Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000844549
Ethics application status
Approved
Date submitted
19/07/2015
Date registered
14/08/2015
Date last updated
18/12/2018
Date data sharing statement initially provided
18/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does infiltration of local anaesthesia improve recovery after anterior hip replacement?
Scientific title
A prospective randomised double-blind placebo-controlled parallel-group two-arm superiority trial to determine the efficacy of local infiltration analgesia for anterior total hip replacement.
Secondary ID [1] 287114 0
Nil known
Universal Trial Number (UTN)
U1111-1172-3430
Trial acronym
LIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
total hip replacement 295641 0
local infiltration analgesia 295642 0
postoperative recovery 295643 0
Condition category
Condition code
Anaesthesiology 295922 295922 0 0
Pain management
Musculoskeletal 295923 295923 0 0
Osteoarthritis
Musculoskeletal 295924 295924 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be a prospective, randomised, double-blind, placebo-controlled, parallel-group, two-arm superiority trial. Eligible participants will be aged 50-80 years undergoing primary unilateral anterior THR for osteoarthritis. Participants will be assigned to intraoperative periarticular infiltration of 2.5ml/kg of 0.2% ropivacaine or 0.9% saline. All other care, including anaesthetic technique, postoperative analgesia and mobilisation programs, will be the same for both groups.
Intervention code [1] 292360 0
Treatment: Drugs
Comparator / control treatment
0.9% saline placebo
Control group
Placebo

Outcomes
Primary outcome [1] 295599 0
Quality of Recovery-15 score. QoR-15 is a well-validated patient reported outcome measure, designed to assess generic early postoperative quality of recovery. It consists of 15 questions on an 11 point scale to give a potential total score of 150. The questions are whether the participant has ‘been able to breathe easily’, ‘been able to enjoy food’, ‘feeling rested’, ‘have had a good sleep’, ‘able to look after personal toilet and hygiene unaided’, ‘able to communicate with family or friends’, ‘getting support from hospital doctors and nurses’, ‘able to return to work or usual home activities’, ‘feeling comfortable and in control’, ‘having a feeling of general well-being’, ‘moderate pain’, ‘severe pain’, ‘nausea or vomiting’, ‘feeling worried or anxious’ and ‘feeling sad or depressed’.
Timepoint [1] 295599 0
Postoperative day 1
Secondary outcome [1] 315944 0
Numerical Rating Score for pain - worst NRS at rest and on movement in the past 24 hours
Timepoint [1] 315944 0
Postoperative day 1 and 2
Secondary outcome [2] 315945 0
Oral morphine equivalent consumption - total dose of oral oxycodone and converted dose of intravenous fentanyl recorded on the patient drug chart in the past 24 hours
Timepoint [2] 315945 0
Postoperative day 1 and 2
Secondary outcome [3] 315946 0
10-metre Walk Test (10MWT) - time taken for the patient to walk 10 metres, as measured by the treating physiotherapist
Timepoint [3] 315946 0
Postoperative day 1
Secondary outcome [4] 315947 0
Length of hospital stay - defined by readiness for discharge, in days, from hospital records.
Timepoint [4] 315947 0
Day of discharge from hospital acute ward
Secondary outcome [5] 320230 0
Brief Pain Inventory. The Brief Pain Inventory (BPI) is a self-report measure which assesses pain and its interference with physical and emotional functioning and has established reliability and validity. Its use is supported by the IMMPACT recommendations for assessing pain in clinical trials
Timepoint [5] 320230 0
Postoperative day 90

Eligibility
Key inclusion criteria
Patients aged 50 - 80 years undergoing primary unilateral anterior THR for osteoarthritis, who are able to provide informed consent.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will not be eligible if they take regular opioids other than codeine, have an allergy or contraindication to the proposed analgesic or anaesthetic technique, ASA > 3, BMI > 40, are pregnant, have undergone lower limb joint replacement in the preceding 6 months or are scheduled for any further surgery within 30 days.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Before study commencement, 114 opaque, sealed, stapled envelopes containing the written letter ‘R’ for 0.2% ropivacaine or ‘S’ for 0.9% saline will be placed in sequential order, according to the stratified randomisation schedule. They will be labelled, placed in a secure box and stored in Compounding Pharmacy at Epworth Richmond. This will be done by two competent individuals who are not otherwise involved in this study. The sterile study solutions will be pre-prepared in individual identical containers with content labels by an independent hospital pharmacist. After enrolling a participant on the day of surgery, the research nurse will inform the pharmacist of the name, gender and study number of the participant. The pharmacist will write the participant’s name on the relevant envelope, then open it to determine the study drug to be supplied. The allocated drug container will be relabelled with the participant’s name, gender, study number and the words ‘0.2% ropivacaine or 0.9% saline’, then transported to the operating suite. Allocation will be concealed until after completion of statistical analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A biostatistician will prepare a computer-generated randomisation schedule using random permuted blocks. Participants will be allocated to one of of two treatment arms. Based on best practice for smaller samples and female: male ratio (1.5:1) from previous data, randomisation will be stratified by gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary endpoint of the study is group difference in quality of recovery as measured by the QoR-15. Examination of the relevant literature as well as discussion with the developer of the QoR-15, suggests that a difference in group means between the placebo and the LIA group of 10 points on the QoR-15 could be expected, and is clinically significant. The pooled standard deviation of the QoR-15 score for the two groups is estimated to be 12-15. Using the conservative estimate of 15 for the SD, the expected effect size is estimated to be 10/15 = 0.67. Assuming a statistical power of 0.90 and a 2-tailed alpha value of 0.05, and employing SAS Power and Sample Size, 49 patients per group would be required. Allowing for 15% attrition, 57 patients per group will be required, for a total of 114 patients.

However, a recent study by the developers of the QoR-15 determined the Minimal Clinical Important Difference (MCID), to be 8 points, lower than the 10 points used in the original sample size calculation. MCID is the smallest change in score that constitutes a clinically meaningful change in quality of recovery. Therefore this value of 8 is the value which should be used to calculate the trial’s sample size. Employing the reported MCID of 8 points difference, and an expected pooled standard deviation of 15 leads to an expected effect size of 8/15 = 0.53, lower than the original effect size, but approximating the conventionally defined Cohen 'medium' effect size of 0.50. Assuming a 2-tailed alpha value of 0.05, 75 participants per group would be required for a statistical power of 0.90.

There is 100% data collection for the primary outcome at postoperative day 1 (100 participants to date). The previous expected 15% rate of attrition is excessive. Allowing for future loss of data for 4 participants, a total of 154 participants will be required. With the inclusion of 6 participants who have been withdrawn and will be replaced, the total number of participants required will be 160.

An intention-to-treat analysis will be used. Group baseline characteristics will be examined for confounding factors. The primary outcome, QoR-15 score, will be analysed with means and standard deviations, as will other dimensional variables, with methods appropriate for extreme scores that have previously been applied to the analysis of musculoskeletal data being employed if necessary. Categorical variables will be analysed using appropriate binomial or chi-square tests, while count variables will be analysed using appropriate methods such as those based upon the Poisson distribution. 95% confidence intervals will be computed throughout. Statistical analyses will be conducted using standard packages such as Stata v13. No interim analysis is planned.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2016
Actual
20/04/2016
Date of last participant enrolment
Anticipated
30/06/2018
Actual
28/08/2018
Date of last data collection
Anticipated
30/09/2018
Actual
28/11/2018
Sample size
Target
160
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4062 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 9988 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 291670 0
Hospital
Name [1] 291670 0
Epworth Research Institute
Country [1] 291670 0
Australia
Funding source category [2] 298463 0
Charities/Societies/Foundations
Name [2] 298463 0
Anaesthesia and Pain Medicine Foundation, Australian and New Zealand College of Anaesthetists
Country [2] 298463 0
Australia
Primary sponsor type
Individual
Name
Dr Nicole Tan
Address
Anaesthetic Services,
Suite 4, Level 3, The Epworth Centre
32 Erin St
Richmond
Victoria 3121
Country
Australia
Secondary sponsor category [1] 290346 0
Hospital
Name [1] 290346 0
Epworth Clinical Trials and Research Centre
Address [1] 290346 0
185–187 Hoddle Street
Richmond
VIC 3121
Country [1] 290346 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293200 0
Epworth HREC
Ethics committee address [1] 293200 0
Ethics committee country [1] 293200 0
Australia
Date submitted for ethics approval [1] 293200 0
Approval date [1] 293200 0
16/06/2015
Ethics approval number [1] 293200 0
680-15

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58882 0
Dr Nicole Tan
Address 58882 0
Anaesthetic Services
Suite 4, Level 3, The Epworth Centre
32 Erin St
Richmond
Vic 3121
Country 58882 0
Australia
Phone 58882 0
+61 3 94277899
Fax 58882 0
Email 58882 0
[email protected]
Contact person for public queries
Name 58883 0
Donna McCallum
Address 58883 0
Epworth Clinical Trials and Research Centre
185-187 Hoddle St
Richmond
Vic 3121
Country 58883 0
Australia
Phone 58883 0
+61 3 99368068
Fax 58883 0
Email 58883 0
[email protected]
Contact person for scientific queries
Name 58884 0
Nicole Tan
Address 58884 0
Anaesthetic Services
Suite 4, Level 3, The Epworth Centre
32 Erin St
Richmond
Vic 3121
Country 58884 0
Australia
Phone 58884 0
+61 3 94277899
Fax 58884 0
Email 58884 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImpact of Local Infiltration Analgesia on the Quality of Recovery After Anterior Total Hip Arthroplasty: A Randomized, Triple-Blind, Placebo-Controlled Trial.2019https://dx.doi.org/10.1213/ANE.0000000000004255
N.B. These documents automatically identified may not have been verified by the study sponsor.