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

Knee Arthropathy Clinical Trial

— IPACK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094663
• Other study ID #: 2016-0168
• Status: Completed
• Phase: Phase 4
• Start date: February 28, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: December 2023
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 1, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Knee Arthropathy

Intervention

Drug:
• Bupivacaine with epinephrine
bupivacaine 0.5% with epinephrine 30cc
• Methylprednisolone
40 mg/ml, 1 ml
• Cefazolin
500 mg in 10 ml

Device:
• 8 MHz. Chiba needle
22G/ 4 inches

Drug:
• Bupivacaine with Dexamethasone
15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone
• Bupivacaine 25cc
25 cc 0.25% bupivacaine
• Bupivacaine 20cc
20cc 0.25% bupivacaine
• Dexamethasone
2 mg IV dexamethasone.

Locations

Country	Name	City	State
United States	Hospital For Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	24 hours post block administration
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.	24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3
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.	24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3
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.	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
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.	Post-Operative Day 2
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.	Post-Operative Day 1 and Post-Operative Day 2, average across the two time points reported
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.	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
Secondary	Opioid Related Symptom Distress Scale (ORSDS)	ORSDS scores. A lower score is a better outcome. range is 0 to 4.	Post-Operative Day 1 and Post-Operative Day 2
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.	Measured at pre-operation (day of surgery) and 6 weeks post-operation