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NCT07904585
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
Conditions: Postoperative Pain, Hip Arthroplasty, Total
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Uludag University
Summary
This prospective, single-center, randomized controlled, double-blind (participant and outcomes assessor) trial compares ultrasound-guided erector spinae plane block (ESPB) and quadro-iliac plane block (QIPB) in adult patients undergoing elective primary unilateral total hip arthroplasty (THA) under spinal anesthesia. Eighty patients will be randomized 1:1 to receive either block in addition to a standardized multimodal analgesia protocol. The primary outcome is cumulative opioid consumption (intravenous morphine equivalents, mg) during the first 24 postoperative hours. Secondary outcomes include quality of recovery (QoR-15), pain scores, opioid consumption at later time points, quadriceps strength, mobilization, patient satisfaction, and safety outcomes. It is hypothesized that QIPB will reduce 24-hour opioid consumption more than ESPB.
Eligibility Criteria
Inclusion Criteria:
* Scheduled for elective primary unilateral total hip arthroplasty
* Provided written informed consent
* American Society of Anesthesiologists (ASA) physical status I, II or III
* Aged 18-80 years
* Scheduled to undergo surgery under spinal anesthesia
* Able to understand the information provided in Turkish and have the cognitive capacity to complete the QoR-15 questionnaire
Exclusion Criteria:
* Contraindication to regional anesthesia (coagulopathy, inappropriate anticoagulant use, infection at the injection site, etc.)
* History of known allergy or severe adverse reaction to local anesthetics
* Chronic opioid use, opioid dependence, or history of substance abuse
* Advanced cognitive impairment, inability to give valid consent, or inability to complete the questionnaires
* Pregnancy or breastfeeding
* Need for emergency surgery
* Surgical plan extending beyond unilateral primary total hip arthroplasty (THA)
* Presence of a severe systemic disease (severe neurological disease; advanced-stage hepatic, renal or cardiovascular failure) or clinical condition that may prevent adherence to the study protocol
* Body mass index (BMI) \> 35 kg/m²
* Contraindication or allergy to the multimodal analgesic agents specified in the protocol (paracetamol, NSAIDs, dexamethasone) or to morphine
* Regular gabapentinoid use or chronic pain syndrome
* Inability to use the patient-controlled analgesia (PCA) device
Source: ClinicalTrials.gov (NCT07904585). StuddyBuddy aggregates publicly available trial information.