NCT07643883

Brief Summary

Total knee arthroplasty (TKA) is among the most frequently performed surgical procedures for degenerative joint diseases, including advanced knee osteoarthritis, rheumatoid arthritis, and post-traumatic arthritis. More than 700,000 TKA procedures are performed annually in the United States alone since 2012, with projections estimating a 143% increase by 2050. A significant proportion of patients experience moderate to severe postoperative pain following the procedure, adversely affecting early mobilization, adherence to rehabilitation programs, and ultimately functional recovery . Femoral nerve block (FNB) was historically the cornerstone of TKA analgesia; however, concerns about quadriceps weakness and associated fall risk led to its replacement by more motor-sparing alternatives . Adductor canal block (ACB) has since become the standard approach, providing analgesia equivalent to FNB while significantly preserving quadriceps strength . Nevertheless, ACB does not adequately cover the posterior capsule and popliteal plexus terminals; consequently, 60-80% of TKA patients report significant posterior knee pain that cannot be sufficiently managed by ACB alone . To address this limitation, several posterior knee analgesia techniques have been described. The IPACK (Interspace between Popliteal Artery and Capsule of the Knee) block targets genicular nerve branches and popliteal plexus terminals by injecting local anesthetic between the popliteal artery and the posterior knee capsule, largely sparing the main motor trunks and providing selective posterior analgesia . The adductor magnus muscle plane (AMM) block is a relatively novel interfascial plane block technique applicable in the supine position simultaneously with ACB. By injecting local anesthetic into the fascial plane along the posterior surface of the adductor magnus muscle, the AMM block aims to spread to the popliteal plexus and posterior capsular branches, potentially mimicking a sciatic nerve block effect . A key advantage of the AMM block is its applicability without patient repositioning during the same session as ACB. The primary objective of this prospective randomized trial was to compare the effects of IPACK and AMM blocks-both added to ACB-on postoperative opioid consumption in patients undergoing TKA. Secondary objectives included evaluating the impact of each technique on postoperative pain scores, mobilization time, functional recovery, and motor function

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

May 22, 2026

Last Update Submit

June 10, 2026

Conditions

Keywords

Postoperative AnalgesiaPosterior Knee PainUltrasound-Guided Nerve Block

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    Postoperative opioid consumption

    [Time Frame: 0-4 hours, 4-8 hours, 8-24 hours, Total 24-hour]

Secondary Outcomes (4)

  • Pain Scores (VAS) at Rest and During Movement

    [Time Frame: PACU, 1st hour, 2nd hours, 4th hours, 8th hours, 12th hours, 24th hours,48th hours,]

  • Adverse Effects

    [Time Frame: up to 24 hours]

  • Evaluation of Nerve Blockade after Nerve Block Application

    [Time Frame: 5., 10., 15., 20., 30., and 45. minutes]

  • Quadriceps and Anterior Tibialis Muscle Strength

    [Time Frame: 4th hours, 8th hours, 12th hours, 24th hours, 48th hours]

Study Arms (2)

ACB+IPACK

ACTIVE COMPARATOR

Participants in this arm will receive an ultrasound-guided adductor canal block (20 mL of 0.25% bupivacaine) and IPACK block (20 mL of 0.25% bupivacaine) before surgery. Blocks will be performed under sterile ultrasound guidance by an experienced anesthesiologist who will not participate in postoperative assessments. All patients will receive standardized spinal anesthesia and perioperative analgesia

Procedure: ACB+IPACK

ACB+AMM

ACTIVE COMPARATOR

Adductor Canal + Adductor Magnus Muscle Plane block: Participants in this arm will receive an ultrasound-guided anterior sciatic nerve block (20 mL of 0.25% bupivacaine) and an adductor canal block (20 mL of 0.25% bupivacaine) before surgery. Blocks will be performed under sterile ultrasound guidance by an experienced anesthesiologist who will not participate in postoperative assessments. All patients will receive standardized spinal anesthesia and perioperative analgesia.

Procedure: ACB+AMM

Interventions

ACB+IPACKPROCEDURE

With the patients in the supine position and the knee slightly externally rotated, the ultrasound transducer will be placed transversely on the medial aspect of the knee, approximately 2-3 cm above the patella. After identifying the distal femoral shaft and the popliteal artery, the needle will be advanced in-plane in an anteromedial direction toward the space between the popliteal artery and the femur. Following negative aspiration and confirmation with normal saline, 10 mL of 0.5% bupivacaine and 10 mL of 0.9% NaCl will be administered, with aspiration performed every 5 mL. Needle tip visibility, needle shaft visibility, number of needle insertions, and block duration will be recorded for all procedures. Dermatomal spread of the tibial, peroneal, sural, saphenous, and posterior femoral cutaneous nerves (PFCN) will be assessed at predefined time points: 5, 10, 15, 20, 30, and 45 minutes after block administration.

ACB+IPACK
ACB+AMMPROCEDURE

With patients supine and the leg slightly abducted and externally rotated, the ultrasound probe will be placed 10-15 cm distal to the inguinal crease and moved medially to visualize the adductor muscles. The needle will be advanced in-plane from anteromedial to posterolateral, avoiding the femoral vessels and obturator nerve, until a fascial "pop" indicates entry into the posterior compartment. After negative aspiration and saline confirmation, 10 mL of 0.5% bupivacaine and 10 mL of 0.9% NaCl will be injected. In the AMM group, the adductor canal block will be performed by redirecting the same needle without a second puncture; in the IPACK group, a separate insertion will be used. Dermatomal spread will be assessed at 5, 10, 15, 20, 30, and 45 minutes after block administration.

ACB+AMM

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Anesthesiologists (ASA) physical status I-II-III
  • Total Knee Arthroplasty Surgery

You may not qualify if:

  • cardiovascular disease,
  • hepatic dysfunction,
  • coagulopathy or current use of anticoagulant therapy,
  • inability to cooperate,
  • known allergy to any of the study medications,
  • refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ahmet Murat Yayık

    m_yayik@hotmail.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants and outcome assessors will remain blinded to group allocation. The anesthesiologist performing the block procedures will not participate in postoperative assessments.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr. Ahmet Murat YAYIK

Study Record Dates

First Submitted

May 22, 2026

First Posted

June 12, 2026

Study Start

October 10, 2023

Primary Completion

January 10, 2024

Study Completion

February 6, 2026

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations