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Clinical Trials/NCT07092982
NCT07092982RecruitingNot Applicable

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

SB Istanbul Education and Research Hospital2 sites in 2 countries52 target enrollmentStarted: August 4, 2025Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
52
Locations
2
Primary Endpoint
Cumulative opioid consumption

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Ultrasound Guided Fascia Iliaca Block

Active Comparator

Suprainguinal fascia iliaca block was applied to the patients in this group at the end of the operation.

Intervention: Ultrasound Guided Suprainguinal Fascia Iliaca Block (Procedure)

Ultrasound Guided Adductor Canal Block + iPACK Block

Active Comparator

Adductor Canal Block and iPACK Block was applied to the patients in this group at the end of the operation.

Intervention: Ultrasound Guided Adductor Canal Block (Procedure)

Ultrasound Guided Adductor Canal Block + iPACK Block

Active Comparator

Adductor Canal Block and iPACK Block was applied to the patients in this group at the end of the operation.

Intervention: Ultrasound Guided iPACK Block (Procedure)

Outcomes

Primary Outcomes

Cumulative opioid consumption

Time Frame: 24 hours

Tramadol consumption will be recorded for 24 hours.

Secondary Outcomes

  • Numeric rating scale for pain(Up to 24 hours)
  • Postoperative quadriceps muscle strength(Up to 24 hours)
  • Quality of Recovery 15 (QoR-15)(24 hours)
  • Inflammatory marker levels(Up to 24 hours)
  • Time to first postoperative analgesic requirement(Up to 24 hours)
  • Incidence of postoperative nausea and vomiting(Up to 24 hours)

Investigators

Sponsor
SB Istanbul Education and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kubilay Ekinci

Anesthesiology and Reanimation Resident

SB Istanbul Education and Research Hospital

Study Sites (2)

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