MedPath

PENG vs placebo 'sham' block RCT

Conditions
Osteoarthritis, or other indication for hip replacement surgery
Registration Number
NL-OMON20932
Lead Sponsor
ONE
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
36
Inclusion Criteria

All primary elective hip arthroplasty surgery patients at Flinders Medical Centre and Noarlunga Hospital

Exclusion Criteria

Cognitive impairment, aged under 18, patient refusal, operation scheduled to finish after hours (due to availability of allied health- especially physiotherapy to mobilise), revision surgery

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pain score on day 0 (3 hours post-operatively). As a visual numeric rating scale from 0 to 10, zero being no pain and 10 being the worst pain imaginable.<br><br>This shall be collected as a baseline pre-operatively (maximum on movement), and then post-operatively in the Recovery (PACU) Unit, and the morning of Day 1 on the ward, All pain scores are maximum for the time frame. These shall be on active movement, as they shall first mobilise with Physiotherapy prior to the collection of pain scores.
Secondary Outcome Measures
NameTimeMethod
Pain scores on Day 1 post-operatively, and Day 2 if they are still admitted. Time to discharge, patient reported outcome measures, complications, opiate consumption, quadriceps strength measured using Oxford grading scale, patient satisfaction, TUG test (timed up and go), PROMs. Possibly time to first mobilisation.<br><br><br>There is also a possible secondary analysis of tertiary outcomes to follow at a later date- of chronic pain and opiate use at 3 months post-operatively. This data shall be collected via a phone call or at the orthopaedic follow up appointments at 6 weeks and 3 months.<br>Persistent or chronic pain is defined as pain self-reported by the patient at 6 weeks (persistent) and 3 months (chronic).<br>Persistent or chronic opiate use is defined as opiate use self-reported by the patient at 6 weeks (persistent) and 3 months (chronic). <br>The tertiary outcomes will not be included in a primary analysis.
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