iPACK Block for Total Knee Arthroplasty

• Sponsor: Poznan University of Medical Sciences (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06087562
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 54.5
• Patients Per Site Per Month: 6.4

Study Details

Study Description

Brief Summary

This randomized, double-blinded, placebo-controlled trial seeks to evaluate the efficacy of the rehabilitation process of the Interspace between the Popliteal Artery and Capsule of the Posterior Knee (iPACK) block in total knee arthroplasty.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis; Knee Pain Chronic; Knee Disease	Drug: Ropivacaine 0.5% Injectable Solution 20mL; Drug: 0,9% normal saline 20mL	Phase 4

Detailed Description

The Interspace between the Popliteal Artery and Capsule of the Posterior Knee (iPACK) block, has been recently described and shows promise in providing analgesia to the knee joint. The effect of this block on postoperative rehabilitation is uncertain. This study aims to compare a preoperative iPACK block to a placebo block prior to total knee arthroplasty under spinal anesthesia. The primary outcome measure is verticalization, walking distance, ability to go out of bed, active lifting of the limb, range of motion in the hip joint, bending range of motion, and abduction range of motion. The secondary measure is postoperative pain assessment during rehabilitation.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, triple-blind, placebo-controlledRandomized, triple-blind, placebo-controlled
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: Subjects will be randomized to one of two groups with a computer-generated arm assignment. The sealed envelopes will be opened immediately before the nerve block. One group will receive an iPACK block, and the other will receive a placebo block. The provider performing the league will not be blinded. However, all other care team members, the patient, and the investigator collecting data will be blinded to randomization.
• Primary Purpose: Treatment
• Official Title: Interspace Between the Popliteal Artery and Capsule of the Posterior Knee (iPACK) Block for Postoperative Rehabilitation in Total Knee Arthroplasty: a Randomized Control Trial
• Actual Study Start Date: Jun 16, 2020
• Anticipated Primary Completion Date: Sep 30, 2024
• Anticipated Study Completion Date: Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: preop iPACK block Patients will receive a preoperative ultrasound-guided Interspace between the Popliteal Artery and Capsule of the Posterior Knee (iPACK) block with 20 mL 0.5% ropivacaine. Using appropriate sterile precautions, and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindray TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the distal femoral shaft and popliteal artery. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in-plane, from the anteromedial aspect of the knee, toward the space between the popliteal artery and femur. 20 mL 0.5% ropivacaine is injected into the space between the popliteal artery and femur. The needle is withdrawn, and the needle entry site is wiped clean.	Drug: Ropivacaine 0.5% Injectable Solution 20mL; Ultrasound-guided iPACK block with 20mL of 0,5% ropivacaine; Other Names: Ropimol
Experimental: preop placebo block Patients will receive a preoperative ultrasound-guided Interspace between the Popliteal Artery and Capsule of the Posterior Knee (iPACK) block with 20 mL 0.5% ropivacaine. Using appropriate sterile precautions, and procedural sedation with up to 2 mg IV midazolam, an ultrasound (Mindray TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the distal femoral shaft and popliteal artery. After spinal anesthesia, a 22g 80 mm echogenic block needle (Stimuplex Ultra 360) is advanced lateral to medial, in-plane, from the anteromedial aspect of the knee, toward the space between the popliteal artery and femur. 20 mL 0.9% normal saline is injected into the space between the popliteal artery and femur. The needle is withdrawn, and the needle entry site is wiped clean.	Drug: 0,9% normal saline 20mL; Ultrasound-guided placebo block with 20mL of 0,9% normal saline; Other Names: placebo

Outcome Measures

Primary Outcome Measures

1. Numerical Rating Scale [Range from 0:no pain to 10:the worst pain] [within 24 hours postoperatively]

   Numerical Rating Scale [Range from 0:no pain to 10:the worst pain]

2. Numerical Rating Scale [Range from 0:no pain to 10:the worst pain] [1 st postoperative day]

   NRS (numerical rating scale from 0- no pain to 10- the worst pain)

3. Numerical Rating Scale [Range from 0:no pain to 10:the worst pain] [2nd postoperative day]

   NRS (numerical rating scale from 0- no pain to 10- the worst pain)

4. Numerical Rating Scale [Range from 0:no pain to 10:the worst pain] [5 th postoperative day]

   NRS (numerical rating scale from 0- no pain to 10- the worst pain)

5. Opioid consumption 24 hours postoperatively [24 hours postoperatively]

   intravenous morphine equivalents (mg)

6. Opioid consumption 48 hours postoperatively [24-48 hours postoperatively]

   intravenous morphine equivalents (mg)

7. Opioid consumption 72 hours postoperatively [48-72 hours postoperatively]

   intravenous morphine equivalents (mg)

8. Opioid consumption >72 hours postoperatively [72-96 hours postoperatively]

   intravenous morphine equivalents (mg)

9. Time to first opioid administration [0-12 hours postoperatively]

   hours

Secondary Outcome Measures

1. Rehabilitation process Verticalization by the balcony [1st postoperative day]

   Verticalization by the balcony (binary outcome yes or no)

2. Rehabilitation process Verticalization by the balcony [2nd postoperative day]

   Verticalization by the balcony (binary outcome yes or no)

3. Rehabilitation process Verticalization by the balcony [5th postoperative day]

   Verticalization by the balcony (binary outcome yes or no)

4. Rehabilitation process Verticalization with help [1st postoperative day]

   Verticalization- with help (yes/no)

5. Rehabilitation process Verticalization with help [2nd postoperative day]

   Verticalization- with help (yes/no)

6. Rehabilitation process Verticalization with help 5th day [5th postoperative day]

   Verticalization- with help (yes/no)

7. Rehabilitation process Verticalization - impossible 1st day [1st postoperative day]

   Verticalization- impossible (yes/no)

8. Rehabilitation process Verticalization - impossible 2nd day [2nd postoperative day]

   Verticalization- impossible (yes/no)

9. Rehabilitation process Verticalization - impossible 5th day [5th postoperative day]

   Verticalization- impossible (yes/no)

10. Rehabilitation process Walking distance- unlimited with crutches 1st day [1st postoperative day]

    Walking distance- unlimited with crutches (yes/no)

11. Rehabilitation process Walking distance- unlimited with crutches 2nd day [2nd postoperative day]

    Walking distance- unlimited with crutches (yes/no)

12. Rehabilitation process Walking distance- unlimited with crutches 5th day [5th postoperative day]

    Walking distance- unlimited with crutches (yes/no)

13. Rehabilitation process Walking distance- by the balcony 1st day [1st postoperative day]

    Walking distance- by the balcony (yes/no)

14. Rehabilitation process Walking distance- by the balcony 2nd day [2nd postoperative day]

    Walking distance- by the balcony (yes/no)

15. Rehabilitation process Walking distance- by the balcony 5th day [5th postoperative day]

    Walking distance- by the balcony (yes/no)

16. Rehabilitation process Walking distance- impossible- bed bound 1st day [1st postoperative day]

    Walking distance- impossible- bed bound (yes/no)

17. Rehabilitation process Walking distance- impossible- bed bound 2nd day [2nd postoperative day]

    Walking distance- impossible- bed bound (yes/no)

18. Rehabilitation process - getting out of bed- no problems 1st day [1st postoperative day]

    getting out of bed with no problems (yes/no)

19. Rehabilitation process - getting out of bed- no problems 2nd day [2nd postoperative day]

    getting out of bed with no problems (yes/no)

20. Rehabilitation process - getting out of bed- no problems 5th day [5th postoperative day]

    getting out of bed with no problems (yes/no)

21. Rehabilitation process - getting out of bed- with help 1st day [1st postoperative day]

    getting out of bed with help (yes/no)

22. Rehabilitation process - getting out of bed- with help 2nd day [2nd postoperative day]

    getting out of bed with help (yes/no)

23. Rehabilitation process - getting out of bed- with help 5th day [5th postoperative day]

    getting out of bed with help (yes/no)

24. Rehabilitation process - getting out of bed- with assistance 1st day [1st postoperative day]

    getting out of bed with assistance (yes/no)

25. Rehabilitation process - getting out of bed- with assistance 2nd day [2nd postoperative day]

    getting out of bed with assistance (yes/no)

26. Rehabilitation process - getting out of bed- with assistance 5th day [5th postoperative day]

    getting out of bed with assistance (yes/no)

27. Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 1st day [1st day postoperative day]

    CONTRACTURE IN THE KNEE JOINT - full extension (yes/no)

28. Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 2nd day [2nd day postoperative day]

    CONTRACTURE IN THE KNEE JOINT - full extension (yes/no)

29. Rehabilitation process - RANGE OF MOTION - CONTRACTURE IN THE KNEE JOINT - full extension- 5th day [5th day postoperative day]

    CONTRACTURE IN THE KNEE JOINT - full extension (yes/no)

30. Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 1st day [1st day postoperative day]

    flexion contracture IN THE KNEE JOINT (yes/no)

31. Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 2nd day [2nd day postoperative day]

    flexion contracture IN THE KNEE JOINT (yes/no)

32. Rehabilitation process - RANGE OF MOTION - flexion contracture IN THE KNEE JOINT - full extension- 5th day [5th day postoperative day]

    flexion contracture IN THE KNEE JOINT (yes/no)

33. Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 1st day [1st day postoperative day]

    bending range of motion- passive movement to 45 degrees with no pain- (yes/no)

34. Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 1st day [1st day postoperative day]

    bending range of motion- passive movement to 45 degrees with pain- (yes/no)

35. Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 2nd day [2nd day postoperative day]

    bending range of motion- passive movement to 45 degrees with no pain- (yes/no)

36. Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 2nd day [2nd day postoperative day]

    bending range of motion- passive movement to 45 degrees with pain- (yes/no)

37. Rehabilitation process - bending range of motion- passive movement to 45 degrees- no pain- 5th day [5th day postoperative day]

    bending range of motion- passive movement to 45 degrees with no pain- (yes/no)

38. Rehabilitation process - bending range of motion- passive movement to 45 degrees- with pain- 5th day [5th day postoperative day]

    bending range of motion- passive movement to 45 degrees with pain- (yes/no)

39. Rehabilitation process - bending range of motion- active movement to 90 degrees- no pain- 5th day [1st day postoperative day]

    bending range of motion- active movement to 90 degrees with no pain- (yes/no)

40. Rehabilitation process - bending range of motion- active movement to 90 degrees- no pain- 2nd day [2nd day postoperative day]

    bending range of motion- active movement to 90 degrees with no pain- (yes/no)

41. Rehabilitation process - bending range of motion- active movement to 90 degrees- no pain- 1st day [1st day postoperative day]

    bending range of motion- active movement to 90 degrees with no pain- (yes/no)

42. Rehabilitation process - bending range of motion- active movement to 90 degrees- with pain- 1st day [1st day postoperative day]

    bending range of motion- active movement to 90 degrees with pain- (yes/no)

43. Rehabilitation process - bending range of motion- active movement to 90 degrees- with pain- 2nd day [2nd day postoperative day]

    bending range of motion- active movement to 90 degrees with pain- (yes/no)

44. Rehabilitation process - bending range of motion- active movement to 90 degrees- with pain- 5th day [5th day postoperative day]

    bending range of motion- active movement to 90 degrees with pain- (yes/no)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients > 18 years old undergoing unilateral total knee arthroplasty

Exclusion Criteria:

• refusal to participate

• < 18 yo

• Chronic opioid use

• localized infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Poznan University of Medical Sciences	Poznan	Wielkopolska	Poland	61-701

Sponsors and Collaborators

• Poznan University of Medical Sciences

Investigators

• Principal Investigator: Małgorzata Domagalska, PhD, Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland
• Study Chair: Zbigniew Żaba, PhD, Department of Emergency Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poznan University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT06087562
• Other Study ID Numbers: 495/20
• First Posted: Oct 18, 2023
• Last Update Posted: Oct 18, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Poznan University of Medical Sciences: iPACK block; regional anesthesia; multimodal analgesia; total knee arthroplasty
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Ropivacaine

Study Results

No Results Posted as of Oct 18, 2023