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

NCT07092982 — Not applicable, Recruiting, 52 participants, SB Istanbul Education and Research Hospital

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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

Registry	NCT07092982
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	52 (Estimated)
Sponsor	SB Istanbul Education and Research Hospital (Other)
Conditions	Total Knee Arthroplasty, Ultrasound Guided Supra-inguinal Fascia Iliaca Block, Adductor Canal Block
Interventions	Ultrasound Guided Suprainguinal Fascia Iliaca Block, Ultrasound Guided Adductor Canal Block, Ultrasound Guided iPACK Block (Procedure)
Dates	start 2025-08-04, primary completion 2026-07-01 (estimated), completion 2026-07-01 (estimated), first posted 2025-07-30, last updated 2026-04-06
Locations	1 site in Turkey (Türkiye)

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Ultrasound Guided Fascia Iliaca Block	Active comparator	Procedure: Ultrasound Guided Suprainguinal Fascia Iliaca Block	Suprainguinal fascia iliaca block was applied to the patients in this group at the end of the operation.
Ultrasound Guided Adductor Canal Block + iPACK Block	Active comparator	Procedure: Ultrasound Guided Adductor Canal Block; Procedure: Ultrasound Guided iPACK Block	Adductor Canal Block and iPACK Block was applied to the patients in this group at the end of the operation.

Ultrasound Guided Suprainguinal Fascia Iliaca Block (Procedure): Ultrasound Guided Suprainguinal Fascia Iliaca Block, 30 ml Bupivacain %0,25
Ultrasound Guided Adductor Canal Block (Procedure): Ultrasound Guided Adductor Canal Block, 15ml Bupivacain %0,25
Ultrasound Guided iPACK Block (Procedure): Ultrasound Guided iPACK Block, 15ml Bupivacain %0,25

+Outcome measures

Primary outcomes

Cumulative opioid consumption [24 hours]: Tramadol consumption will be recorded for 24 hours.

Secondary outcomes

Numeric rating scale for pain [Up to 24 hours]: Variations 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.
Time to first postoperative analgesic requirement [Up to 24 hours]: The time to first postoperative analgesic requirement was recorded.
Postoperative quadriceps muscle strength [Up to 24 hours]: Muscle 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.
Incidence of postoperative nausea and vomiting [Up to 24 hours]: Opioid side effects were recorded.
Quality of Recovery 15 (QoR-15) [24 hours]: The 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 levels [Up to 24 hours]: The 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.

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
SB Istanbul Education and Research Hospital	Istanbul	Turkey (Türkiye)	Recruiting