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

NCT07453498 | Recruiting

• 1 other identifier: C.A.3190
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Total Hip Arthroplasty (THA)

Keywords

Total Hip Arthroplasty; Psoas Sheath Block; Regional anaesthesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (2)

Intervention Group (Psoas Sheath Block)

EXPERIMENTAL

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

Control Group (Suprainguinal Fascia Iliaca Block)

ACTIVE COMPARATOR

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

Interventions

Psoas Sheath Block PROCEDURE

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

Intervention Group (Psoas Sheath Block)

Suprainguinal Fascia Iliaca PROCEDURE

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.

Control Group (Suprainguinal Fascia Iliaca Block)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Hospital Galway: lead

Study Sites (1)

Merlin Park Hospital, Galway

Galway, Ireland

RECRUITING

Central Study Contacts

Anna L Horgan, MC BCh BAO FCAI

CONTACT

+353857848200; annahorgan2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor John Laffey MD, DSc

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: March 6, 2026
• Study Start: November 18, 2025
• Primary Completion (Estimated): November 18, 2027
• Study Completion (Estimated): November 18, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

IE (1)