PENG vs placebo 'sham' block RCT

A Randomised Control Trial comparing the clinical efficacy of the PENG block to placebo ‘sham’ blocks in elective hip arthroplasty surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20932

Enrollment

Registered

2020-12-25

Start date

2021-06-28

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, or other indication for hip replacement surgery

Interventions

1.) Non invasive skin markings and blunt needle to simulate a 'sham' block (control group) or 2.) study intervention which is ropivicaine 0.5% 20mLs as a PENG block according to the technique describe

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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.

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Secondary

Measure	Time frame
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. 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. Persistent or chronic pain is defined as pain self-reported by the patient at 6 weeks (persistent) and 3 months (chronic). Persistent or chronic opiate use is defined as opiate use self-reported by the patient at 6 weeks (persistent) and 3 months (chronic). The tertiary outcomes will not be included in a primary analysis.	—

Measure

Time frame

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. 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. Persistent or chronic pain is defined as pain self-reported by the patient at 6 weeks (persistent) and 3 months (chronic). Persistent or chronic opiate use is defined as opiate use self-reported by the patient at 6 weeks (persistent) and 3 months (chronic). The tertiary outcomes will not be included in a primary analysis.

—

Contacts

Public ContactD-Yin Lin

AMC (Supervised by AMC Professor Ruurd Jaarsma)

indysama@gmail.com0434001819

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)