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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
Date results information 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] 291444 0
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 315281 0
Analgesia following liver resection 315282 0
Condition category
Condition code
Surgery 313577 313577 0 0
Surgical techniques
Anaesthesiology 313578 313578 0 0
Pain management
Oral and Gastrointestinal 313579 313579 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 313580 313580 0 0
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] 316136 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322034 0
The primary outcome was cumulative oral morphine equivalent daily dose in milligrams (oMEDD) on post operative Day 1.
Timepoint [1] 322034 0
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] 377101 0
Postoperative pain scores measured immediately postoperative in the post anaesthesia recovery unit
Timepoint [1] 377101 0
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] 377102 0
Postoperative pain scores on postoperative Day 1
Timepoint [2] 377102 0
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] 377103 0
Postoperative pain scores on postoperative Day 2
Timepoint [3] 377103 0
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 [4] 377104 0
Length of hospital stay (LOS) will be collected from the patient's hospital electronic medical record.
Timepoint [4] 377104 0
LOS will be determined by the period from completion of surgery to discharge
Secondary outcome [5] 377105 0
Time to full ward diet
Timepoint [5] 377105 0
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] 377106 0
Time to first oral opioid use
Timepoint [6] 377106 0
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] 377107 0
Any postoperative complication as a composite outcome
Timepoint [7] 377107 0
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] 377121 0
Costs related to the index hospital admission and any consequent readmission within 30 postoperative days.
Timepoint [8] 377121 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15277 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 28587 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 295911 0
Hospital
Name [1] 295911 0
Austin Health
Address [1] 295911 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC, 3084
Country [1] 295911 0
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] 294785 0
None
Name [1] 294785 0
Address [1] 294785 0
Country [1] 294785 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297192 0
Austin Health Research Ethics Commitee
Ethics committee address [1] 297192 0
Level 8 Harold Stokes Building 145 Studley Road Heidelberg Victoria Australia 3084
Ethics committee country [1] 297192 0
Australia
Date submitted for ethics approval [1] 297192 0
18/01/2018
Approval date [1] 297192 0
25/01/2018
Ethics approval number [1] 297192 0
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 73290 0
A/Prof Laurence Weinberg
Address 73290 0
Department of Anaesthesia, Austin Health, 145 Studley Road Heidelberg VIC 3084
Country 73290 0
Australia
Phone 73290 0
+61 394965000
Fax 73290 0
+61 394966421
Email 73290 0
laurence.weinberg@austin.org.au
Contact person for public queries
Name 73291 0
A/Prof Laurence Weinberg
Address 73291 0
Department of Anaesthesia, Austin Health, 145 Studley Road Heidelberg VIC 3084
Country 73291 0
Australia
Phone 73291 0
+61 394965000
Fax 73291 0
+61 394966421
Email 73291 0
laurence.weinberg@austin.org.au
Contact person for scientific queries
Name 73292 0
A/Prof Laurence Weinberg
Address 73292 0
Department of Anaesthesia, Austin Health, 145 Studley Road Heidelberg VIC 3084
Country 73292 0
Australia
Phone 73292 0
+61 394965000
Fax 73292 0
+61 394966421
Email 73292 0
laurence.weinberg@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patients have not consented to sharing of their data
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5791 0
Ethical approval
Citation [1] 5791 0
Link [1] 5791 0
Email [1] 5791 0
Laurence.weinberg@austin.org.au
Other [1] 5791 0
Attachment [1] 5791 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