ANZCTR - Registration

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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?

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.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1133-8409

Trial acronym

Linked study record

Health condition

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

cholecystectomy

Condition category

Condition code

Anaesthesiology

Pain management

Intervention/exposure

Study type

Interventional

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)

Intervention code [1]

Treatment: Devices

Intervention code [2]

Treatment: Drugs

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)
OR
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.

Control group

Active

Outcomes

Primary outcome [1]

Proportion with severe pain (Visual Analogue Scale >5 ) in PACU

Timepoint [1]

1 hour

Secondary outcome [1]

Sum of pain scores (Visual Analogue Scale) at 15, 30, 45 and 60 minutes in recovery room

Timepoint [1]

1 hour

Secondary outcome [2]

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.

Timepoint [2]

1 hour

Eligibility

Key inclusion criteria

Elective laparoscopic cholecystectomy

Minimum age

18 Years

Maximum age

74 Years

Sex

Both males and females

Can healthy volunteers participate?

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

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)

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.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Blocked random allocation by the trial statistician

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/10/2012

Actual

1/10/2012

Date of last participant enrolment

Anticipated

Actual

9/09/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

120

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Peninsula Health

Address [1]

Hastings Rd
Frankston. VIC 3199

Country [1]

Australia

Primary sponsor type

Hospital

Name

Peninsula Health (Frankston Hospital)

Address

Hastings Rd
Frankston VIC 3199

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peninsula Health HREC

Ethics committee address [1]

PO Box 52
Frankston VIC 3199

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/08/2012

Approval date [1]

03/09/2012

Ethics approval number [1]

HREC/12/PH/65

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.

Trial website

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

Public notes

Contacts

Principal investigator

Name

Dr Joshua Szental

Address

Department of Anaesthesia
Peninsula Health
Frankston VIC 3199

Country

Australia

Phone

+61397847445

Fax

jszental@gmail.com

Contact person for public queries

Name

Dr Ashley Webb

Address

Department of Anaesthesia
Peninsula Health
Hastings Rd
Frankston VIC 3199

Country

Australia

Phone

+61397847445

Fax

+61397847441

awebb@phcn.vic.gov.au

Contact person for scientific queries

Name

Dr Ashley Webb

Address

Department of Anaesthesia
Peninsula Health
Hastings Rd
Frankston VIC 3199

Country

Australia

Phone

+61397847445

Fax

+61397847441

awebb@phcn.vic.gov.au

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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Documents added manually

Documents added automatically