Total Hip Arthroplasty (THA)NCT07453498
Evaluating the Efficacy of the Psoas Sheath Block for Post Operative Analgesia Following Hip Arthroplasty
A study testing Psoas Sheath Block and Suprainguinal Fascia Iliaca in people with Total Hip Arthroplasty (THA), run by University College Hospital Galway at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty (THA)
- What is being tested?
- Psoas Sheath Block and Suprainguinal Fascia Iliaca
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteIreland
- Study dates
- 18 Nov 2025to 18 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Merlin Park Hospital, Galway
Galway
Anna L Horgan, MB BCh BAO FCAI, +353857848200, annahorgan2@gmail.com
About this study
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)
- Being tested
- Psoas Sheath Block, Suprainguinal Fascia Iliaca
- Keywords
- Total Hip Arthroplasty, Psoas Sheath Block, Regional anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psoas Sheath BlockProcedure or surgery
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 IliacaProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Suprainguinal Fascia Iliaca |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
This is a scale assessing patient reported pain from 0 to 10, with 10 being the most severe pain
Measured: First 24 hours post-operatively
Opioid consumption in morphine equivalents at 2, 4, 6, 12, 48 hours postoperatively.
Measured: 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
Measured: first day post operatively
Distance mobilised on postoperative day 1.
Measured: 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
Measured: 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
Measured: first 48 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start18 Nov 2025
- Primary completion18 Nov 2027 (estimated)
- Study completion18 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Arthroplasty (THA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Hospital Galway
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Laffey, University College Hospital Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453498
- Sponsor's protocol ID
- C.A.3190
- Status last verified
- Mar 2026
- First submitted
- 25 Nov 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of the Psoas Sheath Block for Post Operative Analgesia Following Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT07453498
- Acronym / sponsor ID
- C.A.3190
- Conditions
- Total Hip Arthroplasty (THA)
- Keywords
- Total Hip Arthroplasty, Psoas Sheath Block, Regional anaesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 18 Nov 2027 (estimated)
- Study completion
- 18 Nov 2027 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Psoas Sheath Block) | Experimental | Procedure: Psoas Sheath BlockIntervention 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. |
| Control Group (Suprainguinal Fascia Iliaca Block) | Active comparator | Procedure: Suprainguinal Fascia IliacaControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psoas Sheath BlockIntervention 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 | Procedure or surgery | Intervention Group (Psoas Sheath Block) |
| Suprainguinal Fascia IliacaFascia 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 or surgery | Control Group (Suprainguinal Fascia Iliaca Block) |
Primary outcome
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
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psoas Sheath Block and Suprainguinal Fascia Iliaca in people with Total Hip Arthroplasty (THA), run by University College Hospital Galway at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna L Horgan, MC BCh BAO FCAI (+353857848200, annahorgan2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery 15 score (time frame: the first 48 hours post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.