NCT06423339

Brief Summary

The patients will be randomized into 2 groups, named group A, B. Group A: The patients will receive Ultrasound guided Genicular nerves block combined with Ultrasound guided IPACK block. Group B: The patients will receive Adductor canal block which will be the control group. The Numerical Rating Scale (NRS) will be used to assess pain intensity. Preoperatively, all study subjects will be trained to use NRS pain scores. The spinal block will be performed. In group A, 15 mL of bupivacaine 0.25% with 2.5 g/mL adrenaline at a concentration 1:4,00,000 will be administered immediately following skin closure. GNB will be performed by using the linear ultrasound probe (10-15 MHz) Sono site M-turbo ultrasonography to scan the long bone shaft with up and down movement to recognize the epicondyle of the tibia and femur. The junctions between the epicondyle and the shafts of the femur and tibia are where the genicular arteries are located; these junctions will be defined as the periosteal areas. The superior lateral, superior medial and inferior medial genicular arteries accompany each genicular nerve. After confirmation of the genicular artery by color Doppler, the needle will be introduced using the in-plane approach and presented in the long axis view. The target point of the needle insertion will be the needle tip beside a genicular artery. Then, a 5 mL volume will be administered after gentle aspiration to prevent a faulty intra-arterial injection at 3 target locations: the superior lateral, superior medial and inferior medial genicular nerves. This will be Followed by the procedure for the IPACK block. In group B, A 22 Gauge 80 mm needle will be guided from lateral to medial to this area called the adductor canal using in-plane technique. 20 mL of 0.5% bupivacaine will be injected with peri-arterial spread after negative aspiration under sterile conditions. TKA will be performed by an orthopedic surgeon by placing three-compartment prostheses with a minimally invasive mini-midvastus approach and using hand-mixed cementing techniques.

Trial Health

87
On Track

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
Completed

Started May 2024

Shorter than P25 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

First Submitted

Initial submission to the registry

April 27, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

May 10, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 21, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

April 27, 2024

Last Update Submit

January 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will be the total postoperative morphine consumption during the first two postoperative days.

    The primary outcome will be the total postoperative morphine consumption during the first two postoperative days.

    48 hours

Study Arms (2)

Group A

EXPERIMENTAL

Group A will receive genicular nerve block combined with interspace between the popliteal artery and the capsule of the posterior knee block(IPACK)

Procedure: Ultrasound guided Genicular nerve blockProcedure: Interspace between the popliteal artery and the capsule of the popliteal artery and the capsule of the posterior kneeDrug: Bupivacaine Hydrochloride

Group B

EXPERIMENTAL

Group B will receive ultrasound guided sub-sartorial Adductor canal block (ACB)

Procedure: Adductor canal blockDrug: Bupivacaine Hydrochloride

Interventions

Ultrasound guided genicular nerve block

Group A

Ultrasound guided Interspace between the popliteal artery and the capsule of the popliteal artery and the capsule of the posterior knee

Group A

Ultrasound guided sub-sartorial Adductor canal block

Group B

Pupivacaine 0.5% in 20 ml vial

Also known as: Sunnypivacaine
Group AGroup B

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients American Society of anesthesiologists' physical status (ASA) I to III.
  • Aged 40 to 70 years.
  • Both sexes.
  • Patients scheduled for unilateral total knee replacement.

You may not qualify if:

  • Patients with spinal malformation
  • Patients with liver impairment
  • Patients with renal impairment
  • Patients younger than 40 years or older than 70 years
  • Patients with hypersensitivity to one of the used drugs
  • Patients with neuromuscular disorders and
  • Coagulopathy disorders
  • Patients scheduled for revision knee arthroplasty or those who had a past history of previous surgery or trauma to the knee

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university hospitals

Cairo, Egypt

Location

Related Publications (1)

  • Abouseeda MM, Rashed MM, Hussein MM, Nady RF, Ehab AM. A Comparative Study Between Ultrasound-Guided Genicular Nerve Block Combined With Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee Block versus Adductor Canal Block in Total Knee Replacement. Anesthesiol Res Pract. 2025 May 22;2025:8937826. doi: 10.1155/anrp/8937826. eCollection 2025.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 27, 2024

First Posted

May 21, 2024

Study Start

May 10, 2024

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations