Pericapsular Nerve Group Block Versus Intrathecal Morphine for Analgesia After Total Hip Arthroplasty

Официальное название

Comparison of the Efficacy of the Pericapsular Nerve Group (PENG) Block Versus Intrathecal Morphine for Postoperative Analgesia Following Total Hip Arthroplasty

Обзор

The Pericapsular Nerve Group (PENG) block is an effective method for postoperative pain management in patients undergoing primary total hip arthroplasty (THA) via a posterolateral approach. The application of this technique reduces postoperative opioid requirements, thereby limiting the risk of adverse effects associated with systemic opioid administration. Effective pain control and a reduced incidence of side effects may translate into higher patient satisfaction and a decreased length of hospital stay (LOS). The PENG block serves as an effective component of multimodal analgesia and may provide an alternative to intrathecal morphine in patients undergoing primary total hip arthroplasty via a posterolateral approach, where the primary anesthetic technique is spinal anesthesia with hyperbaric bupivacaine. Objectives 1. To evaluate the efficacy of the PENG block in postoperative pain control and compare its effectiveness with intrathecal morphine administration. 2. To assess the impact of the PENG block on postoperative opioid consumption in comparison to analgesia achieved via intrathecal morphine. 3. To analyze the incidence of selected adverse effects associated with systemic opioid administration in patients receiving a PENG block versus those in the intrathecal morphine group. 4. To evaluate patient satisfaction levels regarding postoperative pain management across the different analgesic modalities. 5. To analyze the correlation between the type of analgesia employed and the duration of hospitalization.

Вмешательства

• Процедура PNEG block
  Pericapsular Nerve Group (PENG) block will be performed using 20 mL of 0.5% ropivacaine (Ropimol, Molteni, Italy), supplemented with 4 mg of dexamethasone (Dexaven, Bausch Health, Ireland).
• Процедура Spinal anesthesia with opioid
  Spinal anesthesia will be administered using 0.5% hyperbaric bupivacaine, supplemented with 100 mcg of morphine (Morphini Sulfas WZF 0.1% Spinal, Polpharma, Poland).
• Процедура Spinal anesthesia without opioid
  Spinal anesthesia will be administered using 0.5% hyperbaric bupivacaine (Marcaine Spinal 0.5% Heavy, Aspen Pharma, Ireland).
• Процедура Sham PENG block
  A sham PENG block will be performed using 20 mL of 0.9% sodium chloride solution (Natrium chloratum 0,9% Fresenius, Fresenius Kabi, Poland).

Первичные конечные точки

• Cumulative oxycodone consumption delivered via patient-controlled analgesia (PCA) [Срок оценки: From end of surgery to 24 hours postoperatively.]
• Number of patient-initiated PCA demand attempts recorded by the PCA pump [Срок оценки: From end of surgery to 24 hours postoperatively.]
• Pain intensity at rest measured by the 11-point Numerical Rating Scale (NRS, 0-10) [Срок оценки: Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.]
• Dynamic pain assesmnetDynamic pain intensity during passive straight leg raise measured by the 11-point Numerical Rating Scale (NRS, 0-10) [Срок оценки: Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.]
• Patient satisfaction with postoperative analgesia measured by a 5-point Likert satisfaction scale (1-5) [Срок оценки: At 0, 4, 8, 12, and 24 hours after surgery.]

Вторичные конечные точки (12)

• Nausea severity [Срок оценки: Assessed on the day before surgery and at 0, 4, 8, 12, and 24 hours postoperatively]
• Pruritus Severity [Срок оценки: Assessed on the day before surgery and at 0, 4, 8, 12, and 24 hours postoperatively]
• Postoperative length of hospital stay (days) [Срок оценки: From hospital admission to hospital discharge (assessed at hospital discharge).]
• Sedation and agitation level measured by the Richmond Agitation-Sedation Scale (RASS, -5 to +4) [Срок оценки: At 0, 4, 8, 12, and 24 hours after surgery.]
• Motor blockade measured by the Bromage motor blockade scale (Grade 0-3) [Срок оценки: At 0, 4, 8, 12, and 24 hours after surgery.]
• Sensory blockade [Срок оценки: At 0, 4, 8, 12, and 24 hours postoperatively.]
• Antiemetic Consumption [Срок оценки: Within the first 24 hours following the completion of surgery]
• Intraoperative blood loss (mL) [Срок оценки: Intraoperatively (from skin incision to skin closure).]
• Duration of surgery (minutes) [Срок оценки: Intraoperatively (from skin incision to skin closure).]
• Participants requiring intraoperative vasopressors [Срок оценки: Intraoperatively (from skin incision to skin closure).]
• Heart rate (beats per minute) [Срок оценки: Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.]
• Peripheral oxygen saturation (SpO2, %) [Срок оценки: Baseline (day before surgery), and at 0, 4, 8, 12, and 24 hours after surgery.]

Критерии участия

Критерии включения

• Informed, written consent for study participation.
• Qualification for elective primary total hip arthroplasty via a posterolateral approach.
• Age above 18 years.
• ASA Physical Status I-III.
• Absence of contraindications to spinal anesthesia.
• Absence of contraindications to performing a Pericapsular Nerve Group (PENG) block.
• Absence of contraindications to the administration of the pharmacological agents utilized in the study.

Критерии исключения

• Absence of informed consent.
• Age below 18 years.
• Psychoactive substance abuse or dependence.
• Chronic opioid therapy.
• Contraindications to spinal anesthesia.
• Contraindications to the Pericapsular Nerve Group (PENG) block.
• Contraindications to the administration of study medications.
• Body Mass Index (BMI) above 30 kg/m\^2.
• Pregnancy.
• History of chronic pain management.

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: NCT07449585 · GRU/KAZ/1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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