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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 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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

open liver surgery

postoperative pain

Condition category

Condition code

Anaesthesiology

Pain management

Oral and Gastrointestinal

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]

Not applicable

Comparator / control treatment

Control group received IV-PCA only for pain control postoperatively

Control group

Dose comparison

Outcomes

Primary outcome [1]

total morphine consumption at the end of day 3 postoperatively would be obtained from PCA unit

Timepoint [1]

within the first three postoperative days

Primary outcome [2]

Subjective pain score at rest and on movement, according to the patient. 5 being the worst pain and 1 being minimal pain.

Timepoint [2]

Daily during the first three postoperative days

Secondary outcome [1]

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]

during hospital admission

Secondary outcome [2]

A review of patients' medical records were reviewed, in particularly, on what postoperative day the patients started on fluid and soft diet.

Timepoint [2]

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

Sex

Both males and females

Can healthy volunteers participate?

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

2/04/2020

Date of last participant enrolment

Anticipated

Actual

2/04/2020

Date of last data collection

Anticipated

Actual

2/04/2020

Sample size

Target

266

Accrual to date

Final

243

Recruitment outside Australia

Country [1]

Taiwan, Province Of China

State/province [1]

Taoyuan

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Hsin-I Tsai

Address [1]

Chang Gung Memorial Hospital No. 5 Fuxing Street, Gueishan county Taoyuan, Taiwan, 333

Country [1]

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]

Individual

Name [1]

Hsin I Tsai

Address [1]

Chang Gung Memorial Hospital No. 5 Fuxing Street, Gueishan county Taoyuan, Taiwan, 333

Country [1]

Taiwan, Province Of China

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Chang Gung Memorial Hospital IRB

Ethics committee address [1]

Chang Gung Memorial Hospital
No. 5 Fuxing Street, Gueishan county
Taoyuan, Taiwan, 333

Ethics committee country [1]

Taiwan, Province Of China

Date submitted for ethics approval [1]

23/03/2020

Approval date [1]

02/04/2020

Ethics approval number [1]

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

Dr Hsin-I Tsai

Address

Chang Gung Memorial Hospital No. 5 Fuxing Street, Gueishan county Taoyuan, Taiwan, 333

Country

Taiwan, Province Of China

Phone

+886975366364

Fax

[email protected]

Contact person for public queries

Name

Hsin-I Tsai

Address

Chang Gung Memorial Hospital No. 5 Fuxing Street, Gueishan county Taoyuan, Taiwan, 333

Country

Taiwan, Province Of China

Phone

+886975366364

Fax

[email protected]

Contact person for scientific queries

Name

Hsin-I Tsai

Address

Chang Gung Memorial Hospital No. 5 Fuxing Street, Gueishan county Taoyuan, Taiwan, 333

Country

Taiwan, Province Of China

Phone

+886975366364

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• The data will be available upon request to only researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?

• Individual participant data underlying published results only will be shared

What types of analyses could be done with individual participant data?

• Data will only be available to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?

From:
The data will be available immediately following publication, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• access subject to approvals by Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8372	Ethical approval					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.

Trial Review

Documents added manually

Documents added automatically