ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000001998

Ethics application status

Approved

Date submitted

21/11/2019

Date registered

8/01/2020

Date last updated

8/01/2020

Date data sharing statement initially provided

8/01/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Intrathecal analgesia in patients undergoing major hepatobiliary surgery

Scientific title

Intrathecal analgesia in patients undergoing major hepatobiliary surgery: a retrospective study

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1194-2436

Trial acronym

Not applicable

Linked study record

Not applicable

Health condition

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

Liver resection

Analgesia following liver resection

Condition category

Condition code

Surgery

Surgical techniques

Anaesthesiology

Pain management

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Cancer

Liver

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This is a retrospective analysis of morphine use and pain scores in adult patients who underwent major open liver resection between July 2010 and June 2017 using a standardized enhanced recovery after surgery protocol. All patients underwent surgery at the Austin Hospital, a university hospital in Melbourne, Australia with a dedicated high volume hepato-pancreatic-biliary and liver transplant centre. Eligible patients were identified by International Statistical Classification of Diseases (ICD) codes that included the following surgical categories:
i.) excision of lesion of liver,
ii.) segmental resection of liver,
iii.) lobectomy of liver,
iv.) trisegmental resection of liver, and
v.) segmental resection of liver for trauma.

Patients were followed-up until hospital discharge for from the index admission.As this is a retrospective study, there is no patient involvement.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The primary outcome was cumulative oral morphine equivalent daily dose in milligrams (oMEDD) on post operative Day 1.

Timepoint [1]

Oral morphine equivalent daily dose in milligrams amounts will be collected from the patient's hospital electronic medical record. Oral morphine equivalent will be calculated using the Opioid Dose Equivalence document endorsed by the Faculty of Pain Medicine, Australian and New Zealand College of Anaesthetists

Secondary outcome [1]

Postoperative pain scores measured immediately postoperative in the post anaesthesia recovery unit

Timepoint [1]

Daily postoperative pain scores will be measured using the Numerical Rating Scale (NRS). The NRS is a single 11-point numeric scale in which a respondent selects a whole number (integers from 0 to 10) that best reflects the intensity of their pain. A score of 0 indicates no pain, whereas a score of 10 indicates extreme or the worst pain imaginable

Secondary outcome [2]

Postoperative pain scores on postoperative Day 1

Timepoint [2]

Postoperative pain scores will be measured using the Numerical Rating Scale (NRS). The NRS is a single 11-point numeric scale in which a respondent selects a whole number (integers from 0 to 10) that best reflects the intensity of their pain. A score of 0 indicates no pain, whereas a score of 10 indicates extreme or the worst pain imaginable

Secondary outcome [3]

Postoperative pain scores on postoperative Day 2

Timepoint [3]

Secondary outcome [4]

Length of hospital stay (LOS) will be collected from the patient's hospital electronic medical record.

Timepoint [4]

LOS will be determined by the period from completion of surgery to discharge

Secondary outcome [5]

Time to full ward diet

Timepoint [5]

Time to full ward diet will be defined as the period from completion of surgery to the first mention of tolerating full ward diet in the patient medical records.

Secondary outcome [6]

Time to first oral opioid use

Timepoint [6]

Time to first oral opioid use will be collected from the patient's hospital electronic medical record.. This will be defined as the period from completion of surgery to the first administration of oral opioid after surgery.

Secondary outcome [7]

Any postoperative complication as a composite outcome

Timepoint [7]

Complications will be defined as any deviation from the normal postoperative course, guided by the European Perioperative Clinical Outcome definitions. Complications were recorded by two independent clinicians, and then graded using Clavien-Dindo Classification - a widely used and validated approach to surgical outcome assessment that assigns severity grades to surgical complications.

Secondary outcome [8]

Costs related to the index hospital admission and any consequent readmission within 30 postoperative days.

Timepoint [8]

Raw costing data will be obtained from the hospital’s business intelligent unit, and then allocated into categories based on individual itemisation codes for costs incurred during admission. These categories will include:
1. intensive care unit costs
2. allied health costs
3. pathology costs
4. blood products costs
5. radiology costs
6. pharmacy costs
7. ward cost
8. theatre costs

Only in-hospital costs will be considered.

Eligibility

Key inclusion criteria

All adult patients who underwent surgery at Austin hospital in Melbourne, Eligible patients were identified by International Statistical Classification of Diseases (ICD) codes that included the following surgical categories: i.) excision of lesion of liver, ii.) segmental resection of liver, iii.) lobectomy of liver, iv.) trisegmental resection of liver, and v.) segmental resection of liver for trauma.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

We will excluded patients with a history of chronic opioid use (defined as near-daily use of >60 mg oral morphine equivalent) for 8 weeks or longer and patients receiving epidural analgesia.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Retrospective

Statistical methods / analysis

For the primary and the key secondary outcomes we will use quantile regression model-ling adjusted for the following priori defined covariates: major resection, patient age, Charlston Comorbidity Index, duration of surgery, and intraoperative oMEDD use. Standard assessment of collinearity will be conducted using variance inflation factors and condition number. For all other outcomes, continuous data will be summarized as medians and interquartile range ) and compared using the Mann-Whitney U test. Categorical variables will be summarized as counts (proportions) and compared using the chi-squared test or Fisher’s Exact test, as appropriate. Statistical analysis was performed using commercial statistical software.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

26/01/2018

Date of last participant enrolment

Anticipated

Actual

26/10/2018

Date of last data collection

Anticipated

Actual

8/12/2018

Sample size

Target

335

Accrual to date

Final

335

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Health

Address [1]

Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC, 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC, 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Research Ethics Commitee

Ethics committee address [1]

Level 8 Harold Stokes Building 145 Studley Road Heidelberg Victoria Australia 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/01/2018

Approval date [1]

25/01/2018

Ethics approval number [1]

HREC no: LNR/18/Austin/79

Summary

Brief summary

The purpose of this study is to identify the time point of peak serum potassium levels during the reperfusion phase of adult liver transplantation. We aim to assess the the changes in blood potassium levels from baseline values during reperfusion, and evaluate clinical factors that may be associated with the development of hyperkalaemia.

Who is it for?

The study will include adult patients undergoing liver resection surgery. This is a retrospective study to test the hypothesis that the addition of intrathecal morphine (ITM) results in reduced postoperative opioid use and enhanced postoperative analgesia in patients undergoing open liver resection using a standardized enhanced recovery after surgery (ERAS) protocol with multimodal analgesia.

Study details

The aim of this study is to quantify the cumulative oral morphine equivalent daily dose in milligrams (oMEDD) in the postoperative period and evaluate maximum pain scores at rest and on movement after surgery.   In addition, we will highlight the importance of using intrathecal morphine in patients undergoing liver resection.

It is hoped that this study will be hypothesis generating and provide valuable data for power calculations for future studies on evaluating the use of intrathecal morphine in patients undergoing liver resection surgery.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Laurence Weinberg

Address

Department of Anaesthesia, Austin Health, 145 Studley Road Heidelberg VIC 3084

Country

Australia

Phone

+61 394965000

Fax

+61 394966421

[email protected]

Contact person for public queries

Name

Laurence Weinberg

Address

Department of Anaesthesia, Austin Health, 145 Studley Road Heidelberg VIC 3084

Country

Australia

Phone

+61 394965000

Fax

+61 394966421

[email protected]

Contact person for scientific queries

Name

Laurence Weinberg

Address

Department of Anaesthesia, Austin Health, 145 Studley Road Heidelberg VIC 3084

Country

Australia

Phone

+61 394965000

Fax

+61 394966421

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Patients have not consented to sharing of their data

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5791	Ethical approval			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Intrathecal morphine is associated with reduction in postoperative opioid requirements and improvement in postoperative analgesia in patients undergoing open liver resection.	2020	https://dx.doi.org/10.1186/s12871-020-01113-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically