NCT06686095

Brief Summary

Patients with total knee arthroplasty (TKA) experience severe postoperative pain. This reduces patient satisfaction, delays mobility, and prolongs hospital stay. Peripheral nerve blocks, which are part of multimodal analgesia, are widely used in postoperative pain management. In this study, the effects of adductor canal block (ACB), popliteal artery and knee capsule infiltration block (IPACK), and genicular nerve block (GSB) on postoperative VAS score, opioid consumption, and mobility were investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

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, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

November 7, 2024

Last Update Submit

November 12, 2024

Conditions

Keywords

Total Knee ArthroplastyAdductor Canal BlockIpack blockGenicular nerve blockPost-Operative PainPeripheral Nerve Block

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Examination with Numeric Rating Scale

    Determination of patients' post-operative pain level. The Numeric Rating Scale (NRS), a method that converts the patient's pain perception into a numerical form, will be used to assess postoperative pain. NRS has a numerical scale ranging from 0 to 10. The patient will rate the intensity of pain on a scale from 0, indicating no pain, to 10, representing the worst imaginable pain (NRS 0=no pain, 4=mild to moderate pain, 6-8=severe pain, and \>8=intolerable pain).

    48 hours

Study Arms (3)

Group Adductor canal block

ACTIVE COMPARATOR

Patients who underwent adductor canal block

Procedure: Group Adductor canal block

Group IPACK Block

ACTIVE COMPARATOR

Patients who underwent Infiltration between Popliteal Artery and Capsule of the Knee block

Procedure: Group IPACK Block

Group Genicular Nerve Block

ACTIVE COMPARATOR

Patients who underwent Genicular nerve block

Procedure: Group Genicular Nerve Block

Interventions

Adductor canal block procedure: The patient will be informed about the technique and consent will be obtained. The patient's hip will be slightly externally rotated, and an ultrasonography linear probe will be placed on the medial thigh, at the midpoint of the patella and vastus medialis. After locating the femoral artery at approximately 3-4 cm depth, if not visible, the artery can be traced distally from the inguinal region using Doppler mode. Once the vastus medialis and sartorius muscles are identified, the superficial femoral artery is centered at the midpoint of the sartorius muscle. The adductor canal roof, along with the saphenous and vastus medialis nerves, appears as hyperechoic structures. A needle is inserted in-plane, advancing toward the anterolateral femoral artery aspect, and 5-20 mL of LA is injected.

Group Adductor canal block

Genicular Nerve Block: The patient is informed and consent is obtained. With a pillow in the popliteal fossa, the knee is slightly flexed. For the superior lateral genicular nerve, a linear USG probe is positioned on the lateral femoral epicondyle, moving proximally to visualize the bone metaphysis. The superolateral artery is seen between the vastus lateralis fascia and the femur. Using in-plane or out-of-plane technique, the needle is guided to the bone, and 4-5 mL of LA is injected. For the superior medial nerve, the probe is placed on the medial epicondyle and moved proximally to visualize the bone near the adductor tubercle. The artery lies between the femur and vastus medialis fascia. For the inferomedial artery, the probe is placed on the tibial medial condyle, moving distally. A negative aspiration test is conducted before each LA injection.

Group Genicular Nerve Block

IPACK Block: Before the procedure, the patient is informed about the technique and written consent is obtained from the patient. The patient lies in the prone position. The linear USG probe is placed approximately 2-3 cm above the popliteal fossa and scanned distally to identify the femoral shaft and popliteal artery. If the femoral condyles are initially visualized, the probe is moved until the condyles disappear and the femoral shaft is identified as a straight line and hyperechoic. Color doppler can be used to identify the popliteal vessels. The peripheral block needle is advanced between the femoral shaft and the popliteal artery. After negative aspiration control, 15-20 mL of LA medication is injected here.

Group IPACK Block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II-III
  • BMI \< 40
  • years old

You may not qualify if:

  • ASA IV-V
  • \<18 years, \>80 years
  • Will undergo revision TKA surgery
  • Will undergo bilateral TKA surgery
  • BMI \> 40
  • Patients who used high dose opioid medication within 3 days before surgery
  • those with widespread chronic pain, diabetes mellitus, a history of neuromuscular disease, hepatic and renal failure
  • who underwent general anesthesia during the intraoperative period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hitit University Erol Olcok Training and Research Hospital

Çorum, 19200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Group A (n=30): Patients who underwent adductor canal block , group I (n=30): Patients who underwent infiltration block between popliteal artery and knee capsule block, group G (n=30): Patients who underwentgenicular nerve block
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 7, 2024

First Posted

November 13, 2024

Study Start

October 1, 2022

Primary Completion

February 1, 2023

Study Completion

April 15, 2023

Last Updated

November 13, 2024

Record last verified: 2024-11

Locations