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Tests treatment safety and results for Total Hip Arthroplasty (THA)
Official title Evaluating the Efficacy of the Psoas Sheath Block for Post Operative Analgesia Following Hip Arthroplasty
ClinicalTrials.gov ID: NCT07453498
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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...
- 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...
- Severe Respiratory or Cardiovascular Disease: Any severe respiratory or cardiovascular disease (e.g., severe chronic obstructive pulmonary disease...
See the full eligibility 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
- 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...
- Cognitive impairment or conditions (e.g., dementia with MMSE \<24) that would prevent reliable pain reporting or compliance with post-operative assessments
The study team makes the final eligibility decision.
Where it's taking place
- Galway, Ireland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Galway, Ireland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.