Evaluating the Efficacy of the Sub-psoas Fascial Plane Block for Post-operative Analgesia Following Hemiarthroplasty

NCT06419153 | Not Yet Recruiting DMC

• 1 other identifier: C.A. 3190
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to examine the efficacy and safety of an ultrasound-guided regional anaesthetic technique intended to provide pain relief following hip surgery. It involves targeting a layer of tissue known as the psoas fascia, where the nerves of the lumbar plexus, supplying the lower limb, are located. There are many well-established ultrasound-guided techniques that target similar anatomical planes and structures, such as the psoas compartment block and quadratus lumborum plane block, which are widely used in clinical practice. This is not a new technique but rather a new approach to a well-established and utilized technique (the psoas compartment block). Early remobilisation plays a key role in the recovery of post-operative patients, helping to reduce the incidence of pneumonia, deep vein thrombosis, and delirium. By reducing motor weakness while still providing adequate pain relief and minimizing the use of strong painkillers such as morphine, it will help to reduce the risk of falls and length of hospital stay. An initial case series in GUH has previously followed a small cohort of patients who, following informed consent, underwent the subpsoas fascia plane (SPF) block vs. suprainguinal fascia iliaca block as part of their multimodal pain relief following surgery. It was found that in this group there was a reduction in postoperative pain scores, decreased use of strong painkillers, and earlier time to remobilisation.

Conditions

Hemiarthroplasty

Keywords

anaesthesia, regional; SPF block; hemiarthroplasty; subpsoas fascia block

Outcome Measures

Primary Outcomes (3)

• Evaluation of Efficacy of SPF Block - Quality of Recovery

  Quality of Recovery 15 (QoR15) Score a patient-reported outcome measurement measuring QoR after surgery and anesthesia. minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).

  48 hours

• Opioid Consumption

  Intraoperative and Postoperative Opioid Requirements Quantification

  48 hours

• Pain Score

  Pain score - NRS - Numerical Rating Score requires the patient to rate their pain on a defined scale. 0-10 where 0 is no pain and 10 is the worst pain imaginable

  48 hours

Secondary Outcomes (1)

• Time to remobilisation post-operatively

  48hrs

Study Arms (2)

SPF Block Group

In this RCT, all patients enrolled will be undergoing Emergency HemiArthroplasty in the theatre complex in University Hospital Galway. Under ultrasound-guidance the SPF will be performed by the experienced consultant anaesthesiologist, whereby 30ml of 0.75% Ropivicaine will be slowly injected into the subpsoas fascial plane, whilst at all times throughout and following the procedures the patient will be closely haemodynamically monitored. The patient will be followed up in the recovery post-anaesthetic care unit up to four hours following their surgery. They will then be reviewed by the one of the co-investigators at a timeframe of 0-24 hours and 24-48 hours post-operatively to further establish their analgesic efficacy, their pain scores (see supplementary appendix), quality of recovery, time to remobilization and opioids requirements, ensuring the patient is comfortable and aiming to maximize their recovery period.

No SPF Block Group

In this RCT, all patients enrolled will be undergoing Emergency HemiArthroplasty in the theatre complex in University Hospital Galway Participants randomized to 'standard care' will receive the standard care required as determined by the treating team in the form of intravenous analgesia.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients enrolled will be undergoing Emergency HemiArthroplasty in the theatre complex in University Hospital Galway.

You may qualify if:

• Individuals undergoing orthopaedic surgery at the hip joint in University College Hospital, Galway.
• Individuals over 18 years of age.
• Individuals treated with psoas muscle sympathetic nerve blocks as part of multi-modal analgesic management.
• Individuals with the capacity to make an informed decision regarding study participation.
• Patients that provide written and verbal informed consent.
• Patients whom have not received a fascia iliacus block in the emergency department prior to their surgery.

You may not qualify if:

• Individuals unable to provide informed consent.
• Individuals \< 18 years of age.
• Individuals with an intellectual disability (IQ \< 70), cognitive impairment, delirium or with dementia.
• Allergy to the local anaesthesia block components.
• Patients with absolute or relative contraindication to peripheral nerve blocks.
• Coagulopathy (Prothrombin time/International Normalized Ratio of more than 1.50, Activated Partial Thromboplastin Time of more than 60 seconds).
• Cases judged to be inappropriate by the chief investigator.
• Patients whom have received a fascia iliacus block in the emergency department prior to their surgery

Sponsors & Collaborators

• University College Hospital Galway: lead
• Prof John McDonnell: collaborator
• Prof John Laffey: collaborator

Central Study Contacts

Orla Murphy, MB BCh BAO FCAI

CONTACT

+ 353 91 524 222; murphyoa@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Orla Murphy, Specialist Registrar Anaesthesia

Study Record Dates

• First Submitted: May 4, 2024
• First Posted: May 17, 2024
• Study Start: May 13, 2024
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05