NCT07418307

Brief Summary

The purpose of this study is to compare the analgesic outcomes (time to first analgesic request, total amount of analgesic consumption, and pain scores) following total knee arthroplasty by either combined biceps femoris short head block and adductor canal block or genicular nerve block in elderly patients.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Feb 2026

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Progress36%
Feb 2026Nov 2026

First Submitted

Initial submission to the registry

February 4, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 4, 2026

Last Update Submit

February 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time of first rescue analgesia (naluphine)

    to the duration from the block to the moment when the patient first requires or requests supplemental nalbuphine due to breakthrough pain

    24 hours postoperative

Secondary Outcomes (6)

  • block performance time

    time of performance of the block

  • Pain intensity

    30 minutesn2, 4, 8, 12, 18 , and 24 hours postoperative

  • Total amount of rescue analgesia (nalbuphine)

    first 24 hours postoperative

  • assess functional recovery

    at 12 hours and 24 hours postoperative

  • patient's satisfaction

    24 hours postoperative

  • +1 more secondary outcomes

Study Arms (2)

Group (C)

ACTIVE COMPARATOR

The patient will receive combined biceps femoris short head block and adductor canal block

Other: Combined biceps femoris short head block and adductor canal block

Group(G)

ACTIVE COMPARATOR

The patient will receive genicular nerve block

Other: Genicular nerve block

Interventions

Adductor Canal Block high-frequency probe will be placed transversely on the anterior thigh midpoint between inguinal crease and medial condyle (depth 3-5 cm). The needle will be advanced in-plane from lateral to medial through sartorius or vastus medialis muscle toward the femoral artery. Then (10 ml of 0.25% bupivacaine and 2 mg dexamethasone) will be injected after negative aspiration, with confirming spread around the artery without vascular puncture. Biceps femoris short head block The probe will be placed on the distal posterior thigh to visualize biceps femoris muscle near the lateral supracondylar line of the femur. The needle will be inserted to the interface between biceps femoris and femur cortex. Then (25 ml of 0.25% bupivacaine and 2 mg dexamethasone), with observing muscle lift and circumferential spread along the bone surface .

Group (C)

Position the patient will be placed in supine position with the knee slightly flexed via a pillow in the popliteal fossa. Use a high-frequency linear ultrasound transducer. Superolateral genicular nerve (SLGN): the transducer will be placed coronally over lateral femoral epicondyle, with sliding proximally to femur metaphysis; identifying artery between vastus lateralis fascia and bone. Superomedial genicular nerve (SMGN): the transducer will be placed coronally over medial femoral epicondyle, proximal to adductor tubercle at femur metaphysis; artery between vastus medialis fascia and bone. Inferomedial genicular nerve (IMGN): the transducer will be placed coronally over medial tibial condyle, distal to metaphysis; artery beneath medial collateral ligament. • Inferolateral genicular nerve (ILGN, optional): the transducer will be placed coronally over lateral tibial epicondyle to fibula head; artery between collateral ligament and tibia

Group(G)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • patient acceptance
  • Physical status: ASA I, II and Ⅲ.
  • Body mass index (BMI): 18.5 - 35 kg/m2.
  • Type of operations: total knee arthroplasty.

You may not qualify if:

  • Known hypersensitivity to dexamethasone or bupivacaine.
  • Coagulation disorders or taking drugs affect surgical hemostasis.
  • Patients with pre-existing neurological deficits.
  • Uncooperative patient or with altered mental status.
  • Patient with advanced cardiovascular or respiratory diseases or uncontrolled diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine,Zagazig University

Zagazig, Egypt

Location

Related Publications (1)

  • You D, Qin L, Li K, Li D, Zhao G, Li L.,et al. A meta-analysis on advantages of peripheral nerve block post-total knee arthroplasty. Korean J Pain 2021; 34:271-287.

    BACKGROUND

Study Officials

  • Howida A Kamal, M.D

    faculty of medicine,zagazig university Egypt

    STUDY DIRECTOR

Central Study Contacts

Marwa M Medhat, M.D

CONTACT

Howida A Kamal, M.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of anesthesia and surgical intensive care(Principal Investigator)

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 18, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

November 15, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations