NCT06746168

Brief Summary

The goal of this study is to compare the anesthetic combination iPACK with femoral triangle block versus surgical LIA for unilateral TKA. We hypothesize that an iPACK block with femoral triangle block is non-inferior to surgical LIA. Furthermore, due to visualization of the relevant neural and vascular structures, the risk of accidental popliteal block, nerve damage or LAST with (a blindly performed) LIA could theoretically be reduced.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Jan 2025Nov 2027

First Submitted

Initial submission to the registry

December 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 24, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

January 9, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

February 20, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

December 17, 2024

Last Update Submit

February 18, 2025

Conditions

Knee Arthroplasty, Total

Keywords

iPACKFemoral Triangle BlockLocal infiltration analgesiaknee arthoplasty

Outcome Measures

Primary Outcomes (1)

  • Numerical Rating Scale (NRS) pain score at mobilization at 8 hour postoperatively

    The NRS pain score will be determined immediately after mobilizing patients from the bed to their seat at 8 hour postoperatively

    8 hours postoperatively

Secondary Outcomes (10)

  • NRS pain at movement for the first 24 hours

    24 hours postoperatively

  • NRS pain at rest for the first 24 hours

    24 hours postoperatively

  • Rate of popliteal block 8 hours after surgery

    8 hours postoperatively

  • Functional recovery: timed up and go test

    Baseline, 24 hours and 48 hours after surgery

  • Functional recovery: 30-second sit-to-stand-chair test

    Baseline, 24 hours and 48 hours after surgery

  • +5 more secondary outcomes

Study Arms (2)

iPACK with Femoral Triangle Block (FTB)

ACTIVE COMPARATOR

Patients undergoing an unillateral total kneearthroplasty will receive the anesthetic combination iPACK with FTB.

Procedure: Locoregional anesthesia

Surgical Local Infiltration Analgesia (LIA)

ACTIVE COMPARATOR

Patients undergoing an unillateral total kneearthroplasty will receive the surgical LIA.

Procedure: Local Anesthetic Ropivacaine

Interventions

Locoregional anesthesiaPROCEDURE

The FTB + iPACK group will receive 12 ml 0,5% ropivacaine for the FTB and 20 ml of ropivacaine 0.5% for the iPACK block under US guidance after spinal anesthesia

iPACK with Femoral Triangle Block (FTB)
Local Anesthetic RopivacainePROCEDURE

The control group (LIA) will receive 120 ml 0.25% ropivacaine for surgical LIA placement.

Surgical Local Infiltration Analgesia (LIA)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III
  • BMI 17-35 kg/m2
  • Patient is able to give informed consent
  • Patient is scheduled for TKA

You may not qualify if:

  • Refusal of patient
  • Inability to communicate due to language or neurologic barriers
  • Bilateral TKA or unilateral knee arthroplasty
  • Chronic opioid use (including partial opioid agonists) + chronic pain patients:
  • Use of atypical analgesics (gabapentin, pregabalin, …)
  • History of Sudeck atrophy
  • History of \>3 chronic pain consultations
  • Contraindications for spinal anesthesia
  • Patient refusal
  • Local infection
  • Aberrant coagulation (according to the latest ESRA guidelines)
  • Severe spinal canal stenosis
  • Intracranial hypertension
  • History of neurological injury in the affected limb
  • Contraindications for local anesthetics
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

RECRUITING

Central Study Contacts

Bjorn Stessel, MD, PhD

CONTACT

003211222107bjorn.stessel@jessazh.be

Ina Callebaut, PhD

CONTACT

003211339848ina.callebaut@jessazh.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 24, 2024

Study Start

January 9, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

November 30, 2027

Last Updated

February 20, 2025

Record last verified: 2025-01

Locations

BE(1)