.
Time frame: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Peri-Articular Injections Only | Hospital Length of Stay | 2991 minutes |
| Peri-Articular Injections, Adductor Canal Block, and IPACK | Hospital Length of Stay | 3081 minutes |
Secondary
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peri-Articular Injections Only | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) | Pre-operation | 54 score on a scale | Standard Deviation 9 |
| Peri-Articular Injections Only | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) | 6 weeks post surgery | 73 score on a scale | Standard Deviation 11 |
| Peri-Articular Injections, Adductor Canal Block, and IPACK | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) | Pre-operation | 52 score on a scale | Standard Deviation 10 |
| Peri-Articular Injections, Adductor Canal Block, and IPACK | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) | 6 weeks post surgery | 77 score on a scale | Standard Deviation 13 |
Secondary
Level of Patient Satisfaction With Postoperative Pain Management
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-Articular Injections Only | Level of Patient Satisfaction With Postoperative Pain Management | 8.8 score on a scale | Standard Deviation 1.3 |
| Peri-Articular Injections, Adductor Canal Block, and IPACK | Level of Patient Satisfaction With Postoperative Pain Management | 9.5 score on a scale | Standard Deviation 1.1 |
Secondary
Numeric Rating Scale (NRS) Pain Scores at Rest and With Movement
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.
Time frame: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-Articular Injections Only | Numeric Rating Scale (NRS) Pain Scores at Rest and With Movement | 3.4 score on a scale | Standard Deviation 2.1 |
| Peri-Articular Injections, Adductor Canal Block, and IPACK | Numeric Rating Scale (NRS) Pain Scores at Rest and With Movement | 1.2 score on a scale | Standard Deviation 1.6 |
Secondary
Opioid Consumption
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.
Time frame: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-Articular Injections Only | Opioid Consumption | 69.1 oral morphine equivalents (mg) | Standard Deviation 79.9 |
| Peri-Articular Injections, Adductor Canal Block, and IPACK | Opioid Consumption | 40.6 oral morphine equivalents (mg) | Standard Deviation 32.1 |
Secondary
Opioid Related Symptom Distress Scale (ORSDS)
ORSDS scores. A lower score is a better outcome. range is 0 to 4.
Time frame: Post-Operative Day 1 and Post-Operative Day 2
Population: some patients did not answer questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peri-Articular Injections Only | Opioid Related Symptom Distress Scale (ORSDS) | Post-operative day 1, 24 hrs | 0.4 score on a scale | Standard Deviation 0.3 |
| Peri-Articular Injections Only | Opioid Related Symptom Distress Scale (ORSDS) | Post-operative day 2, 48 hrs | 0.5 score on a scale | Standard Deviation 0.4 |
| Peri-Articular Injections, Adductor Canal Block, and IPACK | Opioid Related Symptom Distress Scale (ORSDS) | Post-operative day 1, 24 hrs | 0.3 score on a scale | Standard Deviation 0.3 |
| Peri-Articular Injections, Adductor Canal Block, and IPACK | Opioid Related Symptom Distress Scale (ORSDS) | Post-operative day 2, 48 hrs | 0.4 score on a scale | Standard Deviation 0.4 |
Secondary
Pain Outcomes
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-Articular Injections Only | Pain Outcomes | 6.9 score on a scale | Standard Deviation 2.1 |
| Peri-Articular Injections, Adductor Canal Block, and IPACK | Pain Outcomes | 5.6 score on a scale | Standard Deviation 2.5 |