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Trial registered on ANZCTR
Registration number
ACTRN12621000979853
Ethics application status
Approved
Date submitted
30/06/2020
Date registered
26/07/2021
Date last updated
26/07/2021
Date data sharing statement initially provided
26/07/2021
Date results information initially provided
26/07/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
Comparison of postoperative analgesia for open liver resections
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Scientific title
Effect of patient-controlled epidural compared to intravenous analgesia in addition to single-shot anterior abdominal wall nerve blocks on morphine consumption and pain in patients undergoing open liver resections
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Secondary ID [1]
301657
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
open liver surgery
318086
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postoperative pain
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Condition category
Condition code
Anaesthesiology
316114
316114
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0
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Pain management
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Oral and Gastrointestinal
318868
318868
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
From January 2015 to December 2019, patients who received open liver surgery would receive three different types of analgesic modalities to control postoperative pain, namely intravenous patient controlled analgesia (IV-PCA) only, IV-PCA + nerve blocks and patient controlled epidural analgesia (PCEA) for 3 days. Over the three day period, PCA infusion and bolus dose would be adjusted according to patients' pain level and side effects daily and as requested by patient. The total opioid requirement wouuld be recorded at the end of day 3.
Opioid-related side effects, removal of nasogastric tube and urinary catheter, initiation of bowel movement and the length of hospital stay would also be recorded before patient discharge.
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Intervention code [1]
321261
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Not applicable
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Comparator / control treatment
Control group received IV-PCA only for pain control postoperatively
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Control group
Dose comparison
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Outcomes
Primary outcome [1]
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total morphine consumption at the end of day 3 postoperatively would be obtained from PCA unit
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Assessment method [1]
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Timepoint [1]
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within the first three postoperative days
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Primary outcome [2]
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Subjective pain score at rest and on movement, according to the patient. 5 being the worst pain and 1 being minimal pain.
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Assessment method [2]
324302
0
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Timepoint [2]
324302
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Daily during the first three postoperative days
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Secondary outcome [1]
384279
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A review of patients' medical records were reviewed, in particularly, on what postoperative day were nasogastric tube and urinary catheter removed from the patients.
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Assessment method [1]
384279
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Timepoint [1]
384279
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during hospital admission
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Secondary outcome [2]
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A review of patients' medical records were reviewed, in particularly, on what postoperative day the patients started on fluid and soft diet.
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Assessment method [2]
384280
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Timepoint [2]
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During hospital admission
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Eligibility
Key inclusion criteria
We acquired data from CGMH Pain Service database that included patient demographics, diagnosis of disease, surgical procedures, medication and postoperative adverse effects. From January 2015 to December 2019
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Laparoscopic liver surgeries
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
The statistical information including patient general data, clinical indicators, and perioperative index were collected accurately. Data were analyzed statistically using SPSS Version 25 and R software. The data were presented by mean±standard error of mean (Mean ± SEM), and categorical variables as percentages. Continuous data was compared using the Analysis of variance (ANOVA) and Tukey HSD for further post-hoc analysis. Data were further adjusted for major resection, HCV infection, albumin and hemoglobin using PROC GLM procedure. Proportions were compared using Chi-square test. For all statistical tests, P value < 0.05 was considered to be statistically significant.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
2/04/2020
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Date of last participant enrolment
Anticipated
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Actual
2/04/2020
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Date of last data collection
Anticipated
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Actual
2/04/2020
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Sample size
Target
266
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Accrual to date
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Final
243
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Recruitment outside Australia
Country [1]
22706
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Taiwan, Province Of China
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State/province [1]
22706
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Taoyuan
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Hsin-I Tsai
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Address [1]
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Chang Gung Memorial Hospital
No. 5 Fuxing Street, Gueishan county
Taoyuan, Taiwan, 333
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Country [1]
306091
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Taiwan, Province Of China
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Primary sponsor type
Hospital
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Name
Chang Gung Memorial Hospital, Linkou
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Address
No. 5 Fuxing Street, Gueishan county
Taoyuan, Taiwan, 333
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Country
Taiwan, Province Of China
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Secondary sponsor category [1]
306570
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Individual
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Name [1]
306570
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Hsin I Tsai
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Address [1]
306570
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Chang Gung Memorial Hospital
No. 5 Fuxing Street, Gueishan county
Taoyuan, Taiwan, 333
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Country [1]
306570
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Taiwan, Province Of China
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306311
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Chang Gung Memorial Hospital IRB
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Ethics committee address [1]
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Chang Gung Memorial Hospital
No. 5 Fuxing Street, Gueishan county
Taoyuan, Taiwan, 333
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Ethics committee country [1]
306311
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Taiwan, Province Of China
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Date submitted for ethics approval [1]
306311
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23/03/2020
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Approval date [1]
306311
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02/04/2020
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Ethics approval number [1]
306311
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202000571B0
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Summary
Brief summary
In patients receiving hepato-biliary surgeries, postoperative pain control is of utmost importance in the process of recovery. The golden standard for post-operative pain relief for the open liver surgery is still debated due to inadequate available data, but optimal postoperative pain management is necessary for early mobilization and enhanced respiratory function. Several analgesia managements widely have been used and discussed, including intravenous patient-controlled analgesia (IV-PCA), anterior abdominal wall nerve blocks (NBs) and thoracic epidural analgesia (TEA). TEA is thought to be excellent in pain control, as it provides opioid free postoperative analgesia with fewer respiratory complications; however, it is long criticized for its potentially severe complications such as hypotension, epidural hematoma and infection, coagulopathy, a significant failure rate (20-30%) and possible post-operative organ dysfunction. When TEA is contraindicated or inappropriate, IV-PCA represents an alternative with equivalent post-operative pain control. However, IV-PCA is often associated with adverse drug events (ADEs) related to opioid including nausea, vomiting, urinary retention, delayed return of bowel function, over-sedation, respiratory depression and exacerbation of hepatic encephalopathy. Recently, regional NBs of the anterior abdominal wall, for example, subcostal transversus abdominis plane (TAP) and rectus sheath (RS) blocks, appear to play a role in the multimodal analgesia regimens. These blocks can further provide postoperative analgesia, decrease opioid requirement, reduce the incidence of ADEs and allow patients to breathe and cough more comfortably, altogether may shorten the length of hospital stay and improve the satisfaction of the patients.We hypothesized that IV-PCA + NBs may be non-inferior alternative to patient controlled epidural analgesia (PCEA) in postoperative recovery. We compared three groups of patients using IV-PCA only, IV-PCA + IV-PCA+ NBs and PCEA. Outcomes included total morphine consumption and numerical rating scale (NRS) at rest and on movement over the first three postoperative days, time to remove nasogastric tube, urinary catheter, time to commence on fluid and soft diet and length of hospital stay.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Hsin-I Tsai
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Address
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Chang Gung Memorial Hospital
No. 5 Fuxing Street, Gueishan county
Taoyuan, Taiwan, 333
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Country
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Taiwan, Province Of China
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Phone
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+886975366364
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Hsin-I Tsai
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Address
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Chang Gung Memorial Hospital
No. 5 Fuxing Street, Gueishan county
Taoyuan, Taiwan, 333
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Country
103463
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Taiwan, Province Of China
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Phone
103463
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+886975366364
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Fax
103463
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Email
103463
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[email protected]
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Contact person for scientific queries
Name
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Dr Hsin-I Tsai
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Address
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Chang Gung Memorial Hospital
No. 5 Fuxing Street, Gueishan county
Taoyuan, Taiwan, 333
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Country
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Taiwan, Province Of China
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Phone
103464
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+886975366364
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Fax
103464
0
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Email
103464
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data underlying published results only will be shared
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When will data be available (start and end dates)?
The data will be available immediately following publication, no end date
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Available to whom?
The data will be available upon request to only researchers who provide a methodologically sound proposal
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Available for what types of analyses?
Data will only be available to achieve the aims in the approved proposal
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How or where can data be obtained?
access subject to approvals by Principal Investigator (
[email protected]
)
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
8372
Ethical approval
380101-(Uploaded-30-06-2020-18-56-51)-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
No additional documents have been identified.
Download to PDF