Total Hip Arthroplasty (THA)
Conditions
Keywords
Total Hip Arthroplasty, Psoas Sheath Block, Regional anaesthesia
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
Interventions
PROCEDUREPsoas 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
PROCEDURESuprainguinal 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.
Sponsors
University College Hospital Galway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of recovery 15 score | 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 | First 24 hours postoperatively | The total 24-hour oxycodone (and morphine-equivalent consumption) will be recorded, documenting all administered doses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical rating scale (NRS) for pain at rest and movement at 2, 4, 6, and 24 hours postoperatively. | First 24 hours post-operatively | This is a scale assessing patient reported pain from 0 to 10, with 10 being the most severe pain |
| 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 | 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 |
| 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 | 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 |
| Opioid related side effects | 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 |
Countries
Ireland
Contacts
CONTACTAnna L Horgan, MC BCh BAO FCAI
Outcome results
None listed