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

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

Study Overview

• Status: Recruiting
• Conditions: Total Hip Arthroplasty (THA)
• Intervention / Treatment: Procedure: Psoas Sheath Block; Procedure: Suprainguinal Fascia Iliaca

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna L Horgan, MC BCh BAO FCAI; Phone Number: +353857848200; Email: annahorgan2@gmail.com

Study Locations

• Ireland
  • Galway, Ireland
    • Recruiting
    • Merlin Park Hospital, Galway
    • Contact: Anna L Horgan, MB BCh BAO FCAI; Phone Number: +353857848200; Email: annahorgan2@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 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
Active Comparator: 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.	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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of recovery 15 score	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	the first 48 hours post-operatively
Total oral morphine equivalents at 24 hours	The total 24-hour oxycodone (and morphine-equivalent consumption) will be recorded, documenting all administered doses	First 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical rating scale (NRS) for pain at rest and movement at 2, 4, 6, and 24 hours postoperatively.	This is a scale assessing patient reported pain from 0 to 10, with 10 being the most severe pain	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.	Cumulated ambulatory score is an assessment of mobility after hip arthroplasty that is rated from 0 to 6 with 6 being the highest degree of mobility	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.	A likert scale is a 5 point scale where 1 is very unsatisfied, 2 is satisfied, 3 is neutral, 4 is satisfied and 5 is very satisfied	Post operative day 1
Opioid related side effects	Measured using the opioid related symptom distress scale, is measures patient reported levels of opioid related side effects on a scale of 0 to 32, with 0 being no side effects and 32 indicating the highest level of opioid related side effects and distress	first 48 hours post operatively

Collaborators and Investigators

• Sponsor: University College Hospital Galway

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2025
• Primary Completion (Estimated): November 18, 2027
• Study Completion (Estimated): November 18, 2027

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Total Hip Arthroplasty; Regional anaesthesia; Psoas Sheath Block
• Other Study ID Numbers: C.A.3190

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No