Hospital For Special Surgery
New York, 10021, United States
NCT Number: NCT03094663
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).
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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
New York, 10021, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
bupivacaine 0.5% with epinephrine 30cc
Other names: Sensorcaine/Epinephrine, Sensorcaine-MPF/Epinephrine, Marcaine-Epinephrine (PF)
40 mg/ml, 1 ml
Other names: Depo-Medrol, Solu-Medrol, Medrol
500 mg in 10 ml
Other names: cephalosporin antibiotics
22G/ 4 inches
15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone
Other names: dexamethasone to non-liposomal bupivacaine
25 cc 0.25% bupivacaine
Other names: Exparel, Marcaine, Marcaine Spinal (PF)
20cc 0.25% bupivacaine
Other names: Exparel, Marcaine, Marcaine Spinal (PF)
2 mg IV dexamethasone.
Other names: Ozurdex, Maxidex, DexPak 6 Day
Time frame: 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
Time frame: 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.
Time frame: 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.
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
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: 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.
Time frame: 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.
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
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: Post-Operative Day 1 and Post-Operative Day 2
ORSDS scores. A lower score is a better outcome. range is 0 to 4.
Time frame: 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.
Hospital for Special Surgery, New York
Other
Analgesia After Total Knee Arthroplasty: Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI). A Double-Blinded Randomized Controlled Trial
Acronym: IPACK
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