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Trial registered on ANZCTR


Registration number
ACTRN12619000071123
Ethics application status
Approved
Date submitted
14/01/2019
Date registered
18/01/2019
Date last updated
28/01/2020
Date data sharing statement initially provided
18/01/2019
Date results information initially provided
28/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
New nerve block to improve pain relief after hip replacement
Scientific title
Erector spinae block for total hip arthroplasty - a randomised trial to assess analgesic efficacy
Secondary ID [1] 297103 0
Nil
Universal Trial Number (UTN)
U1111-1226-7064
Trial acronym
B-Hip Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesia
311074 0
Hip Replacement 311075 0
Pain 311076 0
Condition category
Condition code
Surgery 309713 309713 0 0
Other surgery
Anaesthesiology 309769 309769 0 0
Pain management
Musculoskeletal 309770 309770 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ropivacaine 0.2% 30mls
Delivered by anaesthetist via nerve block injection needle under ultrasound guidance to the transverse process of the 2nd lumbar vertebra - erector spine block
Intervention code [1] 313347 0
Treatment: Drugs
Comparator / control treatment
Placebo = 30mls of Saline 0.9%
Delivered by anaesthetist via nerve block injection needle under ultrasound guidance to the transverse process of the 2nd lumbar vertebra - erector spine block
Control group
Placebo

Outcomes
Primary outcome [1] 318675 0
Pain score on numeric rating scale 0-10 with movement of the operated leg
Timepoint [1] 318675 0
6 hours postoperative
Secondary outcome [1] 365659 0
Pain score numeric rating scale 0-10 with at rest and movement of the operative leg
Timepoint [1] 365659 0
24 hours postoperative
Secondary outcome [2] 365660 0
Quality of recovery score (QoR-15)
Timepoint [2] 365660 0
24 hours postoperative
Secondary outcome [3] 365661 0
Length of stay from hospital records
Timepoint [3] 365661 0
Number of days until discharge from hospital or to rehabilitation unit
Secondary outcome [4] 365663 0
Mobilisation - composite outcome of ability to achieve standardised physiotherapy thresholds during routine daily Physiotherapy sessions. This will be recorded by physiotherapists in the perioperative medical record.
a. Ability to stand on the day of surgery
b. Ability to walk 5m on Day1 AM
c. Ability to walk 20m on Day 1 PM
d. Ability to walk 40m on Day2
Timepoint [4] 365663 0
Day 1 and Day 2 post-operative

Eligibility
Key inclusion criteria
1. Adults, aged > 18 years old, not pregnant
2. Elective unilateral total hip arthroplasty
3. Mentally competent to provide informed own written consent in English
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Eligible patients who are unable or unwilling to consent
2. Failure of spinal anaesthetic technique
3. Change in planned surgical technique due to for example femoral fracture requiring additional surgical procedures
4. Significant preoperative neuromuscular condition limiting mobility
5. Chronic opioid use > 40mg/d oral morphine equivalent
6. Revision surgery, bilateral surgery
7. Allergy or sensitivity to local anaesthetics

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Pain scores will be presented as a numeric rating scale and the median and interquartile range reported. The study will be powered to detect a 2 point difference in pain scores at 6 hours. Based on data retrieved from pretrial audits this will require 29 in each group. Allowing for attrition we will target 32 per group for a total of 64 patients. Quality of recovery scores will be presented as mean, standard deviation on a scale from 0-150. Mann Whitney-U test will compare the median pain scores between the groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 12883 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 25360 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 301639 0
Self funded/Unfunded
Name [1] 301639 0
Address [1] 301639 0
Country [1] 301639 0
Primary sponsor type
Individual
Name
Dr Mark Lennon
Address
Dept Anaesthesia, Level 1, G Block
Sir Charles Gairdner Hospital
Nedlands, WA 6009
Country
Australia
Secondary sponsor category [1] 301348 0
None
Name [1] 301348 0
Address [1] 301348 0
Country [1] 301348 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302362 0
Hollywood Private Hospital research ethics committee
Ethics committee address [1] 302362 0
Hollywood Private Hospital
Monash Avenue
Nedlands, WA 6009
Ethics committee country [1] 302362 0
Australia
Date submitted for ethics approval [1] 302362 0
12/09/2018
Approval date [1] 302362 0
24/01/2019
Ethics approval number [1] 302362 0
HPH 543

Summary
Brief summary
A recent audit of quality of recovery following hip replacement at Hollywood Hospital indicated that a proportion of patients experience significant pain in the 1st 24h following surgery. The aim of this study is to evaluate the efficacy a new nerve block termed the erector spinae block in reducing pain in the first 24h following hip replacement . A pilot audit of this nerve block technique in 33 patients at Hollywood found it to be safe and effective in reducing pain without any compromise to patient mobility.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89962 0
Dr Mark Lennon
Address 89962 0
Department of Anaesthesia
Sir Charles Gairdner Hospital
Level 1, G Block
Nedlands, WA 6009
Country 89962 0
Australia
Phone 89962 0
+61 8 64573333
Fax 89962 0
Email 89962 0
mjlennon007@gmail.com
Contact person for public queries
Name 89963 0
Dr Mark Lennon
Address 89963 0
Department of Anaesthesia
Sir Charles Gairdner Hospital
Level 1, G Block
Nedlands, WA 6009
Country 89963 0
Australia
Phone 89963 0
+61892861285
Fax 89963 0
Email 89963 0
mjlennon007@gmail.com
Contact person for scientific queries
Name 89964 0
Dr Mark Lennon
Address 89964 0
Department of Anaesthesia
Sir Charles Gairdner Hospital
Level 1, G Block
Nedlands, WA 6009
Country 89964 0
Australia
Phone 89964 0
+61 8 64573333
Fax 89964 0
Email 89964 0
mjlennon007@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Clinical researchers and on a case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Clinical research
How or where can data be obtained?
Access subject to approvals by Principal Investigator
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 1060 0
Study protocol
Citation [1] 1060 0
Link [1] 1060 0
Email [1] 1060 0
Other [1] 1060 0
Type [2] 1061 0
Informed consent form
Citation [2] 1061 0
Link [2] 1061 0
Email [2] 1061 0
Other [2] 1061 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary