Knee Arthroplasty, Total
Conditions
Brief summary
This is a perspective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups to assess the analgesic efficacy of adding the iPACK (injection between the popliteal artery and the capsule of the knee) in addition to the adductor canal block (ACB) for Total Knee Arthoplasty patients (TKA).
Interventions
DRUGultrasound 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.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for total knee arthroplasty * American Society Anesthesiologists (ASA) physical status I- III. * Mentally competent and able to give consent for enrollment in the study.
Exclusion criteria
* Patient refusal, * allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3). * Revision surgery will be excluded. * Impaired kidney functions * patient with coagulopathy will be also excluded. * Chronic pain syndromes and patients with chronic opioid use in excess of a daily morphine equivalent dose (MED) of 40mg or greater for the past 3 months prior to the surgery. * BMI of 45 or more
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Presenting With Pain in the Back of the Knee 6 Hours After Surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Measurement Reported by Patients | 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. |
| Quality of Recovery (QoR) Score | 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). |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| 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. | 59 |
| Total | 119 |
Baseline characteristics
| Characteristic | ACB + iPACK | ACB w/o iPACK | Total |
|---|---|---|---|
| Age, Continuous | 67.7 Age (years) STANDARD_DEVIATION 7.8 | 65.6 Age (years) STANDARD_DEVIATION 8.2 | 66.7 Age (years) STANDARD_DEVIATION 8.03 |
| Race/Ethnicity, Customized African American | 14 Participants | 20 Participants | 34 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 45 Participants | 38 Participants | 83 Participants |
| Sex: Female, Male Female | 34 Participants | 35 Participants | 69 Participants |
| Sex: Female, Male Male | 26 Participants | 24 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 59 |
| other Total, other adverse events | 0 / 60 | 0 / 59 |
| serious Total, serious adverse events | 0 / 60 | 0 / 59 |
Outcome results
Primary
Percentage of Patients Presenting With Pain in the Back of the Knee 6 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
Time frame: Six hours after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACB + iPACK | Percentage of Patients Presenting With Pain in the Back of the Knee 6 Hours After Surgery | 21.7 percentage of patients reporting pain |
| ACB w/o iPACK | Percentage of Patients Presenting With Pain in the Back of the Knee 6 Hours After Surgery | 45.8 percentage of patients reporting pain |
Secondary
Pain Score Measurement Reported by Patients
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.
Time frame: 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACB + iPACK | Pain Score Measurement Reported by Patients | 5 pain scores | Standard Deviation 0.01 |
| ACB w/o iPACK | Pain Score Measurement Reported by Patients | 6 pain scores | Standard Deviation 0.01 |
Secondary
Quality of Recovery (QoR) Score
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).
Time frame: one week, measurements are obtained at 24 hours, 48 hours, and one week
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| ACB + iPACK | Quality of Recovery (QoR) Score | Postoperative Day 1 | 113 score on a scale | Standard Deviation 0.66 |
| ACB + iPACK | Quality of Recovery (QoR) Score | Postoperative Day 2 | 118 score on a scale | Standard Deviation 0.37 |
| ACB + iPACK | Quality of Recovery (QoR) Score | Postoperative Day 7 | 131 score on a scale | Standard Deviation 0.11 |
| ACB w/o iPACK | Quality of Recovery (QoR) Score | Postoperative Day 1 | 114 score on a scale | Standard Deviation 0.66 |
| ACB w/o iPACK | Quality of Recovery (QoR) Score | Postoperative Day 2 | 123 score on a scale | Standard Deviation 0.37 |
| ACB w/o iPACK | Quality of Recovery (QoR) Score | Postoperative Day 7 | 126 score on a scale | Standard Deviation 0.11 |