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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
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
Secondary ID [1] 301657 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
open liver surgery 318086 0
postoperative pain 318087 0
Condition category
Condition code
Anaesthesiology 316114 316114 0 0
Pain management
Oral and Gastrointestinal 318868 318868 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 321261 0
Not applicable
Comparator / control treatment
Control group received IV-PCA only for pain control postoperatively
Control group
Dose comparison

Outcomes
Primary outcome [1] 324301 0
total morphine consumption at the end of day 3 postoperatively would be obtained from PCA unit
Timepoint [1] 324301 0
within the first three postoperative days
Primary outcome [2] 324302 0
Subjective pain score at rest and on movement, according to the patient. 5 being the worst pain and 1 being minimal pain.
Timepoint [2] 324302 0
Daily during the first three postoperative days
Secondary outcome [1] 384279 0
A review of patients' medical records were reviewed, in particularly, on what postoperative day were nasogastric tube and urinary catheter removed from the patients.
Timepoint [1] 384279 0
during hospital admission
Secondary outcome [2] 384280 0
A review of patients' medical records were reviewed, in particularly, on what postoperative day the patients started on fluid and soft diet.
Timepoint [2] 384280 0
During hospital admission

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Laparoscopic liver surgeries

Study design
Purpose
Duration
Selection
Timing
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22706 0
Taiwan, Province Of China
State/province [1] 22706 0
Taoyuan

Funding & Sponsors
Funding source category [1] 306091 0
Self funded/Unfunded
Name [1] 306091 0
Hsin-I Tsai
Address [1] 306091 0
Chang Gung Memorial Hospital
No. 5 Fuxing Street, Gueishan county
Taoyuan, Taiwan, 333
Country [1] 306091 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Chang Gung Memorial Hospital, Linkou
Address
No. 5 Fuxing Street, Gueishan county
Taoyuan, Taiwan, 333
Country
Taiwan, Province Of China
Secondary sponsor category [1] 306570 0
Individual
Name [1] 306570 0
Hsin I Tsai
Address [1] 306570 0
Chang Gung Memorial Hospital
No. 5 Fuxing Street, Gueishan county
Taoyuan, Taiwan, 333
Country [1] 306570 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306311 0
Chang Gung Memorial Hospital IRB
Ethics committee address [1] 306311 0
Chang Gung Memorial Hospital
No. 5 Fuxing Street, Gueishan county
Taoyuan, Taiwan, 333
Ethics committee country [1] 306311 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 306311 0
23/03/2020
Approval date [1] 306311 0
02/04/2020
Ethics approval number [1] 306311 0
202000571B0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103462 0
Dr Hsin-I Tsai
Address 103462 0
Chang Gung Memorial Hospital
No. 5 Fuxing Street, Gueishan county
Taoyuan, Taiwan, 333
Country 103462 0
Taiwan, Province Of China
Phone 103462 0
+886975366364
Fax 103462 0
Email 103462 0
tsaic@hotmail.com
Contact person for public queries
Name 103463 0
Dr Hsin-I Tsai
Address 103463 0
Chang Gung Memorial Hospital
No. 5 Fuxing Street, Gueishan county
Taoyuan, Taiwan, 333
Country 103463 0
Taiwan, Province Of China
Phone 103463 0
+886975366364
Fax 103463 0
Email 103463 0
tsaic@hotmail.com
Contact person for scientific queries
Name 103464 0
Dr Hsin-I Tsai
Address 103464 0
Chang Gung Memorial Hospital
No. 5 Fuxing Street, Gueishan county
Taoyuan, Taiwan, 333
Country 103464 0
Taiwan, Province Of China
Phone 103464 0
+886975366364
Fax 103464 0
Email 103464 0
tsaic@hotmail.com

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)?
The data will be available immediately following publication, no end date
Available to whom?
The data will be available upon request to only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Data will only be available to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator (tsaic@hotmail.com)
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 8372 0
Ethical approval
Citation [1] 8372 0
Link [1] 8372 0
Email [1] 8372 0
Other [1] 8372 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Although epidural group required substantially less morphine over the first 3 postoperative days than IV-PCA and IV-PCA + NBs groups, pain assessment by NRS scores were comparable among the three groups on postoperative day 1, 2 and 3 both at rest and on movement. Overall postoperative outcomes were not significantly different based on method of analgesia after adjusting for preoperative factors including the extent of hepatic resection. Therefore, IV-PCA + NB appeared to be an adequate alternative to epidural analgesia for postoperative pain control in patients receiving open liver resections.