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NCT Number: NCT07453498

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

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Key information

Conditions

Total Hip Arthroplasty (THA)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Merlin Park Hospital, Galway

Galway, Ireland

Location status: Recruiting

Location contact

Anna L Horgan, MB BCh BAO FCAI

CONTACT

[email protected]

+353857848200

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Quality of recovery 15 score

    Time frame: 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

  2. Total oral morphine equivalents at 24 hours

    Time frame: First 24 hours postoperatively

    The total 24-hour oxycodone (and morphine-equivalent consumption) will be recorded, documenting all administered doses

Secondary outcomes

  1. 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

    This is a scale assessing patient reported pain from 0 to 10, with 10 being the most severe pain

  2. Opioid consumption in morphine equivalents at 2, 4, 6, 12, 48 hours postoperatively.

    Time frame: First 48 hours post-operatively

  3. Cumulated ambulatory score (CAS) on postoperative day 1.

    Time frame: first day post operatively

    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

  4. Distance mobilised on postoperative day 1.

    Time frame: 1st day postoperatively

  5. Patient satisfaction with pain management, assessed using a Likert scale on postoperative day 1.

    Time frame: Post operative 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

  6. Opioid related side effects

    Time frame: first 48 hours post operatively

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Anna L Horgan, MC BCh BAO FCAI

CONTACT

[email protected]

+353857848200

Sponsors and collaborators

Lead sponsor

University College Hospital Galway

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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