ANZCTR - Registration

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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

26/10/2021

Date data sharing statement initially provided

18/01/2019

Date results provided

26/10/2021

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]

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

Hip Replacement

Pain

Condition category

Condition code

Surgery

Other surgery

Anaesthesiology

Pain management

Musculoskeletal

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]

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]

Pain score on numeric rating scale 0-10 with movement of the operated leg

Timepoint [1]

6 hours postoperative

Secondary outcome [1]

Pain score numeric rating scale 0-10 with at rest and movement of the operative leg

Timepoint [1]

24 hours postoperative

Secondary outcome [2]

Quality of recovery score (QoR-15)

Timepoint [2]

24 hours postoperative

Secondary outcome [3]

Length of stay from hospital records

Timepoint [3]

Number of days until discharge from hospital or to rehabilitation unit

Secondary outcome [4]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

12/02/2019

Actual

11/02/2019

Date of last participant enrolment

Anticipated

30/11/2019

Actual

5/11/2019

Date of last data collection

Anticipated

2/12/2019

Actual

10/11/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Hollywood Private Hospital - Nedlands

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hollywood Private Hospital research ethics committee

Ethics committee address [1]

Hollywood Private Hospital
Monash Avenue
Nedlands, WA 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/09/2018

Approval date [1]

24/01/2019

Ethics approval number [1]

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

Dr Mark Lennon

Address

Department of Anaesthesia
Sir Charles Gairdner Hospital
Level 1, G Block
Nedlands, WA 6009

Country

Australia

Phone

+61 8 64573333

Fax

[email protected]

Contact person for public queries

Name

Mark Lennon

Address

Department of Anaesthesia
Sir Charles Gairdner Hospital
Level 1, G Block
Nedlands, WA 6009

Country

Australia

Phone

+61892861285

Fax

[email protected]

Contact person for scientific queries

Name

Mark Lennon

Address

Department of Anaesthesia
Sir Charles Gairdner Hospital
Level 1, G Block
Nedlands, WA 6009

Country

Australia

Phone

+61 8 64573333

Fax

[email protected]

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1060	Study protocol					376726-(Uploaded-14-01-2019-22-41-02)-Study-related document.pdf
1061	Informed consent form					376726-(Uploaded-14-01-2019-22-41-38)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Erector spinae plane block combined with local infiltration analgesia for total hip arthroplasty: A randomized, placebo controlled, clinical trial.	2021	https://dx.doi.org/10.1016/j.jclinane.2020.110153

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically