Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001628437
Ethics application status
Approved
Date submitted
15/02/2016
Date registered
24/11/2016
Date last updated
30/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does ultrasound-guided bilateral superficial cervical plexus block improve the quality of recovery after thyroidectomy?
Scientific title
Does ultrasound-guided bilateral superficial cervical plexus block improve the quality of recovery after thyroidectomy?
Secondary ID [1] 288391 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Complications 297396 0
Thyroid disease 297397 0
Condition category
Condition code
Anaesthesiology 300631 300631 0 0
Pain management
Metabolic and Endocrine 300882 300882 0 0
Thyroid disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound-guided bilateral superficial cervical plexus block will be administered with ropivacaine 0.5% 10mL immediately following induction of general anaesthesia. All ultrasound-guided bilateral superficial cervical plexus block will be performed by an same consultant anaesthetist.
Intervention code [1] 293698 0
Treatment: Drugs
Comparator / control treatment
Ultrasound-guided bilateral superficial cervical plexus block will be administered with normal saline 0.9% 10mL
Control group
Placebo

Outcomes
Primary outcome [1] 297130 0
The primary outcome was the quality of recovery, which is assessed with the Quality of Recovery 40 questionnaire (QoR-40).
Timepoint [1] 297130 0
The quality of recovery was assessed on the day before surgery and 24 h after surgery
Secondary outcome [1] 320112 0
Postoperative pain intensity was simulated by visual analogue scale (VAS) ranging from 0 to 10, of which 0 indicated no pain, and 10 is the worst pain imaginable.
Timepoint [1] 320112 0
Postoperative pain intensity was rated at postoperative hours 0.5, 1, 2, 4, 8 and 24
Secondary outcome [2] 320113 0
Patient’s satisfaction was evaluated by 10-point numerical rating scale ranging from 0 to 10, which 0 indicated not pleased, and 10 is very satisfied.
Timepoint [2] 320113 0
Patient’s satisfaction was evaluated on postoperative 24 h
Secondary outcome [3] 320114 0
Side effects include tachycardia, hypotension,hyoxemia,nausea and vomiting,in which tachycardia is assessed with electrocardiogram, hypotension is assessed with sphygmomanometry, hyoxemia is assessed with blood oxygen saturation monitor. nausea and vomiting is documented by patients'complaint.
Timepoint [3] 320114 0
Secondary outcomes will be assessed from the administration of the bilateral superficial cervical plexus until 24 hours post surgery.

Eligibility
Key inclusion criteria
Patients will be scheduled for thyroidectomy
ASA physical status were I or II
Age: 18 to 60 years,
body mass index:18 to 35 kg/m2
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
History of allergic to local anesthetics;
Opioid drug or alcohol abuse;
Intake of any analgesic drug within 48 h before surgery

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)
Allocation was concealed by sealed opaque envelopes that were opened by a nurse not involved with the care of the individuals.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a 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
Our sample size calculation for the two-tailed testing of the bilaterl superficial cervial plexus block superiority hypothesis was based on the global QoR-40 scores. A power analysis using a type I error estimate of 5% (alpha = 0.05) and a power (1-beta) of 80% indicated that a sample of 31 subjects per group would be required. To account for the loss of some study participants,74 subjectswere enrolled in this study.
Analyses were performed using SPSS 18.0 software (SPSS Inc., Chicago, IL, USA). Continuous data were expressed as mean [standard deviation (SD)] or median [interquartile range (IQR)] and compared with independent t-test or Mann–Whitney U test, respectively. Categorical variables were reported as the number of patients (%) and evaluated by the Fisher’s exact test or the chi-squre test where appropriate. All reported P-values are two-tailed, and a P-value of less than 0.05 was considered statistical significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2016
Actual
13/01/2017
Date of last participant enrolment
Anticipated
20/04/2017
Actual
23/10/2017
Date of last data collection
Anticipated
24/04/2017
Actual
24/10/2017
Sample size
Target
74
Accrual to date
Final
74
Recruitment outside Australia
Country [1] 7546 0
China
State/province [1] 7546 0
Fujian

Funding & Sponsors
Funding source category [1] 292744 0
Hospital
Name [1] 292744 0
Fujian Provincial Hospital
Country [1] 292744 0
China
Primary sponsor type
Individual
Name
Yanqing Chen
Address
No.134 Dongjie Street, Fuzhou, Fujian, China, 350001
Country
China
Secondary sponsor category [1] 291538 0
None
Name [1] 291538 0
Address [1] 291538 0
Country [1] 291538 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294386 0
Biological-Medical Ethical Committee of Fujian Provincial Hospital
Ethics committee address [1] 294386 0
Ethics committee country [1] 294386 0
China
Date submitted for ethics approval [1] 294386 0
23/09/2014
Approval date [1] 294386 0
14/02/2015
Ethics approval number [1] 294386 0
K2015-02-11

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 746 746 0 0
/AnzctrAttachments/369979-02031917543ImagePDF.pdf

Contacts
Principal investigator
Name 62974 0
Prof Yusheng Yao
Address 62974 0
No.134 Dongjie Street, Fujian Provincial Hospital,Fuzhou, Fujian, China, 350001
Country 62974 0
China
Phone 62974 0
+86 13559939629
Fax 62974 0
Email 62974 0
[email protected]
Contact person for public queries
Name 62975 0
Yanqing Chen
Address 62975 0
No.134 Dongjie Street, Fujian Provincial Hospital,Fuzhou, Fujian, China, 350001
Country 62975 0
China
Phone 62975 0
+8613314935073
Fax 62975 0
Email 62975 0
[email protected]
Contact person for scientific queries
Name 62976 0
Yusheng Yao
Address 62976 0
No.134 Dongjie Street, Fujian Provincial Hospital,Fuzhou, Fujian, China, 350001
Country 62976 0
China
Phone 62976 0
+86 13559939629
Fax 62976 0
Email 62976 0
[email protected]

No information has been provided regarding IPD availability


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.