NCT06188806

Brief Summary

to investigate the effect of adductor canal block applied with two different approaches in the treatment of pain after TKA surgery on pain control and functional mobility.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

November 10, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 18, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

2.3 years

First QC Date

December 18, 2023

Last Update Submit

November 16, 2025

Conditions

Keywords

adduktor canal block,knee artroplasti,postoperative pain

Outcome Measures

Primary Outcomes (1)

  • VISUAL ANALOGUE SCALE(VAS)

    VAS pain score was evaluated as "no pain" (score=0) and "worst pain" (score=10) and was divided into 3 groups according to the World Health Organization's pain intensity scale: score \<3 mild pain, 3-6 mild-moderate. degree pain and \>6 moderate-severe pain.

    POSTOPERATIVE 6, 12 AND 24 HOURS

Secondary Outcomes (3)

  • first mobilization time

    within postoperative 24 hours

  • length of hospital stay

    ONE WEEK

  • opioid use

    within postoperative 24 hours

Study Arms (3)

PROXİMAL ADDUKTOR CANAL BLOCK GROUP

ACTIVE COMPARATOR

Patients are placed in the supine position and a high-frequency linear probe is inserted for a cross-sectional image of the groin and thigh. The femoral nerve is identified in the short axis near the inguinal crease and the ultrasound transducer is placed caudally beyond the femoral triangle. The location of the proximal block is determined where the superficial femoral artery passes under the medial border of the sartorius muscle (usually 8-12 cm distal to the inguinal crease). Using the in-plane technique, a 100 mm peripheral nerve block needle is advanced until the tip of the needle passes the sartorius muscle and enters the adductor canal from the lateral side of the superficial femoral artery, and 20 mL 0.375% Bupivacaine is administered. To verify block success, sensory function is assessed by pinprick testing along the saphenous nerve distribution by comparing the pinprick sensation to the unaffected limb.

Other: ADDUKTOR CANAL BLOCK

DİSTAL ADDUKTOR CANAL BLOCK GROUP

ACTIVE COMPARATOR

Patients are placed in the supine position, the mid-thigh point is determined as half the distance between the groin crease and the top of the patella. After the mid-thigh mark is marked with a sterile marking pen, the ultrasound transducer is positioned for a transverse view of the adductor canal into the mid-thigh. Under USG imaging, the femoral artery and saphenous nerve are identified. The distal position is determined where the USG probe moves away from the sartorius muscle of the femoral artery and proceeds deep into the adductor hiatus, and a 100 mm block needle passes the sartorius muscle with an in plane technique and 20 mL 0.375% Bupivacaine is administered to the lateral side of the femoral artery and saphenous nerve.

Other: ADDUKTOR CANAL BLOCK

CONTROL GROUP

SHAM COMPARATOR

No nerve block procedure is applied to patients.

Other: CONTROL GROUP

Interventions

All patients who will undergo adductor canal block are sedated with midazolam 0.03 mg/kg in the preoperative preparation room, after standard monitoring. After 2-3 ml skin infiltration with 2% lidocaine under sterile conditions, a block is applied under USG guidance.To verify block success, sensory function is assessed by pinprick testing along the saphenous nerve distribution by comparing the pinprick sensation to the unaffected limb.All patients are monitored in the operating room and in a sitting position, 10-20 mg (2-4 ml) of heavy marcaine (0.5% bupivacaine hydrochloride and dextrose monohydrate) is applied to the subarachnoid space by entering the L3-4 or L4-5 space with a 25-gauge Whitrace needle.For postoperative multimodal analgesia, which is routinely applied to all patients, intravenous PCA (patient controlled analgesia )tramadol and paracetamol 10 mg / kg iv (8 hours apart) will be given.

DİSTAL ADDUKTOR CANAL BLOCK GROUPPROXİMAL ADDUKTOR CANAL BLOCK GROUP

No nerve block procedure is applied to patients.All patients are monitored in the operating room and in a sitting position, 10-20 mg (2-4 ml) of heavy marcaine (0.5% bupivacaine hydrochloride and dextrose monohydrate) is applied to the subarachnoid space by entering the L3-4 or L4-5 space with a 25-gauge Whitrace needle.For postoperative multimodal analgesia, which is routinely applied to all patients, intravenous PCA (patient controlled analgesia) tramadol 50 mg at 10 mg / hour basal rate after loading (20 mg bolus dose + 30 minutes lock time) and paracetamol 10 mg / kg iv (8 hours apart) will be given.

CONTROL GROUP

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medications for unilateral TKA surgery
  • Patients aged 18-85
  • ASA 1-3

You may not qualify if:

  • Patients under 18 years of age and over 85 years of age
  • Patients with ASA 4 and above
  • Patients with cognitive impairment
  • Patients with application site infection
  • Patients allergic to local anesthesia
  • Patients receiving anticoagulant therapy
  • Patients with bleeding diathesis
  • Patients with chronic opioid or substance use
  • Patients with insulin-dependent diabetes mellitus
  • patients with neuropathy
  • patients with hepatic or renal failure
  • Patients who do not accept the procedure to be applied

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umraniye Education and Research Hospital

Istanbul, Umraniye, 34734, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneePain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: three groups Group 1: proximal ACB (n:26) Group 2: distal ACB(n:26) Group 3: Control group (n:26)
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of Anesthesia and reanimation

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 3, 2024

Study Start

November 10, 2023

Primary Completion

February 27, 2026

Study Completion

March 30, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations