AzTrials
AzTrials

Total Knee ArthroplastyNCT07324486

Postoperative Analgesic Efficacy Between Adductor Canal Block + IPACK Block and Adductor Canal Block + Genicular Nerve Block in Total Knee Arthroplasty

A study testing Adductor Canal Block (ACB) + iPACK Block and adductor canal block + genicular blocks in people with Total Knee Arthroplasty and Adductor Canal Block, run by Konya Beyhekim Training and Research Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The aim of this study is to compare the postoperative analgesic efficacy and functional outcomes of the IPACK+Adductor Canal Block with the Genicular Nerve Block+Adductor Canal Block block in patients undergoing total knee arthroplasty (TKA). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Adductor Canal Block (ACB) + iPACK Block and adductor canal block + genicular blocks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
15 Dec 2025to 1 Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients scheduled for spinal anesthesia with TDA.
  • Age ≥18.
  • American Society of Anesthesiologists (ASA) physical status score I-III.
  • Patients capable of providing informed consent.

Who cannot join

  • Active infection at the injection site.
  • Coagulopathy or systemic sepsis.
  • Severe hypovolemia.
  • Patients who refuse regional anesthesia.
  • Known allergy to local anesthetics.
  • Cognitive impairment or uncooperative patients.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Comparison of Functional Outcomes and Postoperative Analgesic Efficacy Between Adductor Canal Block + IPACK Block and Adductor Canal Block + Genicular Nerve Block in Patients Undergoing Total Knee Arthroplasty

The aim of this study is to compare the postoperative analgesic efficacy and functional outcomes of the IPACK+Adductor Canal Block with the Genicular Nerve Block+Adductor Canal Block block in patients undergoing total knee arthroplasty (TKA). The primary objective (measurable) is to evaluate functional improvement using 6-Clicks scores, while secondary objectives include pain scores (Vas Score), opioid consumption, hospital stay duration, and patient satisfaction (Patient Satisfaction Index).

IPACK : The infiltration between the popliteal artery and capsule of the knee

Read the detailed description

Group I: Patients who underwent IPACK + Adductor canal block after TDA surgery Group G: Patients who underwent Genicular nerve block + Adductor canal block after TDA surgery

This study will be designed as a prospective randomized trial, and randomization will be performed using the sealed envelope method. This method will be carried out as follows:

First, the study will include two groups: Group I (patients who received a block between the posterior knee capsule and the popliteal artery (IPACK) + adductor canal block (AKB)) and Group G (patients who received a genicular nerve block + adductor canal block). The number of subjects in each group will be adjusted to be equal.

Simple randomization: A list will be created to assign subjects to groups using software (e.g., the RANDBETWEEN function in Excel or an online randomization tool) or a random number table. Each participant will be assigned a serial number in the randomization list (e.g., from 1 to 100). Group Assignment: A group assignment is determined for each number in the randomization list. A random sequence number will be written on each envelope. A piece of paper containing the group assignment corresponding to the number will be placed inside the envelope (e.g., "Group I" or "Group G").

The envelopes will be securely sealed and sealed to prevent any crossover between groups. The prepared envelopes will be randomly mixed.

When each participant is included in the study, an envelope will be opened in sequence.

The participant will be assigned to the relevant group according to the information in the envelope. Since the study requires blinding, no one other than the person opening the envelope will know the group assignment. The envelopes will be prepared by a person not involved in the study.

They will be divided into Group I (IPACK+AKB) and Group G (GENIKÜLER+AKB); additionally, clinicians performing IPACK+AKB and Geniküler+AKB will not be involved in the postoperative data collection period. This research study will be limited to TDA surgeries. ASA 1-2-3 TDA surgeries performed in orthopedic operating rooms will be included.

Study Design According to randomization, all patients will undergo a standard spinal anesthesia protocol administered by anesthesiologists with at least 5 years of clinical experience who are blinded to the randomization.

This study will be designed as a prospective randomized study, and randomization will be performed using a sealed envelope method.

Patients will be divided into Group I (IPACK+AKB) and Group G (Genicular+AKB); additionally, clinicians performing IPACK+AKB and Genicular +AKB will not be included in the postoperative data collection period. This research study will be limited to TDA surgeries. ASA 1-2-3 risk patients will be included.

Standard monitoring procedures will be performed on all patients, including electrocardiography (ECG), peripheral oxygen saturation (SpO2), and noninvasive arterial blood pressure monitoring. Patients will be monitored according to ASA-defined criteria, and after vital signs are observed, the anesthesiologist will administer 1 mg of midazolam intravenously for sedation, followed by spinal anesthesia using a 25-gauge spinal needle and 12.5 mg of bupivacaine. Depending on randomization, the block will be performed according to the group after the surgery is completed. Information about the operation and the patient will be recorded perioperatively.

After postoperative monitoring, the patient will be positioned, and then, according to randomization, IPACK+AKB or Genicular+AKB will be performed with ultrasound guidance. For Group I, the linear probe will be placed with the patient in the supine position and the knee slightly flexed. The linear probe is placed in the transverse plane in the upper part of the popliteal region, where the popliteal artery is visible. The femoral condyles, popliteal artery, and target injection site (the space between the popliteal artery and the femur) are visualized with ultrasound. After ensuring sterile conditions, the needle is advanced laterally to medially, parallel to the ultrasound probe. After the needle tip is placed in the target area between the popliteal artery and the femur, the local anesthetic solution (10 ml of 0.5% bupivacaine + 10 ml of physiological saline) is slowly injected after negative aspiration. After completing the IPACK Block, a high-frequency linear probe is placed in the transverse plane in the middle of the thigh, in the area where the femoral artery can be palpated. The sartorius muscle, femoral artery, and structures within the adductor canal (such as the saphenous nerve) are identified on the ultrasound image. After ensuring sterile conditions, the needle is advanced laterally to medially, parallel to the ultrasound probe. After the needle tip is placed within the adductor canal, the local anesthetic solution (10 ml of 0.5% bupivacaine + 10 ml of physiological saline) is slowly injected after negative aspiration. This completes the AKB.

Patients in Group G are positioned supine with the knee slightly bent. The injection site is cleaned with an antiseptic solution and a sterile field is established. A high-frequency linear ultrasound probe is placed over the medial and lateral regions of the knee joint. The condyles of the femur and tibia, arteries, and areas where the genicular nerves pass are identified on the ultrasound image. Under sterile conditions, the block needle is advanced subcutaneously parallel to the ultrasound probe (in-plane technique). The tip of the needle is directed toward the superior lateral, superior medial, and inferior medial genicular nerves under ultrasound guidance. When the needle tip reaches the vicinity of the targeted nerve, negative aspiration is performed to ensure that it is not within a vessel. Subsequently, 2 ml of local anesthetic (0.5% bupivacaine) is injected into each nerve region. After all injections are completed, the needle is removed, and a sterile bandage is applied to the injection sites. After the genicular nerve block is completed, a high-frequency linear probe is placed in the transverse plane in the middle of the thigh, in the area where the femoral artery can be palpated. The sartorius muscle, femoral artery, and structures within the adductor canal (such as the saphenous nerve) are identified on the ultrasound image. After ensuring sterile conditions, the needle is advanced laterally to medially, parallel to the ultrasound probe. After the needle tip is placed into the adductor canal, the local anesthetic solution (10 ml of 0.5% bupivacaine + 10 ml of physiological saline) is slowly injected after negative aspiration. This completes the AKB.

The VAS score will be recorded in the postoperative recovery room at 30 minutes. After postoperative follow-up, patients will be sent to the ward. All patients in the ward will undergo VAS assessment (at 6, 12, 24, 36, 48, 60, and 72 hours), and intravenous paracetamol 15 mg/kg and intravenous diclofenac 1.5 mg/kg (maximum 75 mg) every 12 hours will be administered. If the VAS score is 4 or higher in the postoperative period, intravenous tramadol 1 mg/kg will be administered as rescue analgesia. This analgesia protocol is routinely applied by the Orthopedics clinic after total knee replacement surgeries; no additional analgesics specific to the study will be administered.

The primary outcome measure of the study is the 6-Clicks score, while the secondary outcome measures are the visual analog scale (VAS) score, total opioid consumption, patient satisfaction (Patient Satisfaction Index), and length of hospital stay.

The 6-Clicks score will be assessed at 6, 12, 24, 36, 48, 60, and 72 hours. The Visual Analog Scale (VAS) score will be recorded at 30 minutes in the postoperative recovery room and at 6, 12, 24, 36, 48, 60, and 72 hours. In addition, total opioid consumption in the first 24 hours, patient satisfaction (Patient Satisfaction Index), and length of hospital stay will also be recorded.

Demographic data (age, height, gender, weight), ASA physical score, and duration of surgery are other data that will be recorded.

Being tested
Adductor Canal Block (ACB) + iPACK Block, adductor canal block + genicular blocks
Keywords
total knee arthroplasty, adductor canal block, genicular nerves block, IPACK

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adductor Canal Block (ACB) + iPACK BlockDrug

    Patients who underwent total knee arthroplasty surgery with IPACK + adductor canal block , 25 patients. After the needle tip is placed in the target area between the popliteal artery and the femur, the local anesthetic solution (10 ml of 0.5% bupivacaine + 10 ml of physiological saline) is slowly injected after negative aspiration. After the needle tip is placed within the adductor canal, the local anesthetic solution (10 ml of 0.5% bupivacaine + 10 ml of physiological saline) is slowly injected after negative aspiration.

  • adductor canal block + genicular blocksDrug

    Patients who underwent total knee arthroplasty surgery with genicular blocks + adductor canal block , 25 patients. The tip of the needle is directed toward the superior lateral, superior medial, and inferior medial genicular nerves under ultrasound guidance.2 ml of local anesthetic (0.5% bupivacaine) is injected into each nerve region. After the needle tip is placed into the adductor canal, the local anesthetic solution (10 ml of 0.5% bupivacaine + 10 ml of physiological saline) is slowly injected after negative aspiration.

Study groups in NCT07324486
Study groupRoleWhat they receive
GROUP IPACKOtherADDUCTOR CANAL BLOCK + IPACK
Receives: Drug: Adductor Canal Block (ACB) + iPACK Block
GROUP GENİCULARExperimentalADDUCTOR CANAL BLOCK + GENİCULAR BLOCK
Receives: Drug: adductor canal block + genicular blocks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-Clicks score

    Known as "6-Clicks" due to being composed of six scored patient activity questions, a patient's "6-Clicks" score falls on a 6- to 24-point scale where a score of 6 represents total functional impairment and a score of 24 represents total absence of impairment.

    Measured: 6.,12.,24.,36.,48.,60.,72. hours

Secondary outcomes (3)
  1. visual analog scale

    The Visual Analogue Scale (VAS) is a psychometric instrument used in research and clinical studies to measure the intensity of subjective experiences that cannot be objectively quantified using defined biomarkers, such as pain, fatigue, or mood. It typically consists of a 100 mm straight line with descriptive anchors at each end representing the extremes of the sensation (for example, "no pain" at one end and "the most severe pain imaginable" at the other).

    Measured: Postoperative recovery room 30 minutes and at 6., 12., 24., 36., 48., 60., and 72. hours

  2. total opioid consumption

    total opioid consumption per day

    Measured: total opioid consumption 24.hour

  3. The Patient Satisfaction Index

    The Patient Satisfaction Index (PSI) was used to describe self-evaluation of the outcome and responseof 1 or 2 was considered to indicate a satisfying outcomeand 3 or 4 to indicate a dissatisfied outcome.

    Measured: first 24. hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2026
  2. Study start15 Dec 2025 (estimated)
  3. Primary completion30 Jan 2026 (estimated)
  4. Study completion1 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07324486
Sponsor's protocol ID
KonyaBeyhekimTRH2025/0115
Status last verified
Dec 2025
First submitted
10 Dec 2025
Last updated
7 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Adductor Canal Block (ACB) + iPACK Block and adductor canal block + genicular blocks in people with Total Knee Arthroplasty and Adductor Canal Block, run by Konya Beyhekim Training and Research Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sami Uyar, Dr (+905379869085, uyarsami111191@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-Clicks score (time frame: 6.,12.,24.,36.,48.,60.,72. hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in