Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000068864p
Ethics application status
Submitted, not yet approved
Date submitted
14/11/2020
Date registered
28/01/2021
Date last updated
28/01/2021
Date data sharing statement initially provided
28/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Control Trial comparing the pain relief effect of the pericapsular nerve group (PENG) block to pretend 'sham' blocks in hip replacement surgery
Scientific title
A Randomised Control Trial comparing the clinical efficacy of the pericapsular nerve group (PENG) block to placebo on pain after hip arthroplasty surgery
Secondary ID [1] 302793 0
None
Universal Trial Number (UTN)
U1111-1261-1797
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hip arthroplasty 319746 0
post-operative pain 319747 0
Condition category
Condition code
Anaesthesiology 317682 317682 0 0
Pain management
Musculoskeletal 317981 317981 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For placement of the PENG block, a low frequency (2.5-5MHz) curvilinear ultrasound probe shall be used. The transducer is placed in a longitudinal plane with the lateral edge over the anterior inferior iliac spine of the hip. The median edge of the probe is rotated caudally to obtain an adequate view of the fascial plane under the psoas tendon along the acetabulum. A 21-Gauge 100mm Sonoplex needle (Pajunk, Geisingen, Germany) shall be inserted and an aspiration check performed prior to a 20 mL injection of local anaesthetic solution into the sub-psoas fascial plane. The local anaesthetic is ropivacaine 0.75%, unless the patient weighs less than 50 kilograms in which case the concentration is adjusted for a maximum of 3mg/kg, and volume maintained at 20mLs.
The block shall be administered once prior to surgery. This shall be administered by an anaesthetist who has extensive clinical experience in this particular regional technique.
Intervention code [1] 319068 0
Prevention
Intervention code [2] 319282 0
Treatment: Drugs
Comparator / control treatment
- The two study interventions are identical in terms of equipment, set-up and personnel. In the case of the ‘sham’ block- surgical drapes are erected to obstruct view from blinded staff and patient, the skin is disinfected and an ultrasound view of the PENG placement anatomy is obtained. No invasive needle placement is done, instead a cross with a standard surgical marker is placed over the area where the block would be placed.
Control group
Placebo

Outcomes
Primary outcome [1] 325726 0
Pain, on an 11 point Likert visual analogue scale from 0 to 10. 0 being the absence of pain and 10 being the worst pain imaginable.
Timepoint [1] 325726 0
Baseline pre-operatively.
Post-operatively: in Recovery, day of surgery on the ward, day 1 and day 2 if still admitted.
Secondary outcome [1] 388913 0
Quadriceps weakness, according to the Medical Research Council (MRC) Manual Muscle Testing grading scale
Timepoint [1] 388913 0
Postoperatively at time of first mobilisation
Secondary outcome [2] 388914 0
Time of first mobilisation as documented by physiotherapy staff
Timepoint [2] 388914 0
Post-operatively, This shall be variable, but typically 2 hours after surgery or later the same day of surgery.
Secondary outcome [3] 388915 0
Patient satisfaction, on a basic 3 point Likert scale (satisfied, ambivalent, unsatisfied) with options for "unable to assess" and also ability to add reasoning if unsatisfied.
Timepoint [3] 388915 0
Day 1 post surgery
Secondary outcome [4] 388916 0
- Multidimensional 24 hour QoR-15 (Quality of Recovery) questionnaire, This is designed to assess impact of pain on recovery and quality of recovery.
Timepoint [4] 388916 0
Baseline pre-operatively, and then again on day 1 post surgery
Secondary outcome [5] 388917 0
Opiate consumption; in morphine equivalents in mg and mcg. This is monitored via the medication charts.
Timepoint [5] 388917 0
Various timepoints: (intra-operatively, in recovery and day 0 and day 1 post-operatively on the ward)
Secondary outcome [6] 388918 0
Time to discharge as documented in the hospital records
Timepoint [6] 388918 0
At the time of discharge from hospital (likely 1-2 days post surgery)
Secondary outcome [7] 390991 0
PROMIS Depression (designed to assess symptoms of depression)
Timepoint [7] 390991 0
Post op day 1, at 0900
Secondary outcome [8] 390992 0
PROMIS Pain Interference (PI) (designed to assess how pain interferes with recovery and activities of daily living).
Timepoint [8] 390992 0
Post op day 1, at 0900
Secondary outcome [9] 390993 0
Psychosocial status: PCS (pain catastrophizing scale).- designed to assess symptoms of catastrophising.
Timepoint [9] 390993 0
Post op day 1, at 0900
Secondary outcome [10] 390994 0
BPI (Brief Pain Inventory). Designed to assess pain.
Timepoint [10] 390994 0
Baseline and at day 1 post op at 0900

Eligibility
Key inclusion criteria
- Hip arthroplasty surgery at Flinders Medical Centre or Noarlunga Hospital
- aged 18 years or older
- no contraindication to regional anaesthesia
- able to give first party consent and provide reliable feedback on symptoms such as pain scores
- Scheduled operative finishing time during standard hours. This is due to the availability of allied health staff, in particular physiotherapy who shall mobilise the patient initially.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be:
- Aged under 18 years of age.
- Inability to give first person consent
- Inability to give consent or participate in post-operative assessments due to dementia, cognitive impairment and/or language barrier.
- Allergy to chlorhexidine, or ropivacaine
- Participant refusal of regional anaesthetic technique
- contraindication to regional anaesthesia

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed. Central randomisation via computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The a priori power calculation was carried out using G*Power 3.1 based on best available published data. This showed a mean pain score reduction in participants receiving the PENG hip block of 7 points out of 10, with a standard deviation of 2 points out of 10. However, hip replacements are less painful postoperatively than hip fractures, and hence a pain score reduction of 7 did not seem feasible, as pain scores postoperatively without a block are already lower than this at our institution. There are no published studies (apart from case studies) which look at hip arthroplasty and PENG pain scores for us to base a power calculation on.
We based our power calculation on an internal pilot study which showed a typical pain score postoperatively of 5 out of 10 for hip arthroplasty patients. Only a few anaesthetists perform PENG blocks in hip arthroplasty surgery, and these participants did perform better with a mean pain score of 3. This pain score reduction is much smaller than that quoted by Giron Arango et al. This is likely due to their study being done in hip fracture participants, which are typically much more painful. Hip arthroplasty patients have thus a lower baseline post-surgery pain score natively, and show a smaller numeric reduction.
Total: N=36
Samples sizes have been calculated using PASS 14 Power Analysis and Sample Size Software (2015). NCSS, LLC. Kaysville, Utah, USA (ncss.com/software/pass).
Using a two-tailed independent-samples t-test for the difference between two unpaired means with an alpha-error of 0.05, beta-error of 0.05, and power of 0.80 it was determined that to detect an effect size of a pain score reduction of 3 out of 10 and a standard deviation of 3 points in the study population, we can place 18 participants in each arm to include an attrition rate of 15%, giving a total number of 36 participants for more than 80% power.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2021
Actual
Date of last participant enrolment
Anticipated
30/09/2021
Actual
Date of last data collection
Anticipated
4/10/2021
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18027 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 18028 0
Noarlunga Health Service - Noarlunga Centre
Recruitment postcode(s) [1] 31999 0
5042 - Bedford Park
Recruitment postcode(s) [2] 32000 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 307220 0
Hospital
Name [1] 307220 0
Flinders Medical Centre
Country [1] 307220 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Drive, Bedford Park 5042, South Australia, Australia
Country
Australia
Secondary sponsor category [1] 307822 0
Hospital
Name [1] 307822 0
Noarlunga Health Service
Address [1] 307822 0
20 Alexander Kelly Dr, Noarlunga Centre SA 5168, Australia
Country [1] 307822 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307317 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 307317 0
Flinders Medical Centre, Flinders Drive, Bedford Park 5042, South Australia, Australia
Ethics committee country [1] 307317 0
Australia
Date submitted for ethics approval [1] 307317 0
30/11/2020
Approval date [1] 307317 0
Ethics approval number [1] 307317 0
292.20

Summary
Brief summary
We hypothesise that, in a surgical setting for hip arthroplasty, the PENG (pericapsular nerve group) regional block is more effective in reducing post-operative pain than placebo.
We propose a study to investigate the effect of the PENG block, compared to placebo in a blinded format

The participant, anaesthetist and surgeon will be blinded to the study medication administered. The post-operative pain team, at FMC and Noarlunga known as the Acute Pain Service (APS), will also be blinded. This team routinely follows up all participants who have undergone a hip arthroplasty. They will know that the participant has received a regional technique, but not whether it is with ropivacaine or placebo.

Post-operatively, each participant will be visited on the ward by the Acute Pain Service which is a routine part of their care. In this consultation they will discuss their pain levels, pain medication use, and ability to mobilise since their surgery, all part of the standard questions asked by this service. As part of this study, Dr Lin (study investigator) shall post-operatively conduct a series of questionnaires, including one or more of the anxiety, depression and delirium assessments. In addition to this, we shall collect general information from the medical records, which will be kept confidential.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106806 0
Dr D-Yin Lin
Address 106806 0
c/o Dept of Anaesthesia
Flinders Medical Centre, Flinders Drive, Bedford Park 5042, SA, Australia
Country 106806 0
Australia
Phone 106806 0
+61 882044266
Fax 106806 0
Email 106806 0
d-yin.lin@sa.gov.au
Contact person for public queries
Name 106807 0
Dr D-Yin Lin
Address 106807 0
c/o Dept of Anaesthesia
Flinders Medical Centre, Flinders Drive, Bedford Park 5042, SA, Australia
Country 106807 0
Australia
Phone 106807 0
+61 882044266
Fax 106807 0
Email 106807 0
d-yin.lin@sa.gov.au
Contact person for scientific queries
Name 106808 0
Dr D-Yin Lin
Address 106808 0
c/o Dept of Anaesthesia
Flinders Medical Centre, Flinders Drive, Bedford Park 5042, SA, Australia
Country 106808 0
Australia
Phone 106808 0
+61 882044266
Fax 106808 0
Email 106808 0
d-yin.lin@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No plans to share IPD.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9745Study protocol  d-yin.lin@sa.gov.au
9746Statistical analysis plan  d-yin.lin@sa.gov.au
9747Informed consent form  d-yin.lin@sa.gov.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.