NCT07433803

Brief Summary

This study aims to compare the effects of two regional analgesia techniques applied in patients undergoing unilateral total knee arthroplasty-Infiltration between the Popliteal Artery and the Capsule of the Knee (iPACK) block and the Biceps Femoris Short Head Plane (BiFeS) block-on ease of application, postoperative pain scores, time to mobilization, total postoperative opioid consumption, need for first rescue analgesia, and the incidence of nausea-vomiting and pruritus.All patients will be followed postoperatively according to a standard pain management protocol, and pain assessments will be performed at predetermined time intervals using the VAS (Visual Analog Scale).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
4mo left

Started May 2026

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress6%
May 2026Sep 2026

First Submitted

Initial submission to the registry

February 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

February 19, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

BiFeS BlockiPACK BlockPostoperative pain scoresTime to mobilizationTotal opioid consumption

Outcome Measures

Primary Outcomes (1)

  • VAS Scores

    A score of 0 indicates no pain, while a score of 10 represents the worst pain imaginable.

    Postoperative 8th-hour

Secondary Outcomes (3)

  • VAS Scores

    Postoperative 2,4,6,12,24th-hour rest and movement

  • Total opioid consumption

    24 hours after surgery

  • Time to first mobilization

    24 hours after surgery

Study Arms (2)

iPACK Block

ACTIVE COMPARATOR

At the end of surgery, all patients will receive an adductor canal block in the recovery unit under sterile conditions and ultrasound guidance using 10 mL of 0.25% bupivacaine. In addition, in the iPACK block group, the patient will be positioned in the lateral decubitus position, and under sterile conditions, a linear ultrasound probe will be used to advance a 22G, 100-mm block needle to the space between the popliteal artery and the posterior capsule of the knee. After negative aspiration, an iPACK block will be performed with 25 mL of 0.25% bupivacaine.

Procedure: IPACK block

BiFeS Block

OTHER

At the end of surgery, all patients will receive an adductor canal block in the recovery unit under sterile conditions and ultrasound guidance using 10 mL of 0.25% bupivacaine. In addition, in the BiFeS block group, with the patient in the supine position and under sterile conditions, a linear ultrasound probe will be used, and a 22G, 100-mm block needle will be advanced to the space between the short head of the biceps femoris muscle and the lateral epicondyle of the femur. After negative aspiration, the BiFeS block will be performed using 25 mL of 0.25% bupivacaine.

Procedure: BiFeS Block

Interventions

IPACK blockPROCEDURE

Unilateral iPACK block with 25 mL of mixture 1:1 (0.5 % bupivacaine: 0.9% NaCl)

iPACK Block
BiFeS BlockPROCEDURE

Unilateral BiFeS block with 25 mL of mixture 1:1 (0.5 % bupivacaine: 0.9% NaCl)

BiFeS Block

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for unilateral total knee arthroplasty
  • Patients aged between 18 and 75 years
  • Patients with ASA physical status I-III

You may not qualify if:

  • Patients with neuropsychiatric disorders
  • Patients with obesity (BMI \> 30)
  • Presence of local infection at the site where the block will be performed
  • Patients with coagulation disorders
  • Patients with uncontrolled diabetes mellitus
  • Opioid dependence
  • History of allergy to local anesthetic agents
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soma State Hospital

Manisa, Soma, 45500, Turkey (Türkiye)

Location

Related Publications (3)

  • Kilicaslan A, Tulgar S, Ahiskalioglu A, Aycan IO, Kekec AF, Arici AG, Kilic G, Sindel M. Ultrasound-guided biceps femoris short head block: a novel regional anesthesia technique for the posterolateral knee. Pain Med. 2025 Nov 1;26(11):726-732. doi: 10.1093/pm/pnaf068.

  • Sarikaya Ozel E, Taflan MG. Ultrasound-Guided Biceps Femoris Short Head Block for Posterolateral Knee Analgesia After Total Knee Arthroplasty: A Case Report. A A Pract. 2025 Sep 23;19(9):e02060. doi: 10.1213/XAA.0000000000002060. eCollection 2025 Sep 1.

  • Akesen S, Akesen B, Atici T, Gurbet A, Ermutlu C, Ozyalcin A. Comparison of efficacy between the genicular nerve block and the popliteal artery and the capsule of the posterior knee (IPACK) block for total knee replacement surgery: A prospective randomized controlled study. Acta Orthop Traumatol Turc. 2021 Mar;55(2):134-140. doi: 10.5152/j.aott.2021.20187.

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Meltem Savas Ozdemir, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a prospective, randomized, double-blind, non-inferiority clinical trial.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD., specialist

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 25, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 16, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations