Evaluating the Efficacy of the Psoas Sheath Block for Post Operative Analgesia Following Hip Arthroplasty

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College Hospital Galway

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psoas Sheath Block

    Procedure/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 Iliaca

    Procedure/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.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Intervention Group (Psoas Sheath Block)Experimental treatment 1 intervention
Group B: Control Group (Suprainguinal Fascia Iliaca Block)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
the first 48 hours post-operatively
2

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

Secondary outcomes

1

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
2

Opioid consumption in morphine equivalents at 2, 4, 6, 12, 48 hours postoperatively.

Time frame
First 48 hours post-operatively
3

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
4

Distance mobilised on postoperative day 1.

Time frame
1st day postoperatively

Other outcomes

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