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Comparison of Two Different Regional Anesthetic Methods in Total Knee Arthroplasty Patients

Comparison of the Effects of Ultrasound-Guided Adductor Canal Block With iPACK (Space Between the Popliteal Artery and the Posterior Knee Capsule) Block Combination and Suprainguinal Fascia Iliaca Block on Postoperative Pain and Stress Response in Patients Undergoing Total Knee Arthroplasty

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07092982
Enrollment
52
Registered
2025-07-30
Start date
2025-08-04
Completion date
2026-04-30
Last updated
2025-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthroplasty, Ultrasound Guided Supra-inguinal Fascia Iliaca Block, Adductor Canal Block

Brief summary

Total Knee Arthroplasty patients are among the orthopedic cases that experience severe postoperative pain. In these cases, pain must be controlled. If pain is not controlled, early mobilization cannot be achieved. This can result in delayed physical therapy, prolonged hospital stays, the development of nosocomial infections, and impaired cognitive function. All of these factors contribute to increased patient care costs. Multimodal analgesia methods are used to control this pain. One of these methods is peripheral nerve blocks. Peripheral nerve blocks provide pain control and reduce the likelihood of opioid use and related side effects such as nausea, vomiting, and constipation. Current studies recommend Adductor Canal Blocks and iPACK (space between the popliteal artery and the posterior knee capsule) blocks for Total Knee Arthroplasty patients. In addition, studies are also being conducted on the application of the Suprainguinal Fascia-Iliaca Block in Total Knee Arthroplasty patients. The differences in postoperative analgesic effects between these methods are a matter of interest. No study has been conducted comparing the effects of these two approaches, which are routinely applied in our clinic and comply with guidelines, on the postoperative stress response. Regional anesthesia provides adequate pain control and has a positive effect on the stress response. The investigators aim to see a similar effect in peripheral nerve blocks. Therefore, comparing the methods that mentioned will contribute to the literature. In this study, the effects of these two different approaches on postoperative stress response and analgesic efficacy will be compared in terms of patients' postoperative opioid consumption, pain at rest and with movement, time to first analgesic need and development of motor block. IL-6 and CRP values will be examined pre-operatively and post-operatively to measure the effects on the stress response.

Interventions

Ultrasound Guided Suprainguinal Fascia Iliaca Block, 30 ml Bupivacain %0,25

Ultrasound Guided Adductor Canal Block, 15ml Bupivacain %0,25

PROCEDUREUltrasound Guided iPACK Block

Ultrasound Guided iPACK Block, 15ml Bupivacain %0,25

Sponsors

SB Istanbul Education and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing total knee arthroplasty * Patients aged 18-75 * Patients with ASA I-II-III

Exclusion criteria

* Coagulation disorders * Allergy to local anesthetics * Liver and renal failure * Alcohol and drug addiction * Cognitive dysfunction that may prevent pain assessment * Systemic or needle insertion site infection * Analgesic use for more than 3 months * Patient refusal to participate in the study/refusal to consent * Presence of a hematoma, hernia, neoplasm, etc. in the area where the block will be performed * Pre-existing neurological deficit * Patients with contraindications to nerve block

Design outcomes

Primary

MeasureTime frameDescription
Cumulative opioid consumption24 hoursTramadol consumption will be recorded for 24 hours.

Secondary

MeasureTime frameDescription
Time to first postoperative analgesic requirementUp to 24 hoursThe time to first postoperative analgesic requirement was recorded.
Postoperative quadriceps muscle strengthUp to 24 hoursMuscle strength assessment will be performed using the Modified Bromage Scale. (End of the surgery, Post-operative 6th, 12th and 24th hour) Grade 0: No motor block; the patient is able to fully flex the hip and knee. Grade 1: Partial motor block; the patient is able to move the knee and foot but is unable to lift the extended leg. Grade 2: Nearly complete motor block; the patient is unable to flex the knee and can only move the foot. Grade 3: Complete motor block; the patient is unable to move the ankle or the great toe.
Numeric rating scale for painUp to 24 hoursVariations in the Numeric Rating Scale (NRS) scores, both at rest and during movement, will be documented at specific time points (End of the surgery, Post-operative 6th, 12th and 24th hour). The NRS is a simple, single-dimensional tool used to assess pain intensity in adult patients. It is a numeric adaptation of the Visual Analog Scale (VAS), where individuals are asked to choose an integer between 0 and 10 that best represents their pain level. A score of '0' corresponds to no pain, while '10' indicates the worst imaginable pain or pain as severe as possible.
Quality of Recovery 15 (QoR-15)24 hoursThe influence of surgical and anesthetic interventions on perioperative quality of life and the patient's ability to return to routine daily activities will be systematically evaluated. QoR-15 has 15 questions. Each question is answered on a scale of 1 to 10. A higher score indicates more positive outcomes.
Inflammatory marker levelsUp to 24 hoursThe levels of inflammatory biomarkers (interleukin-6, CRP, NLR \[Neutrophil-Lymphocyte Ratio\], PLR \[Platelet-Lymphocyte Ratio\]) will be assessed prior to surgery and at 24 hours postoperatively.
Incidence of postoperative nausea and vomitingUp to 24 hoursOpioid side effects were recorded.

Countries

Turkey (Türkiye)

Contacts

Primary ContactKubilay Ekinci, MD
kubilay.ekinci@sbu.edu.tr0905062671972

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026