NCT06087562

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for phase_4 knee-osteoarthritis

Timeline
Completed

Started Jun 2020

Longer than P75 for phase_4 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2020

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2023

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

4.3 years

First QC Date

February 19, 2023

Last Update Submit

October 11, 2023

Conditions

Knee OsteoarthritisKnee Pain ChronicKnee Disease

Keywords

iPACK blockregional anesthesiamultimodal analgesiatotal knee arthroplasty

Outcome Measures

Primary Outcomes (9)

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

    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]

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

    1 st postoperative day

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

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

    2nd postoperative day

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

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

    5 th postoperative day

  • Opioid consumption 24 hours postoperatively

    intravenous morphine equivalents (mg)

    24 hours postoperatively

  • Opioid consumption 48 hours postoperatively

    intravenous morphine equivalents (mg)

    24-48 hours postoperatively

  • Opioid consumption 72 hours postoperatively

    intravenous morphine equivalents (mg)

    48-72 hours postoperatively

  • Opioid consumption >72 hours postoperatively

    intravenous morphine equivalents (mg)

    72-96 hours postoperatively

  • Time to first opioid administration

    hours

    0-12 hours postoperatively

Secondary Outcomes (44)

  • Rehabilitation process Verticalization by the balcony

    1st postoperative day

  • Rehabilitation process Verticalization by the balcony

    2nd postoperative day

  • Rehabilitation process Verticalization by the balcony

    5th postoperative day

  • Rehabilitation process Verticalization with help

    1st postoperative day

  • Rehabilitation process Verticalization with help

    2nd postoperative day

  • +39 more secondary outcomes

Study Arms (2)

preop iPACK block

EXPERIMENTAL

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

preop placebo block

EXPERIMENTAL

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

Interventions

Ropivacaine 0.5% Injectable Solution 20mLDRUG

Ultrasound-guided iPACK block with 20mL of 0,5% ropivacaine

Also known as: Ropimol
preop iPACK block
0,9% normal saline 20mLDRUG

Ultrasound-guided placebo block with 20mL of 0,9% normal saline

Also known as: placebo
preop placebo block

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \> 18 years old undergoing unilateral total knee arthroplasty

You may not qualify if:

  • refusal to participate
  • \< 18 yo
  • Chronic opioid use
  • localized infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences

Poznan, Wielkopolska, 61-701, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Małgorzata Domagalska, PhD

    Department of Palliative Medicine, University of Medical Sciences, Poznań, Poland

    PRINCIPAL INVESTIGATOR

  • Zbigniew Żaba, PhD

    Department of Emergency Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, triple-blind, placebo-controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2023

First Posted

October 18, 2023

Study Start

June 16, 2020

Primary Completion

September 30, 2024

Study Completion

December 30, 2024

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

The data presented in this study are available on request from the corresponding author.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
December 2024
Access Criteria
The data presented in this study are available on request from the corresponding author.

Locations

PL(1)