Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000028101
Ethics application status
Approved
Date submitted
15/11/2018
Date registered
11/01/2019
Date last updated
28/10/2021
Date data sharing statement initially provided
11/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does bilateral superficial cervical plexus block improve the quality of recovery after anterior cervical spine surgery?
Scientific title
Does bilateral cervical plexus block improve the quality of recovery for patients undergoing anterior cervical spine surgery: a randomised placebo-controlled trial
Secondary ID [1] 296618 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical spine surgery 310424 0
Postoperative recovery 310425 0
Condition category
Condition code
Surgery 309141 309141 0 0
Other surgery
Anaesthesiology 309142 309142 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Immediately following induction of anaesthesia and intubation, bilateral ultrasound guided superficial cervical plexus blocks will be placed by an anaesthetist experienced in delivering the block. Patients randomised to the local anaesthetic group will receive 15mL of 0.2% ropivacaine on each side (totalling 30mLs).
Intervention code [1] 312921 0
Treatment: Drugs
Comparator / control treatment
Patients randomised to the placebo group will receive 15mLs of 0.9% saline on each side.
Control group
Placebo

Outcomes
Primary outcome [1] 308126 0
The primary outcome will be the quality of recovery from surgery measured by the Quality of Recovery questionnaire (QoR-40).
Timepoint [1] 308126 0
The QoR-40 score measured at 24 hours post-operation completion time.
Secondary outcome [1] 354001 0
Opioid usage (converted to equivalent units of oral morphine). This will be assess via audit of the patients electronic medical record.
Timepoint [1] 354001 0
Measured in the first 24hours after surgery
Secondary outcome [2] 354002 0
Numeric pain rating scale for neck pain
Timepoint [2] 354002 0
1 hour, 3 hours, 6 hours, and at 24 hours post-operative time
Secondary outcome [3] 354003 0
Incidence of nausea, measured as a dichotomous variable (present or absent) on a questionnaire designed for the study
Timepoint [3] 354003 0
In the first 24hours after surgery
Secondary outcome [4] 354005 0
The length of hospital stay is measured via the electronic medical record.
Timepoint [4] 354005 0
From admission to discharge
Secondary outcome [5] 365305 0
Incidence of vomiting, measured as a dichotomous variable (present or absent) on a questionnaire designed for the study
Timepoint [5] 365305 0
In the first 24 hours

Eligibility
Key inclusion criteria
Patients either:
- undergoing anterior cervical discectomy and fusion
- undergoing anterior cervical disc arthroplasty
- with isolated cervical spine trauma requiring anterior fusion only
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients:
- with multitrauma
- undergoing anterior cervical vertebrectomy and reconstruction
- undergoing posterior fixation in addition to anterior surgery
- undergoing surgery for malignancy
- with allergies to ropivacaine or bupivacaine
- that are pregnant
- that have neurologic or psychiatric condition that would prevent completion of the QoR-40 questionnaire

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)
The pharmacy will produce the solution after receiving the randomisation notice, and will send the blinded solution to theatre on the day of surgery in a vial marked:

“ROPIVACAINE 0.2% OR PLACEBO 15ML",

along with the patient’s name, study enrolment number, and expiry date.
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 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 is the QoR-40 score at 24 hours post-operatively, and thus we are planning a study of a continuous response variable from independent control and experimental subjects with 1 control per group. We used an MCID of 7.5 for the QoR-40, as discussed above. If the true difference between the groups is 7.5, we will need a study of 64 subjects in each group to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The type 1 error associated with this test of the null hypothesis is 0.05.
Allowing for a dropout rate of 5%, we will randomise 136 patients (68 in each group). The software used to do the calculation was PS from the University of Vanderbilt, USA.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2019
Actual
21/10/2019
Date of last participant enrolment
Anticipated
1/10/2022
Actual
Date of last data collection
Anticipated
2/10/2022
Actual
Sample size
Target
136
Accrual to date
17
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12422 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [2] 12808 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 12809 0
Nepean Private Hospital - Kingswood
Recruitment postcode(s) [1] 24695 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 25279 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 301195 0
Self funded/Unfunded
Name [1] 301195 0
Matthew Tait
Country [1] 301195 0
Australia
Funding source category [2] 301525 0
Self funded/Unfunded
Name [2] 301525 0
Dr Thananchayan Elalingam
Country [2] 301525 0
Australia
Funding source category [3] 301526 0
Other Collaborative groups
Name [3] 301526 0
Macquarie Neurosurgery
Country [3] 301526 0
Australia
Funding source category [4] 310048 0
Commercial sector/Industry
Name [4] 310048 0
Australian Pacific Medical
Country [4] 310048 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd, North Ryde NSW 2109
Country
Australia
Secondary sponsor category [1] 300820 0
None
Name [1] 300820 0
Address [1] 300820 0
Country [1] 300820 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301936 0
NHRMC HREA Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 301936 0
Ethics committee country [1] 301936 0
Australia
Date submitted for ethics approval [1] 301936 0
31/12/2018
Approval date [1] 301936 0
28/03/2019
Ethics approval number [1] 301936 0
5201949827706
Ethics committee name [2] 309743 0
Nepean Blue Mountains Local Health District Human Research Ethics Committee
Ethics committee address [2] 309743 0
Ethics committee country [2] 309743 0
Australia
Date submitted for ethics approval [2] 309743 0
Approval date [2] 309743 0
Ethics approval number [2] 309743 0
Reference 2019/ETH10684

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

Contacts
Principal investigator
Name 88618 0
Dr Thananchayan Elalingam
Address 88618 0
Macquarie University Hospital
3 Technology Pl
Macquarie University
NSW 2109
Country 88618 0
Australia
Phone 88618 0
+61 2 98123000
Fax 88618 0
Email 88618 0
[email protected]
Contact person for public queries
Name 88619 0
Thananchayan Elalingam
Address 88619 0
Macquarie University Hospital
3 Technology Pl
Macquarie University
NSW 2109
Country 88619 0
Australia
Phone 88619 0
+61 2 98123000
Fax 88619 0
Email 88619 0
[email protected]
Contact person for scientific queries
Name 88620 0
Michael Mulcahy
Address 88620 0
Macquarie Neurosurgery
201/2 Technology Pl
Macquarie Park
NSW 2109
Country 88620 0
Australia
Phone 88620 0
+61 2 98123900
Fax 88620 0
Email 88620 0
[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?
Deidentified patient data
When will data be available (start and end dates)?
For 10 years from the publication of the trial results
Available to whom?
To any professional upon reasonable request
Available for what types of analyses?
Any reasonable purpose
How or where can data be obtained?
From the corresponding author upon written request. Chief investigators email will be made available on the published trial results.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
914Study protocol    376390-(Uploaded-23-06-2021-13-39-59)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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