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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
130
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
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.
Merlin Park Hospital, Galway
Galway, Ireland
RECRUITINGQuality 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
Time frame: 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
Time frame: First 24 hours postoperatively
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
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.
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
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.
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
Time frame: 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
Time frame: first 48 hours post operatively
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