Recruiting NCT07453498
Evaluating the Efficacy of the Psoas Sheath Block for Post Operative Analgesia Following Hip Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psoas Sheath Block, Suprainguinal Fascia Iliaca.
- Who it may be relevant to
- Registry conditions: Total Hip Arthroplasty (THA). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Procedure 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 - Procedure 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
Primary outcome measures
- Quality of recovery 15 score [Time frame: the first 48 hours post-operatively]
- Total oral morphine equivalents at 24 hours [Time frame: First 24 hours postoperatively]
Secondary outcome measures (6)
- Numerical rating scale (NRS) for pain at rest and movement at 2, 4, 6, and 24 hours postoperatively. [Time frame: First 24 hours post-operatively]
- Opioid consumption in morphine equivalents at 2, 4, 6, 12, 48 hours postoperatively. [Time frame: First 48 hours post-operatively]
- Cumulated ambulatory score (CAS) on postoperative day 1. [Time frame: first day post operatively]
- Distance mobilised on postoperative day 1. [Time frame: 1st day postoperatively]
- Patient satisfaction with pain management, assessed using a Likert scale on postoperative day 1. [Time frame: Post operative day 1]
- Opioid related side effects [Time frame: first 48 hours post operatively]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Ireland · 1 center
- Merlin Park Hospital, Galway — Galway
Identifiers
NCT: NCT07453498 · C.A.3190