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

NCT07453498 · tracked via the Priya Life Science Ireland tracker

Sponsor

University College Hospital Galway

Phase

Not applicable

Started

2025-11-18

Last updated

2026-03-06

Condition(s) studied

Total Hip Arthroplasty (THA)

Investigational drug(s) / intervention(s)

Psoas Sheath BlockSuprainguinal Fascia Iliaca

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 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

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 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.

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Quality of recovery 15 score — 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 — First 24 hours postoperatively
The total 24-hour oxycodone (and morphine-equivalent consumption) will be recorded, documenting all administered doses

Trial sites (1)

Facility	City	Region	Status
Merlin Park Hospital, Galway	Galway	Ireland	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07453498 on ClinicalTrials.gov ↗ ← All trials in Ireland