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Trial registered on ANZCTR
Registration number
ACTRN12612000953831
Ethics application status
Approved
Date submitted
27/08/2012
Date registered
5/09/2012
Date last updated
21/01/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Can Heart Rate Variability analysis reduce analgesic requirements after laparoscopic cholecystectomy?
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Scientific title
A randomised controlled pilot trial comparing the effectiveness of intraoperative Acute Nociception Index (ANI) monitoring on reducing moderate-severe pain in the Postanaesthesia Care Unit (PACU) in patients having elective cholecystectomy.
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Secondary ID [1]
281101
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Nil
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Universal Trial Number (UTN)
U1111-1133-8409
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
cholecystectomy
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Condition category
Condition code
Anaesthesiology
287676
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Dose of intraoperative intravenous analgesia administration (morphine or fentanyl) based on measurement of autonomic tone using the Acute Nociception Index (ANI) monitor. The ANI monitor is a modified ECG monitor that uses a software algorthim to measure variation in the ECG R-R interval to generate an index for the patients autonomic tone. Dose ranges MORPHINE 3-5mg (give 5mg if ANI < 30), max cumulative dose 40mg (age<50), 30mg (age<75) OR FENTANYL 30-50mcg (give 50mcg if ANI < 30), max cumulative dose 400mcg (age<50), 300mcg (age<75)
Review ANI after 5 minutes and repeat bolus as above if ANI score remains below 50. Repeat after every 5 minutes until ANI score >50 (maximum morphine dose permitted 40mg if age<50, 30 mg if age 50-75- or fentanyl equivalent)
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Intervention code [1]
285555
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Treatment: Devices
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
Intervention group:, ANI score below 50:
a. MORPHINE 3-5mg (give 5mg if ANI < 30), max cumulative dose 40mg (age<50), 30mg (age<75)
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b. FENTANYL 30-50mcg (give 50mcg if ANI < 30), max cumulative dose 400mcg (age<50), 300mcg (age<75)
Review ANI every 5 minutes and bolus as per above.
Comparator group: usual practice. i.e. Intraoperative analgesia administration (morphine of fentanyl) in doses based on clinician experience and training, based on usual clinical practice (e.g. increase heart rate,increased blood pressure, etc). There are no protocols to guide this. Maximum doses as above.
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Control group
Active
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Outcomes
Primary outcome [1]
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Proportion with severe pain (Visual Analogue Scale >5 ) in PACU
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Assessment method [1]
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Timepoint [1]
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1 hour
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Secondary outcome [1]
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Sum of pain scores (Visual Analogue Scale) at 15, 30, 45 and 60 minutes in recovery room
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Assessment method [1]
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Timepoint [1]
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1 hour
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Secondary outcome [2]
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Total amount of rescue Morphine/Fentanyl protocol in PACU in mg. PACU opioid pain protocol is based on clinical assessment of patients pain i.e VAS score 3-5 give morphine 1mg, reassess after 5 minutes, VAS pain score >5 give 3mg morphine, reassess after 5 minutes.
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Assessment method [2]
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Timepoint [2]
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1 hour
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Eligibility
Key inclusion criteria
Elective laparoscopic cholecystectomy
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Minimum age
18
Years
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Maximum age
74
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Inability to obtain informed consent from patient
Cognitively impaired patients
Emergency cholecystectomy
Non-sinus rhythmn cardiac status
Known impairment of the autonomic nervous system
Pregnancy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible participant will be identified from the elective surgical operating list. Informed written consent will be sought from the patient on the day of surgery by an investigator, or by the anaesthetist / anaesthetic registrar.
Randomisation to a treatment group will be determined in advance (blocked random allocation) and concealed by means of sealed, opaque and tamper-proof envelopes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked random allocation by the trial statistician
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/10/2012
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Actual
1/10/2012
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Date of last participant enrolment
Anticipated
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Actual
9/09/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
120
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Peninsula Health
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Address [1]
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Hastings Rd
Frankston. VIC 3199
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Peninsula Health (Frankston Hospital)
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Address
Hastings Rd
Frankston VIC 3199
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
284712
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Peninsula Health HREC
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Ethics committee address [1]
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PO Box 52
Frankston VIC 3199
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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22/08/2012
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Approval date [1]
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03/09/2012
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Ethics approval number [1]
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HREC/12/PH/65
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Summary
Brief summary
This study investigates whether using a new pain monitoring device, the ANI monitor, can better predict how much pain-killing medication patients having keyhole gallbladder surgery need. During gallbladder removal patients are asleep and unaware but still need pain-killing medication such as morphine or fentanyl to make sure they are not in severe pain when you wake up.
Anaesthetist currently estimate how much pain-killing medication is needed based on factors including patient age, body weight, thepatients response to the surgery judged by blood pressure/heart rate monitoring and the anaesthetists clinical experience. Using these methods, patients sometimes wake up after surgery with severe pain because the prediction of dose for pain-killing medicine during surgery was incorrect.
In this study, we will be testing a new pain monitor which may be able to more accurately predict a patients analgesia requirements during surgery. This monitor requires two gel electrodes to be placed on your chest, alongside the gel electrodes that are put on by the anaesthetist for standard heart monitoring. It records heart rate with great accuracy and using complex mathematical formulas, generates a number (the acute nociception index) which may better predict the pain levels while the patient is anaesthetized.
This study compares the comfort of patients waking up after gallbladder surgery when the monitor is used compared with standard care.
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Trial website
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Trial related presentations / publications
J. A. Szental, A. Webb, C. Weeraratne, A. Campbell, H. Sivakumar, and S. Leong
Postoperative pain after laparoscopic cholecystectomy is not reduced by intraoperative analgesia guided by analgesia nociception index (ANI®) monitoring: a randomized clinical trial
Br. J. Anaesth. (2015) 114 (4): 640-645 first published online December 23, 2014 doi:10.1093/bja/aeu411
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Public notes
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Contacts
Principal investigator
Name
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Dr Joshua Szental
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Address
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Department of Anaesthesia
Peninsula Health
Frankston VIC 3199
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Country
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Australia
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Phone
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+61397847445
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Dr Ashley Webb
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Address
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Department of Anaesthesia
Peninsula Health
Hastings Rd
Frankston VIC 3199
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Country
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Australia
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Phone
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+61397847445
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Fax
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+61397847441
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Dr Ashley Webb
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Address
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Department of Anaesthesia
Peninsula Health
Hastings Rd
Frankston VIC 3199
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Country
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Australia
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Phone
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+61397847445
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Fax
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+61397847441
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Email
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[email protected]
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No information has been provided regarding IPD availability
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
Source
Title
Year of Publication
DOI
Embase
Postoperative pain after laparoscopic cholecystectomy is not reduced by intraoperative analgesia guided by analgesia nociception index (ANI) monitoring: A randomized clinical trial.
2015
https://dx.doi.org/10.1093/bja/aeu411
N.B. These documents automatically identified may not have been verified by the study sponsor.
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