Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000794404
Ethics application status
Approved
Date submitted
15/02/2016
Date registered
17/06/2016
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Date results information initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Is ultrasound-guided serratus plane block effective for acute and chronic pain after modified radical mastectomy?
Scientific title
Ultrasound-guided serratus plane block for acute pain and chronic pain after modified radical mastectomy: a prospective randomized trial
Secondary ID [1] 288468 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 297501 0
Anesthesia 297502 0
Condition category
Condition code
Anaesthesiology 297691 297691 0 0
Pain management
Cancer 298696 298696 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
30 minutes prior to induction of intravenous anesthesia, patients were received an ultrasound-guided serratus plane block., SPB group was performed with 0.5% ropivacaine 20ml by a single consultant anaesthetist. Patient controlled intravenous analgesia (PCIA) was starting at emergence from anaesthesia : sufentanil 3ug/kg+ tropisetron hydrochloride 0.01mg/kg (diluted with normal saline 100ml) were taken as protocol. The loading dosage was 2ml which administered at emergence from anaesthesia. , background infusion was 1ml/h; bolus dose was 1ml with 15 min lock out). The duration of PCIA is the first 48 hours post surgery.
Intervention code [1] 293807 0
Treatment: Drugs
Comparator / control treatment
Ultrasound-guided serratus plane block (SPB )was not performed before induction, and the anesthesia was applied as group SPB, and intravenous PCIA was used postoperatively. PCIA: sufentanil 3ug/kg+ tropisetron hydrochloride 0.01mg/kg (diluted with normal saline 100ml) were taken as protocol. The loading dosage was 2ml, background infusion was 1ml/h; bolus dose was 1ml with 15 min lock out).
Control group
Active

Outcomes
Primary outcome [1] 297233 0
Chronic pain intensity is assessed with visual analogue scale (VAS) which 0 and 100 mm referring to ‘no pain’ and ‘worst pain imaginable’.
Timepoint [1] 297233 0
postoperative 3 and 6 months at resting state and in movement state
Secondary outcome [1] 320420 0
The cellular immune function is assessed with flow cytometry using a blood sample.
Timepoint [1] 320420 0
Before anesthesia induction, postoperative 1 day, 7 days
Secondary outcome [2] 320797 0
Postoperative pain intensity is assessed with visual analogue scale (VAS) which 0 and 100 mm referring to ‘no pain’ and ‘worst pain imaginable’.
Timepoint [2] 320797 0
postoperative 2h, 4h, 8h, 24h and 48h at resting state and in movement state.

Eligibility
Key inclusion criteria
Patients (aged 18 to 60 years) with American Society of Anesthesiologists (ASA) Physical Status class I or II scheduled for first modified radical mastectomy were included in the study.
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. chronic ethanol, long-term use of psychotropic drugs (e.g. sedative drugs and antidepressant;
2. contraindications for Paravertebral block including coagulopathy, infection at the puncture site, trauma or history of spine surgery;
3. unable to cooperate with this research due to cognitive impairment, psychopathy or not willing for the hospital follow-up;
4. administration of other test drugs or joining in other clinical study in 3 months before our study;
5. received radiotherapy or chemotherapy before surgery;
6. other conditions not allocated for this study out of the researchers consideration.

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)
Treatment allocations were concealed with opaque envelopes, which only assistant who dispensing local anesthetic could open.Treatment allocations were assigned to either the SPB group or the control group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
participants were randomized by using a Excel-generate random code
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2016
Actual
4/07/2016
Date of last participant enrolment
Anticipated
31/12/2017
Actual
23/04/2018
Date of last data collection
Anticipated
Actual
23/10/2018
Sample size
Target
198
Accrual to date
Final
198
Recruitment outside Australia
Country [1] 7570 0
China
State/province [1] 7570 0
Fujian

Funding & Sponsors
Funding source category [1] 292814 0
Government body
Name [1] 292814 0
The Foundation of Fujian Medical Innovation topics
Country [1] 292814 0
China
Primary sponsor type
Government body
Name
Fujian Provincal Health and Family Planning Commission
Address
No.61, Guping Road, Fuzhou, Fujian, China.350001
Country
China
Secondary sponsor category [1] 291555 0
None
Name [1] 291555 0
Address [1] 291555 0
Country [1] 291555 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294387 0
Biological-Medical Ethical Committee of Fujian Provincial Hospital
Ethics committee address [1] 294387 0
No.134 Dongjie Street, l.Fuzhou, Fujian, China, 350001
Ethics committee country [1] 294387 0
China
Date submitted for ethics approval [1] 294387 0
13/12/2015
Approval date [1] 294387 0
28/01/2016
Ethics approval number [1] 294387 0
K2016-01-8

Summary
Brief summary
Breast cancer has continued to be the most common cancer afflicting women, every year, thousands of patients undergo surgery in the region of the breast and axilla. These procedures cause significant acute pain and may progress to chronic pain states in 25–60% of cases .A novel ultrasound-guided anaesthetic technique that may achieve complete paraesthesia of the hemithorax.Patients were allocated to either the general anesthesia group (group control) or SPB (serratus plane block) + general anesthesia groups (group SPB) by using randomized central computer-generated sequence software (SAS 18.0). The allocation ratio was 1:1 for the two groups. Group assignment was concealed by opaque sticking envelops and was given to the researchers.We will evaluate the pain in resting state and movement state by visual analog scale (visual analogue score, VAS), and to study the effect of serratus plane block on the acute pain and chronic pain after modified radical mastectomy.We predict this technique can block primarily the thoracic intercostal nerves and to provide complete analgesia of the lateral part of the thorax. We believe that this may be a viable alternative to paravertebral blockade and thoracic epidural analgesia in this patient population,and may theoretically be associated with a more desirable side-effect profile.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 765 765 0 0
/AnzctrAttachments/370051-ethics approval forms.pdf

Contacts
Principal investigator
Name 63262 0
Prof Yusheng Yao
Address 63262 0
No.134 Dongjie Street, Fujian Provincial Hospital,Fuzhou, Fujian, China, 350001
Country 63262 0
China
Phone 63262 0
+8613559939629
Fax 63262 0
Email 63262 0
[email protected]
Contact person for public queries
Name 63263 0
Prof Yusheng Yao
Address 63263 0
No.134 Dongjie Street, Fujian Provincial Hospital,Fuzhou, Fujian, China, 350001
Country 63263 0
China
Phone 63263 0
+8613559939629
Fax 63263 0
Email 63263 0
[email protected]
Contact person for scientific queries
Name 63264 0
Prof Yusheng Yao
Address 63264 0
No.134 Dongjie Street, Fujian Provincial Hospital,Fuzhou, Fujian, China, 350001
Country 63264 0
China
Phone 63264 0
+8613559939629
Fax 63264 0
Email 63264 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?
Individual participant data underlying published results only will be shared.
When will data be available (start and end dates)?
We would like to share our individual participant data beginning 6 months following main results publication and no end date.
Available to whom?
Our individual participant data will be available to case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Our individual participant data will be available only to achieve the aims in the approved proposal.
How or where can data be obtained?
Our individual participant data will be access subject to approvals by Principal investigator.


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
No additional documents have been identified.