NCT06864663

Brief Summary

The aim of this study is to investigate the effectiveness of combined adductor canal block (ACB) with interspace between popliteal artery and the knee capsule (IPACK) versus combined ACB with genicular nerve block (GNB) for providing analgesia in knee arthroplasty. The investigators hypothesize that the analgesic efficacy of ACB combined with GNB will be non-inferior to that of ACB combined with IPACK. Additionally, the investigators aim to assess whether the combination of ACB and GNB results in a significantly lower occurrence of sensory or motor block affecting the tibial and common peroneal nerves compared to ACB and IPACK

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

March 15, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

March 7, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

February 21, 2025

Last Update Submit

March 6, 2025

Conditions

Keywords

adductor canal blockinterspace between popliteal artery and capsule of kneeknee arthroplastygenicular nerve block

Outcome Measures

Primary Outcomes (1)

  • individual visual analog pain scores at 0, 6, 12 , 24 and 48 h postoperatively

    (VAS; 0 = no pain and 10 = worst pain imaginable)

    48 hours

Secondary Outcomes (5)

  • time to first reported pain and first analgesic request during post-anesthesia care unit stay

    48 hours

  • Analgesic consumption during the first 48 h post-surgery

    48 hours

  • Quadriceps muscle strength

    24 hours

  • The sensorimotor functions of the tibial nerve and common peroneal nerve (CPN) will be evaluated using a 3-point scale

    8 hours postoperative

  • Ambulation and mobilization ability

    48 hours

Study Arms (2)

Patients receiving combined ACB and IPACK blocks

ACTIVE COMPARATOR

ultrasound guided block of saphenous nerve in adductor canal and block of articular branches of knee between the popliteal artery and the knee capsule (IPACK)

Drug: Nerve Block with bupivacaine 0.25%

Patients receiving combined ACB and GNB

ACTIVE COMPARATOR

ultrasound guided block of saphenous nerve in adductor canal and block of the three peri-knee nerve branches: the superior medial genicular nerve (SMGN), inferior medial genicular nerve (IMGN), and superior lateral genicular nerve (SLGN)

Drug: nerve block with bupivacaine 0.25%

Interventions

ultrasound guided adductor canal block and interspace between the popliteal artery and the knee capsule using bupivacaine 0.25%

Patients receiving combined ACB and GNB

Eligibility Criteria

Age18 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 18 to 70 years.
  • Both sexes.
  • Patients scheduled for total knee arthroplasty.

You may not qualify if:

  • Patient refusal
  • ASA physical status IV or more.
  • Patients with known allergy to any of the study drugs.
  • Infection at the site of injection.
  • Patients with neuromuscular disease.
  • Presence of any coagulopathy.
  • Patients with history of any psychiatric or cognitive disorder.
  • patient with previous knee surgery.
  • BMI more than 40 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (4)

  • Kukreja P, Venter A, Mason L, Kofskey AM, Northern T, Naranje S, Ghanem E, Lawson PA, Kalagara H. Comparison of Genicular Nerve Block in Combination With Adductor Canal Block in Both Primary and Revision Total Knee Arthroplasty: A Retrospective Case Series. Cureus. 2021 Jul 29;13(7):e16712. doi: 10.7759/cureus.16712. eCollection 2021 Jul.

    PMID: 34471571BACKGROUND
  • Padhy S, Patki AY, Kar AK, Durga P, Sireesha L. Comparison of sensory posterior articular nerves of the knee (SPANK) block versus infiltration between the popliteal artery and the capsule of the knee (IPACK) block when added to adductor canal block for pain control and knee rehabilitation after total knee arthroplasty---A prospective randomised trial. Indian J Anaesth. 2021 Nov;65(11):792-797. doi: 10.4103/ija.ija_682_21. Epub 2021 Nov 23.

    PMID: 35001951BACKGROUND
  • Gonzalez Sotelo V, Macule F, Minguell J, Berge R, Franco C, Sala-Blanch X. Ultrasound-guided genicular nerve block for pain control after total knee replacement: Preliminary case series and technical note. Rev Esp Anestesiol Reanim. 2017 Dec;64(10):568-576. doi: 10.1016/j.redar.2017.04.001. Epub 2017 May 26. English, Spanish.

    PMID: 28554709BACKGROUND
  • Mu T, Yuan B, Wei K, Yang Q. Adductor canal block combined with genicular nerve block versus local infiltration analgesia for total knee arthroplasty: a randomized noninferiority trial. J Orthop Surg Res. 2024 Sep 6;19(1):546. doi: 10.1186/s13018-024-05048-5.

    PMID: 39238029BACKGROUND

Related Links

MeSH Terms

Interventions

Nerve Block

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized controlled interventional prospective study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2025

First Posted

March 7, 2025

Study Start

March 15, 2025

Primary Completion

September 30, 2025

Study Completion

October 15, 2025

Last Updated

March 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
from 20/2/2025 to 20/9/2025
Access Criteria
All researchers

Locations