Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000935437
Ethics application status
Approved
Date submitted
10/06/2016
Date registered
13/07/2016
Date last updated
30/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of ultrasound-guided adductor canal block on postoperative quality of recovery after arthroscopy knee surgery
Scientific title
Effects of ultrasound-guided adductor canal block on postoperative quality of recovery after arthroscopy knee surgery
Secondary ID [1] 289106 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Complications 298565 0
meniscus injury 299294 0
Condition category
Condition code
Anaesthesiology 298649 298649 0 0
Pain management
Musculoskeletal 299288 299288 0 0
Other muscular and skeletal disorders
Surgery 299289 299289 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants had an ultrasound-guided adductor canal block (ACB) performed 30 minutes prior to general anaesthesia. ACB was performed by a single consultant anaesthetist using 10ml of 0.5% ropivacaine
Intervention code [1] 294610 0
Treatment: Drugs
Comparator / control treatment
Ultrasound-guided adductor canal block will be adminstered with isotonic saline 0.9% 10ml before induction, and the anesthesia was applied as group ACB.
Control group
Placebo

Outcomes
Primary outcome [1] 298145 0
The quality of recovery is assessed with a 40-item quality-of-recovery questionnaire
(QoR-40)
Timepoint [1] 298145 0
The quality of recovery is assessed on the day before surgery and 24h after surgery
Secondary outcome [1] 323264 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 [1] 323264 0
Postoperative pain is assessed at 30min, 1, 2, 4, 8 and 24h after surgery
Secondary outcome [2] 323265 0
Cumulative opioid consumption is recoreded by review of medical records
Timepoint [2] 323265 0
Calculation of opioid consumption should be considered from initiation of surgery to postoperative 24h
Secondary outcome [3] 323266 0
Patient’s satisfaction is assessed with a 10-point numerical rating scale: 10= excellent, 1= bad
Timepoint [3] 323266 0
Patient’s satisfaction is evaluated on postoperative 24h
Secondary outcome [4] 323267 0
The incidence of postoperative nausea and vomiting is assessed by verbal self-report by participant.
Timepoint [4] 323267 0
Every participant would be asked the incidence of nausea and vomiting during postoperative 24h

Eligibility
Key inclusion criteria
Age 18 to 60years
ASA physical status were I or II
Body mass index were between 18 and 35 kg/m2
Scheduled for arthroscopic knee surgery
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have history of allergic to local anesthetics, opioid drug or alcohol abuse, intake of any analgesic drug within 48 h before surgery, any signs of infection in the vicinity of the place of acupuncture treatment

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 ACB 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
Statistical analysis were assessed with the use of SPSS version 20.0 (SPSS Inc., Chicago, IL, USA). The normality of distribution was estimated by the Kolmogorov–Smirnov test. Parametric data were expressed as the mean[standard deviation (SD)] and were compared in a t test .Nonparametric data were presented as median[interquartile range (IQR)] and assessed by using the Mann–Whitney test. Categorical variables were expressed as the number of patients (%) and mean values were compared in x2 test or Fisher exact test as appropriate. All reported P-values are two-tailed, and at a 5% level of significance.
The sample size evaluation was based the global QoR-40 scores on our pilot study. In a previous study, we accepted a 10-point difference performs a clinically relevant difference in quality of recovery. Based on the result of previous study, sample size per group were assessed that 28 subjects would be sufficient with a = 0.05 and a power of 80%. Taking into account an expected lost or follow-up data rate of 10%, the final sample size was 62 patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/09/2016
Date of last participant enrolment
Anticipated
30/11/2016
Actual
20/09/2017
Date of last data collection
Anticipated
Actual
22/09/2017
Sample size
Target
62
Accrual to date
Final
62
Recruitment outside Australia
Country [1] 7843 0
China
State/province [1] 7843 0
Fujian

Funding & Sponsors
Funding source category [1] 293476 0
Self funded/Unfunded
Name [1] 293476 0
Yusheng Yao
Country [1] 293476 0
China
Primary sponsor type
Individual
Name
Yusheng Yao
Address
No.134 Dongjie Street, Fujian Provincial Hospital.Fuzhou, Fujian, China, 350001
Country
China
Secondary sponsor category [1] 292300 0
Hospital
Name [1] 292300 0
Fujian Provical Hospital
Address [1] 292300 0
No.134 Dongjie Street,Fujian Provincial Hospital. Fuzhou, Fujian, China, 350001
Country [1] 292300 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295224 0
The Biological-Medical Ethical Committee of Fujian Provincial Hospital
Ethics committee address [1] 295224 0
Ethics committee country [1] 295224 0
China
Date submitted for ethics approval [1] 295224 0
23/12/2015
Approval date [1] 295224 0
21/03/2016
Ethics approval number [1] 295224 0
K2016-3-21

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 927 927 0 0
/AnzctrAttachments/370606-Ethics.pdf

Contacts
Principal investigator
Name 65482 0
Prof Yusheng Yao
Address 65482 0
No.134 Dongjie Street,Fujian Provincial Hospital.Fuzhou, Fujian, China, 350001
Country 65482 0
China
Phone 65482 0
+8613559939629
Fax 65482 0
Email 65482 0
[email protected]
Contact person for public queries
Name 65483 0
Yusheng Yao
Address 65483 0
No.134 Dongjie Street,Fujian Provincial Hospital. Fuzhou, Fujian, China, 350001
Country 65483 0
China
Phone 65483 0
+8613559939629
Fax 65483 0
Email 65483 0
[email protected]
Contact person for scientific queries
Name 65484 0
Yusheng Yao
Address 65484 0
No.134 Dongjie Street,Fujian Provincial Hospital. Fuzhou, Fujian, China, 350001
Country 65484 0
China
Phone 65484 0
+8613559939629
Fax 65484 0
Email 65484 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.