NCT06201195

Brief Summary

This prospective clinical study was approved by the institutional ethics committee on September 27, 2023, and patient enrollment started in October 2023. the study aimed to evaluate the contribution of anterior femoral cutaneus nerve block to postoperative analgesia in total knee artroplasty. The goal of this clinical trial is to compare analhesia effects of adductor canal blockade versus distal adductur canal blockade added anterior cutaneus nerve block in total knee arthroplasty. The main questions it aims to answer are:

  • question 1: does distal adductor canal blockade + anterior cutaneus nerve blokade superior analgesia then adductor canal block for undergoing TKP?
  • question 2: does distal adductor canal blockade + anterior cutaneus nerve blokade decrease drain place pain on anterolateral face of knee?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

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

Study Start

First participant enrolled

October 1, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

October 25, 2023

Last Update Submit

November 15, 2025

Conditions

Keywords

anterior femoral cutaneus nerve blockdistal adductor canal blocktotal knee arthroplasthy

Outcome Measures

Primary Outcomes (2)

  • VAS (visuel analouge scale)

    for postoperative pain evaluation after TKA surgery. The visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end.

    postblock 3 hour,10 hour, 24 hour

  • drain place pain

    do you have any pain on drain place? yes or no

    postblock 3 hour,10 hour, 24 hour

Secondary Outcomes (2)

  • VAS movement

    postblock 3 hour,10 hour, 24 hour

  • motor strenght

    postblock 3 hour,10 hour, 24 hour

Study Arms (2)

Adductor canal block

ACTIVE COMPARATOR

Usg guidance adductor canal block with %0.25 Bupivacaine 20 ml

Procedure: Adductor canal blockade

Distal adductor canal block with anterior cutaneus nerve block

ACTIVE COMPARATOR

Usg guidance distal adductor canal block (%0.25 Bupivacaine 20 ml) with anterior cutaneus nerve block (%0.25 Bupivacaine 10 ml)

Procedure: Distal adductor canala blockade and anterior cutaneus nerve blockade

Interventions

VAS, VAS move, incision place pain for up and down to patella, drain place pain, motor strenght for femoral nerve and siyatic nerve muscles, side effects, first analgesic requirement time, opioid requirement, other analgesics

Also known as: first control
Adductor canal block

VAS, VAS move, incision place pain for up and down to patella, drain place pain, motor strenght for femoral nerve and siyatic nerve muscles, side effects, first analgesic requirement time, opioid requirement, other analgesics

Also known as: study group
Distal adductor canal block with anterior cutaneus nerve block

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Total knee artroplasty
  • Spinal anesthesia
  • ASA 1-3

You may not qualify if:

  • Bupivacaine allergy
  • Coagulopathy
  • Infection on injection site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • Bjorn S, Nielsen TD, Moriggl B, Hoermann R, Bendtsen TF. Anesthesia of the anterior femoral cutaneous nerves for total knee arthroplasty incision: randomized volunteer trial. Reg Anesth Pain Med. 2019 Dec 10:rapm-2019-100904. doi: 10.1136/rapm-2019-100904. Online ahead of print.

    PMID: 31826920BACKGROUND

Study Officials

  • Derya Ozkan

    Study Principal Investigator Ankara Etlik City Hospital

    STUDY DIRECTOR
  • Müge Çakırca, doctor

    Study Principal Investigator Ankara Etlik City Hospital

    PRINCIPAL INVESTIGATOR
  • Funda Atar, doctor

    Study Principal Investigator Ankara Etlik City Hospital

    STUDY CHAIR
  • Serhan ünlü, doctor

    Study Principal Investigator Ankara Etlik City Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 25, 2023

First Posted

January 11, 2024

Study Start

October 1, 2023

Primary Completion

March 31, 2024

Study Completion

June 30, 2024

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations