Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000714987
Ethics application status
Approved
Date submitted
6/05/2020
Date registered
1/07/2020
Date last updated
1/07/2020
Date data sharing statement initially provided
1/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
To compare types of anaesthetics for patients having elective laparoscopic surgery
Scientific title
Comparison of recovery after surgery between opioid and opioid-free anaesthesia for elective laparoscopic abdominal surgery
Secondary ID [1] 301202 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elective laparoscopic abdominal surgery 317349 0
Condition category
Condition code
Anaesthesiology 315456 315456 0 0
Anaesthetics
Reproductive Health and Childbirth 315769 315769 0 0
Contraception
Oral and Gastrointestinal 315770 315770 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention (Arm B) will receive opioid-free anaesthesia during laparascopic surgery
Opioid Free Anaesthesia induction
Anxiolytic agent: 1 minute prior to induction Midazolam 1 – 3mg intravenously
Clonidine 1-3mcg/kg intravenously in 3 divided doses (at induction, mid surgery and end)
Rapid stress block: Lidocaine as per local protocols.
Induction hypnotic drug:
Propofol 1 – 2.5mg/kg intravenously bolus or as per programmed Target Control Infusion
Rapid preload reduction:
Magnesium sulphate 40 mg / kg (according to patient ideal body weight )
Anti-inflammatory agents :
Single dose perioperatively of Intravenous Dexamethasone 8 mg and Parecoxib 40mg intravenously.
Neuromuscular blocker (if needed for anaesthesia or surgery): Choice of any neuromuscular blocker is at the anaesthetist’s discretion.
Beta-blocker: Esmolol 10 – 50mg IV bolus 20 seconds prior to intubation
On standby intravenous bolus medications as required for hypotension;
Ephedrine 3 mg/mL
Phenylephrine 100mcg/mL
Metaraminol 0.5mg/mL

All perioperative drugs administered will be audited at day 1 post surgery with the patient total oral morphine equivalent daily dose (oMEDD) calculated.
Intervention code [1] 317504 0
Treatment: Drugs
Comparator / control treatment
Arm 1 (control) will receive standard anaesthesia during laparoscopic surgery as per local hospital policy.
Control group
Active

Outcomes
Primary outcome [1] 323702 0
Quality of recovery (qoR)-15 score
Timepoint [1] 323702 0
Day 1 post-op
Secondary outcome [1] 382653 0
Post operative complications including delirium/hallucinations (yes or no) and urinary complications (retention requiring indwelling catheter yes/no) using the post anaesthetic recovery room documents and analgesia monitoring forms.
Timepoint [1] 382653 0
Assessed for a maximum of 1 day post-op.
Secondary outcome [2] 383139 0
Length-of-stay from admittance to theatre until discharge from the postoperative unit from medical record.
Timepoint [2] 383139 0
Discharge from the perioperative unit
Secondary outcome [3] 383140 0
Post-operative nausea and vomiting 0=No PONV, 1=mild, 2=moderate and 3=severe using State-wide Queensland Health Analgesia Monitoring Form,
Timepoint [3] 383140 0
Assessed for a maximum of 1 day post-op.
Secondary outcome [4] 383147 0
Time to first opioid and analgesia use. Time taken from admittance to the post-operative care unit and recorded using the analgesia monitoring form.
Timepoint [4] 383147 0
Assessed for a maximum of 1 day post-op.
Secondary outcome [5] 383475 0
Length-of-stay from admittance to theatre until discharge from the hospital derived from medical record.
Timepoint [5] 383475 0
Time of discharge from hospital following surgery.
Secondary outcome [6] 383476 0
Oral Morphine Equivalent Daily Dose calculated from patient medical record.
Timepoint [6] 383476 0
Assessed for a week prior to surgery, and day 1 post-op.

Eligibility
Key inclusion criteria
Patients may be included in the study only if they meet all of the following criteria:
• Aged 18 - 65 years
• Independent capacity to consent to participate in trial
• American Society of Anaesthesiologists (ASA) physical health score of I - II
• Booked for elective laparoscopic cholecystectomy or tubal ligation (with or without oophorectomy)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who fulfil any of the following criteria are not eligible for admission to the study:
• Pregnant women
• Body Mass Index > 35
• Allergy to opioids
• Allergy to adjuvant drugs
• Persistent opioid use - patients with Oral Morphine Equivalent Daily Dose (OMEDD) greater than 0 during previous week pre-op and taken for 7 successive days or more including recreational drug use.
• Non-elective surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment allocations will be randomised into blocks of 6 and stratified by type of surgery (tubal ligation or cholecystectomy) using computer generated sequencing.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All participants randomized will be included in the analyses on an intention-to-treat basis.
All data will be cleaned and examined for distribution and dispersion to assess distributional assumptions and relationships. Descriptive statistics including frequencies, percentages for categorical data with means, standard deviations or medians, ranges for continuous data, will be assessed to ensure randomisation has succeeded and to describe differences between groups.
Total and mean QoR-15 scores will be calculated per patient at baseline and on day 1. QoR-15 change scores will be calculated to determine the difference between day 1 and baseline scores for each patient.
The effect of OFA versus non-OFA on recovery (QoR-15 score) will be assessed using a mixed model with random effects (of individual patients) to compare and determine the effect of OFA on QoR-15 scores across time, accounting for baseline QoR-15 scores, type of surgery and change in time. If there are no statistically significant random effects in the mixed method model (tested using likelihood ratio test) univariate and multivariate linear regression models using the QoR-15 change score will be used for group comparisons and to estimate factors associated with outcomes. Confounders, variables modifiers and biases will be identified, eliminated were possible, or appropriately dealt with through data transformation and the inclusion of interaction terms in the models.
Stata 14 (Statacorp, Texas) and SPSS® version 20.0 (IBM® SPSS® Statistics 20) for Windows will be used for all analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2020
Actual
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
1/07/2021
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16606 0
Bundaberg Hospital - Bundaberg
Recruitment postcode(s) [1] 30203 0
4670 - Bundaberg

Funding & Sponsors
Funding source category [1] 305652 0
Hospital
Name [1] 305652 0
Wide Bay Hospital and Health Service
Country [1] 305652 0
Australia
Primary sponsor type
Hospital
Name
Wide Bay Hospital and Health Service
Address
Bundaberg Hospital,
271 Bourbong St,
Bundaberg Central
QLD 4670
Country
Australia
Secondary sponsor category [1] 306059 0
None
Name [1] 306059 0
Address [1] 306059 0
Country [1] 306059 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305935 0
Royal Brisbane and Womens Hospital Human Research Committee
Ethics committee address [1] 305935 0
Human Research Ethics Office
Lower Ground Floor, Executive Offices
James Mayne Building,
Butterfield Street
Herston QLD 4029
Ethics committee country [1] 305935 0
Australia
Date submitted for ethics approval [1] 305935 0
06/05/2020
Approval date [1] 305935 0
10/06/2020
Ethics approval number [1] 305935 0
HREC/2020/QRBW/62398

Summary
Brief summary
Opioids are routinely used during surgery however opioids are associated with a range of side effects. As an alternative, opioid-free anaesthesia (OFA) is an emerging mode of anaesthesia intended to avoid these side effects.
This study will utilise a randomised clinical trial to investigate the impact of OFA for patients having an elective laparoscopic cholecystectomy or tubal ligation. Patient outcomes to be measured include:
• Quality of Recovery (QoR-15);
• Oral Morphine Equivalent Daily Dose (OMEDD) at 24 hours post operatively;
• Time to first opioid (TTFO) dose;
• Post-operative nausea and vomiting (PONV);
• Post Anaesthetic Care Unit (PACU) Length of stay (LOS); and
• Hospital Length of stay (LOS).
Trial website
none
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 102126 0
Dr Anthony Eidan
Address 102126 0
Bundaberg Hospital,
271 Bourbong St,
Bundaberg Central
QLD 4670
Country 102126 0
Australia
Phone 102126 0
+61 7 41502222
Fax 102126 0
Email 102126 0
[email protected]
Contact person for public queries
Name 102127 0
Dr Anthony Eidan
Address 102127 0
Bundaberg Hospital,
271 Bourbong St,
Bundaberg Central
QLD 4670
Country 102127 0
Australia
Phone 102127 0
+61 7 41502222
Fax 102127 0
Email 102127 0
[email protected]
Contact person for scientific queries
Name 102128 0
Dr Anthony Eidan
Address 102128 0
Bundaberg Hospital,
271 Bourbong St,
Bundaberg Central
QLD 4670
Country 102128 0
Australia
Phone 102128 0
+61 7 41502222
Fax 102128 0
Email 102128 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
None


What supporting documents are/will be available?

No Supporting Document Provided



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.