PENG Block With or Without PPD Block for Postoperative Analgesia After Total Hip Arthroplasty

Официальное название

Comparison of the Efficacy of Pericapsular Nerve Group (PENG) Block Versus PENG Block Added to Posterior Pericapsular Deep Gluteal (PPD) Block for Postoperative Analgesia in Total Hip Arthroplasty

Обзор

This single-center, prospective, randomized controlled clinical trial aims to compare the postoperative analgesic efficacy of PENG block with or without posterior pericapsular deep gluteal block in adult patients undergoing elective primary total hip arthroplasty under spinal anesthesia. Total hip arthroplasty is commonly associated with moderate to severe postoperative pain. Although PENG block provides analgesia for the anterior hip capsule, some patients may still experience pain originating from the posterior capsule. The addition of PPD block may improve analgesia by targeting posterior articular branches. Participants will be randomized into two groups: one group will receive PENG block, and the other group will receive PENG plus PPD block. Postoperative pain will be assessed using the Numeric Rating Scale (NRS). The study will compare postoperative pain scores and other analgesia-related outcomes between groups.

Подробное описание

This study is planned as a single-center, prospective, randomized, controlled, double-blind trial in adult patients undergoing elective primary total hip arthroplasty under spinal anesthesia. Eligible participants will be patients aged 18 years or older, classified as ASA physical status I-III, and able to provide informed consent. Patients with ASA IV-V, serious cardiac, respiratory, hepatic, or renal disease, neuropsychiatric disorders, cognitive impairment preventing reliable NRS assessment, coagulopathy, local anesthetic allergy, infection or scar at the block site, failed block, signs of local anesthetic systemic toxicity, exposure to local anesthetic doses above protocol limits, revision total hip arthroplasty, fracture-related total hip arthroplasty, or refusal to participate will be excluded. Participants will be randomized by sealed-envelope method into two groups. Group 1 will receive PENG block after spinal anesthesia in the supine position using ultrasound guidance and 20 mL of 0.25% bupivacaine. Group 2 will receive PENG block followed by ultrasound-guided PPD block, with 30 mL of 0.25% bupivacaine used for the PPD block. In addition, both groups will receive lateral femoral cutaneous nerve block with 5 mL of 0.25% bupivacaine. The primary objective is to compare postoperative pain intensity between groups using Numeric Rating Scale scores. Secondary evaluations include postoperative analgesic consumption, time to first rescue analgesia, time to first mobilization, and motor function including ankle dorsiflexion strength. An initial pilot phase including 40 patients is planned, and the final sample size will be calculated using G\*Power based on pilot data with alpha 0.05 and power 0.80. The study will continue until the target sample size is reached.

Вмешательства

• Процедура PENG Block
  Ultrasound-guided pericapsular nerve group block performed after spinal anesthesia for postoperative analgesia in patients undergoing primary total hip arthroplasty. In Group 1, PENG block will be performed in the supine position using an in-plane technique, and 20 mL of 0.25% bupivacaine will be injected between the psoas tendon and iliopubic ramus. In both groups, lateral femoral cutaneous nerve block will also be performed as part of the analgesic protocol.
• Процедура Deep posterior gluteal compartment block
  Ultrasound-guided posterior pericapsular deep gluteal block performed after PENG block and spinal anesthesia for postoperative analgesia in patients undergoing primary total hip arthroplasty. In Group 2, the block will be performed in the lateral decubitus position with the hip and knee flexed to 90 degrees, and 30 mL of 0.25% bupivacaine will be injected after needle placement to the posterior acetabular rim near the ischiofemoral ligament using an in-plane technique.

Первичные конечные точки

• Postoperative pain intensity at 6 hours measured by Numeric Rating Scale (NRS) [Срок оценки: 6 hours after surgery]

Вторичные конечные точки (5)

• Postoperative pain intensity over the first 24 hours measured by Numeric Rating Scale (NRS) [Срок оценки: Recovery room, 2 hours, 12 hours, and 24 hours after surgery]
• Total analgesic consumption during the first 24 hours [Срок оценки: 24 hours after surgery]
• Time to first rescue analgesic requirement [Срок оценки: Up to 24 hours after surgery]
• Time to first mobilization [Срок оценки: Up to 24 hours after surgery]
• Ankle dorsiflexion motor strength [Срок оценки: Recovery room, 2 hours, 6 hours, 12 hours, and 24 hours after surgery]

Критерии участия

Критерии включения

• Adults aged 18 years and older
• American Society of Anesthesiologists (ASA) physical status I-III
• Scheduled for elective primary total hip arthroplasty under spinal anesthesia
• Able to provide written informed consent

Критерии исключения

• ASA physical status IV or V
• Serious concomitant cardiac, respiratory, hepatic, or renal disease
• Known neuropsychiatric disorder
• Cognitive impairment preventing understanding or response to the Numeric Rating Scale (NRS)
• Coagulopathy
• Local anesthetic allergy
• Infection or scar at the block site
• Failed block
• Refusal to participate
• Signs of local anesthetic systemic toxicity after block
• Patients in the PENG plus PPD group who would be exposed to a total local anesthetic dose above 3 mg/kg in patients weighing less than 50 kg
• Revision total hip arthroplasty
• Total hip arthroplasty planned for fracture

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07502248 · KAEAH-THA-PENG-PPD-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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