Evaluating the Efficacy of the Psoas Sheath Block for Post Operative Analgesia Following Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Quality of recovery 15 score
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention Group (Psoas Sheath Block)
Intervention group: Psoas sheath Block
Participants in the psoas sheath 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 using the in-plane technique and advanced to the target site.
A bolus of 40 ml of 0.375% ropivacaine will be injected into the subpsoas fascial plane.
The procedure will be performed by experienced anaesthesiologists to ensure accuracy and safety.
干预措施: Psoas Sheath Block (Procedure)
Control Group (Suprainguinal Fascia Iliaca Block)
Control group: 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 technique and advanced beneath the fascia iliaca.
A bolus of 40 ml of 0.375% ropivacaine will be injected into the fascia iliaca compartment.
The procedure will be performed by experienced anaesthesiologists to ensure accuracy and safety.
Dose adjustments will be made if the patient weighs <50kg to reduce the risk of local anaesthetic systemic toxicity.
干预措施: Suprainguinal Fascia Iliaca (Procedure)
结局指标
主要结局
Quality of recovery 15 score
时间窗: the first 48 hours post-operatively
Quality of Recovery 15 (QOR 15) score is a patient reported score used to assess quality of recovery after surgery. The lowest value is 0 and the highest is 150. The higher value signifies better recovery. It will be administered to patients pre-operatively to establish a baseline and then repeated at 24 and 48 hours to assess recovery status
Total oral morphine equivalents at 24 hours
时间窗: First 24 hours postoperatively
The total 24-hour oxycodone (and morphine-equivalent consumption) will be recorded, documenting all administered doses
次要结局
- Numerical rating scale (NRS) for pain at rest and movement at 2, 4, 6, and 24 hours postoperatively.(First 24 hours post-operatively)
- Opioid consumption in morphine equivalents at 2, 4, 6, 12, 48 hours postoperatively.(First 48 hours post-operatively)
- Cumulated ambulatory score (CAS) on postoperative day 1.(first day post operatively)
- Distance mobilised on postoperative day 1.(1st day postoperatively)
- Patient satisfaction with pain management, assessed using a Likert scale on postoperative day 1.(Post operative day 1)
- Opioid related side effects(first 48 hours post operatively)
研究者
John Laffey
Professor John Laffey MD, DSc
University College Hospital Galway