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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | First 24 hours post-operatively |
| Opioid consumption in morphine equivalents at 2, 4, 6, 12, 48 hours postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna L Horgan, MC BCh BAO FCAI | Contact | +353857848200 | annahorgan2@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merlin Park Hospital, Galway | Recruiting | Galway | Ireland |
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| 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. |
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| 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 | 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. | 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 | 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 | first 48 hours post operatively |