Evaluating the Efficacy of the Psoas Sheath Block for Post Operative Analgesia Following Hip Arthroplasty

Обзор

This study will be a single-centre, assessor-blind, randomised controlled trial to compare the efficacy of the psoas sheath block (experimental group) with the suprainguinal fascia iliaca plane block (control group) in patients undergoing total hip arthroplasty Participants will be randomly assigned to one of two groups (psoas sheath block or Fascia Iliaca block) using a computer-generated random number sequence. The allocation will be concealed in opaque, sealed envelopes. The assessor will be blinded to the group allocation to ensure unbiased outcome assessment

Вмешательства

• Процедура Psoas Sheath Block
  Intervention group: Subpsoas Fascial Plane Block Participants in the subpsoas fascial plane block arm will receive a psoas sheath block preoperatively under direct ultrasound guidance as follows: Preparation: Standard skin sterilisation, prepping, and draping will be applied to the block area. Ultrasound Guidance: Anatomical landmarks will be identified using a curvilinear low-frequency (2-5 MHz) ultrasound probe. Local Anaesthetic Administration: A 22 G, 100mm needle will be inserted usi
• Процедура Suprainguinal Fascia Iliaca
  Fascia Iliaca Compartment Block Participants in the fascia iliaca compartment block arm will receive a fascia iliaca block preoperatively under direct ultrasound guidance as follows: Preparation: Standard skin sterilisation, prepping, and draping will be applied to the block area. Ultrasound Guidance: Anatomical landmarks will be identified using a linear high-frequency (6-13 MHz) ultrasound probe. Local Anaesthetic Administration: A 22 G, 50 mm needle will be inserted using the in-plane

Первичные конечные точки

• Quality of recovery 15 score [Срок оценки: the first 48 hours post-operatively]
• Total oral morphine equivalents at 24 hours [Срок оценки: First 24 hours postoperatively]

Вторичные конечные точки (6)

• Numerical rating scale (NRS) for pain at rest and movement at 2, 4, 6, and 24 hours postoperatively. [Срок оценки: First 24 hours post-operatively]
• Opioid consumption in morphine equivalents at 2, 4, 6, 12, 48 hours postoperatively. [Срок оценки: First 48 hours post-operatively]
• Cumulated ambulatory score (CAS) on postoperative day 1. [Срок оценки: first day post operatively]
• Distance mobilised on postoperative day 1. [Срок оценки: 1st day postoperatively]
• Patient satisfaction with pain management, assessed using a Likert scale on postoperative day 1. [Срок оценки: Post operative day 1]
• Opioid related side effects [Срок оценки: first 48 hours post operatively]

Критерии участия

Критерии включения

• Participants aged >18
• Patients scheduled to undergo elective unilateral total hip replacement (THR) surgery.
• Patients who agree to receive regional anaesthetic blocks as part of their post-operative pain management.
• Physical Status: ASA (American Society of Anesthesiologists) physical status classification I-III.
• Patients who are willing and able to provide informed consent, demonstrating an understanding of the trial's purpose, methods, and potential risks.
• Patients who are willing to comply with assessments post-surgery

Критерии исключения

• Allergy to Study Medications
• History of chronic opioid use (>50mg of oral morphine equivalents per day.
• Any neurological condition affecting the lower extremities (e.g., peripheral neuropathy, radiculopathy) that could interfere with pain assessment or recovery evaluation.
• Infection at Injection Site
• Coagulopathy or Anticoagulant Use: Patients with coagulopathy (INR >1.5) or who are on anticoagulant therapy that cannot be safely discontinued for the block procedure.
• Severe Respiratory or Cardiovascular Disease: Any severe respiratory or cardiovascular disease (e.g., severe chronic obstructive pulmonary disease, heart failure) that may increase perioperative risk and complicate recovery.
• Cognitive impairment or conditions (e.g., dementia with MMSE <24) that would prevent reliable pain reporting or compliance with post-operative assessments

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

Поддерживающая терапия

Центры проведения

Ирландия · 1 центр

• Merlin Park Hospital, Galway — Galway

Идентификаторы

NCT: NCT07453498 · C.A.3190

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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