NCT07130552

Brief Summary

This study aims to investigate the effect of femoral triangle block combined with popliteal plexus block and distal IPACK block on postoperative pain after total knee arthroplasty (TKA)

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Aug 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Aug 2025Sep 2026

First Submitted

Initial submission to the registry

August 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

August 29, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2026

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

April 28, 2026

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

August 12, 2025

Last Update Submit

April 25, 2026

Conditions

Osteo Arthritis of the Knee

Keywords

Total knee arthroplastypopliteal plexus blockfemoral triangle blockiPACK block (infiltration of the interspace between the popliteal artery and the posterior knee capsule)

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    Total opioid consumption in each group, A, B until 24 hours postoperative.

    24 hours

Secondary Outcomes (11)

  • NRS scores

    48 hours

  • Range of knee motion

    48 hours

  • Patient mobilization

    48 hours

  • Post-block Maximum Voluntary Isometric Contraction (MVIC) by knee extension, calculated as a percentage of the Pre-block baseline value

    A 60-minute interval is between pre-block and post-block MVIC assessments

  • Post-block MVIC by ankle plantarflexion, calculated as a percentage of the Pre-block baseline value

    A 60-minute interval is between pre-block and post-block MVIC assessments

  • +6 more secondary outcomes

Study Arms (2)

Group Popliteal plexus block

EXPERIMENTAL

femoral triangle block and popliteal plexus block

Device: femoral triangle block and popliteal plexus block

Group distal iPACK

EXPERIMENTAL

Femoral triangle block and distal iPACK

Device: Femoral triangle block and distal iPACK

Interventions

femoral triangle block and popliteal plexus blockDEVICE

Single dose bolus, 10 ml 5% bupivacaine will be used for FTB, 10 ml 5% bupivacaine will be used for PPB

Group Popliteal plexus block
Femoral triangle block and distal iPACKDEVICE

Single dose bolus, 10 ml 5% bupivacaine will be used for FTB, 10 ml 5% bupivacaine will be used for distal iPACK

Group distal iPACK

Eligibility Criteria

Age18 Years - 85 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details18 Years and older (Adult, Older Adult)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing total knee arthroplasty under spinal anesthesia
  • American Society of Anesthesiologists (ASA) status I-III
  • Patients who give informed consent

You may not qualify if:

  • Patients unable to cooperate
  • Kidney disease with GFR \< 50 ml/min
  • Daily opioid consumption \> 1 month
  • Allergy to local anesthetics
  • Neurological problems of the lower extremity
  • Contraindications to peripheral nerve blocks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karaman Training and Research Hospital, Karaman, Karaman 70200

Karaman, 70200, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Tayfun Et

CONTACT

+905063670717drtayfunet@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2025

First Posted

August 19, 2025

Study Start

August 29, 2025

Primary Completion (Estimated)

September 25, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

April 28, 2026

Record last verified: 2025-06

Locations

TU(1)