Skip to main content
OpenTrials
Completed

NCT Number: NCT03094663

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital For Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine with epinephrine

Drug

bupivacaine 0.5% with epinephrine 30cc

Other names: Sensorcaine/Epinephrine, Sensorcaine-MPF/Epinephrine, Marcaine-Epinephrine (PF)

methylprednisolone

Drug

40 mg/ml, 1 ml

Other names: Depo-Medrol, Solu-Medrol, Medrol

Cefazolin

Drug

500 mg in 10 ml

Other names: cephalosporin antibiotics

8 MHz. Chiba needle

Device

22G/ 4 inches

Bupivacaine with Dexamethasone

Drug

15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone

Other names: dexamethasone to non-liposomal bupivacaine

Bupivacaine 25cc

Drug

25 cc 0.25% bupivacaine

Other names: Exparel, Marcaine, Marcaine Spinal (PF)

Bupivacaine 20cc

Drug

20cc 0.25% bupivacaine

Other names: Exparel, Marcaine, Marcaine Spinal (PF)

Dexamethasone

Drug

2 mg IV dexamethasone.

Other names: Ozurdex, Maxidex, DexPak 6 Day

Primary outcomes

  1. Numeric Rating Scale (NRS) Pain Scores

    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

Secondary outcomes

  1. Opioid Consumption

    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.

  2. Numeric Rating Scale (NRS) Pain Scores at Rest and With Movement

    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.

  3. Ambulation Distance During Physical Therapy

    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.

  4. Level of Patient Satisfaction With Postoperative Pain Management

    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.

  5. Pain Outcomes

    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.

  6. Hospital Length of Stay

    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.

  7. Opioid Related Symptom Distress Scale (ORSDS)

    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.

  8. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr)

    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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study 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

Acronym: IPACK

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2017
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.