Comparison of Pericapsular Nerve Group (PENG) Block With a Combined Femoral, Sciatic, Lateral Femoral Cutaneous Nerve Block for Postoperative Analgesia in Secondary Total Hip Arthroplasty; (REVPET)

Официальное название

Comparison of Pericapsular Nerve Group (PENG) Block With a Combined Femoral, Sciatic, Lateral Femoral Cutaneous Nerve Block for Postoperative Analgesia in Secondary Total Hip Arthroplasty.

Обзор

The aim of this clinical trial is to compare the analgesic effect of a pericapsular nerve group (PENG) block with a combined femoral, sciatic, lateral femoral cutaneous nerve block for postoperative analgesia in patients scheduled for secondary total hip arthroplasty. The primary objective of this study is to compare postoperative pain management between the PENG block and the combined block (femoral, sciatic, lateral femoral cutaneous) by measuring postoperative morphine consumption in each of the two groups. Participants will be randomized into two groups. Patients assigned to the PENG group will receive a PENG block with ropivacaine, followed by a sham (sciatic) block, and spinal anesthesia with isobaric bupivacaine. Patients assigned to the combined block group will receive femoral, sciatic, lateral femoral cutaneous nerve blocks with ropivacaine, followed by spinal anesthesia with isobaric bupivacaine.

Подробное описание

This is a single-center, prospective, superiority, randomized, double-blind, parallel-group study.

Patients will be randomized into two groups of 25 patients each, for a total enrollment plan of 50 patients. After written informed consent, patients will be allocated to one of the two groups according to a computer-generated randomization list.

The nerve blocks will be performed using ultrasound guidance.

During the surgery, 0.15 mg/kg of dexamethasone IV, 1 g paracetamol IV, 30 mg ketorolac IV, and 40 mg/kg magnesium IV will be given for postoperative analgesia.

In the PACU, pain management will be provided as needed with 2 mg of IV morphine at ten-minute intervals for pain scores \>4. Once spinal motor block has resolved, the patients will be transferred to the surgical ward with a morphine patient-controlled analgesia (PCA) pump. The pump parameters will allow 2 mg boluses of morphine with a 10-minute lockout and a maximum dose of 40 mg in 4 hours.

Basal analgesia will be provided with paracetamol (1 g/6 h) and ibuprofen (400 mg/8 h). Ondansetron (4 mg IV) will be administered in case of nausea or vomiting.

A research assistant will conduct postoperative visits at 2 hours, 1 day, and 2 days postoperatively to record research data. Functional testing will be done on days 1 and 2 by physiotherapy personnel.

Вмешательства

• Препарат Pericapsular nerve group (PENG) block with 0.75% ropivacaine guided by ultrasound
  Participants in the PENG group will first receive a sham sciatic injection; the needle will be inserted into the subcutaneous tissue and 3 ml of 0.9% NaCl will be injected. They will then receive a PENG nerve block in the supine position. A low-frequency (2-5 MHz) curvilinear ultrasound probe (BK Ultrasound) will be used to identify the anterior inferior iliac spine, the pubic eminence, and the psoas tendon with its fascial plane. A 22-gauge, 50 mm needle (SonoPlex® Pajunk) will be inserted into
• Препарат Femoral, sciatic and lateral femoral cutaneous nerve block with 0.375% ropivacaine
  Participants in the combined group will first receive a sciatic nerve block performed with the patient in a semi-prone position, the lower limb flexed at 90° (hip and knee), elevated with a cushion placed between the legs. A straight line will be drawn between the greater trochanter and the ischial tuberosity. The sciatic nerve is located approximately at the midpoint of this line. Under ultrasound guidance, the ischial tuberosity will be identified medially, the greater trochanter laterally, th

Первичные конечные точки

• Cumulative postoperative morphine consumption at day 1 [Срок оценки: Time Frame: 24 hours postoperatively]

Вторичные конечные точки (9)

• Morphine consumption in the recovery room [Срок оценки: from admission till discharge from the recovery room, up to 2 hours]
• PCA administered morphine consumption at day 2 [Срок оценки: at day 2 postoperatively]
• Rest and dynamic pain scores [Срок оценки: At 2 hours, day 1 and day 2 postoperatively]
• Incidence of postoperative nausea and vomiting [Срок оценки: at 2 hours, day 1 and day 2 postoperatively]
• Incidence of pruritus [Срок оценки: at 2 hours, day 1 and day 2 postoperatively]
• Incidence of urinary retention requiring bladder catheterisation [Срок оценки: from surgery till day 2 postoperatively]
• Duration of analgesia [Срок оценки: from the time the study procedure is performed up to 36 hours after surgery]
• Operated limb quadriceps strength [Срок оценки: At day 1 and day 2 postoperatively]
• Walking test [Срок оценки: At day 1 and 2 postoperatively]

Критерии участия

Критерии включения

• Male and female patients
• ASA (American Society of Anaesthesiologists) I-III
• 18 years of age or older
• Patients scheduled for elective secundary hip arthroplasty
• Able to give written conformed consent autonomously

Критерии исключения

• Refusal or inability to give consent
• Allergy to any of: ropivacaine, paracetamol, ibuprofen, ketorolac, morphine, ondansetron or dexamethasone
• Bleeding diathesis
• Neurological deficit of the operative side
• Existing preoperative opioid use
• Renal insufficiency (GFR<30ml/min according to the Cockroft-Gault formula)
• Hepatic insufficiency
• Morbid Obésity III

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• She C, Liu H. The efficacy of pericapsular nerve group block for reducing pain and opioid consumption after total hip arthroplasty: a systematic review and meta-analysis. J Orthop Surg Res. 2024 Apr 8;19(1):229. doi: 10.1186/s13018-024-04707-x. PMID 38584259
• Newman JT, Briggs KK, McNamara SC, Philippon MJ. Outcomes After Revision Hip Arthroscopic Surgery in Adolescent Patients Compared With a Matched Cohort Undergoing Primary Arthroscopic Surgery. Am J Sports Med. 2016 Dec;44(12):3063-3069. doi: 10.1177/0363546516659656. Epub 2016 Aug 11. PMID 27514736
• Bohl DD, Samuel AM, Basques BA, Della Valle CJ, Levine BR, Grauer JN. How Much Do Adverse Event Rates Differ Between Primary and Revision Total Joint Arthroplasty? J Arthroplasty. 2016 Mar;31(3):596-602. doi: 10.1016/j.arth.2015.09.033. Epub 2015 Sep 28. PMID 26507527
• Mahomed NN, Barrett JA, Katz JN, Phillips CB, Losina E, Lew RA, Guadagnoli E, Harris WH, Poss R, Baron JA. Rates and outcomes of primary and revision total hip replacement in the United States medicare population. J Bone Joint Surg Am. 2003 Jan;85(1):27-32. doi: 10.2106/00004623-200301000-00005. PMID 12533568
• Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222. PMID 17403800
• Schwartz AM, Farley KX, Guild GN, Bradbury TL Jr. Projections and Epidemiology of Revision Hip and Knee Arthroplasty in the United States to 2030. J Arthroplasty. 2020 Jun;35(6S):S79-S85. doi: 10.1016/j.arth.2020.02.030. Epub 2020 Feb 19. PMID 32151524

Идентификаторы

NCT: NCT07109388 · 2025-00488

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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