Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000350224
Ethics application status
Approved
Date submitted
26/04/2009
Date registered
25/05/2009
Date last updated
10/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of depth of volatile general anaesthesia, measured by bispectral index (BIS), on post-operative pain.
Scientific title
The effects of depth of volatile general anaesthesia, measured by bispectral index (BIS), on post-operative pain.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent post-operative pain. For the purpose of our study, persistent pain is defined as pain in the first 3-6 months after surgery. 4663 0
Early post-operative pain. For the purpose of our study, early post-operative pain is defined as pain in the first 24 to 48 hours after surgery. 4664 0
Condition category
Condition code
Anaesthesiology 4970 4970 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment group will receive deeper planes of volatile general anaesthesia for the duration of surgery with a bispectral index (BIS) targeted at 30-40. (ie the dose of volatile general anaesthesia will be titrated to the BIS)
Intervention code [1] 4429 0
Treatment: Other
Comparator / control treatment
The control group will receive volatile general anaesthesia for the duration of surgery with a bispectral index (BIS) of 50-60. (ie the dose of volatile general anaesthesia will be titrated to the BIS)
Control group
Dose comparison

Outcomes
Primary outcome [1] 5821 0
Our primary aim is to determine whether depth of volatile general anaesthesia, as measured by BIS, influences early post-operative pain scores and analgesic requirements in patients undergoing elective surgery.
Timepoint [1] 5821 0
Visual analogue pain score, patient controlled analgesia morphine consumption and incidence of nausea and vomiting will be assessed daily from days 0 to 2 post-operatively.
Secondary outcome [1] 241822 0
The secondary aim of our study is to assess whether depth of volatile general anaesthesia, as measured by BIS, influences persistent post-operative pain.
Timepoint [1] 241822 0
A functional assessment of persistent pain, analgesic requirements and limitations of activities of daily living will occur through a single telephone call at 3 months post-operatively and again at 6 months post-operatively.

Eligibility
Key inclusion criteria
Patients scheduled for elective surgery with a non-malignant diagnosis, aged 18-65 years, American Society of Anaesthesiologists score (ASA) 1 or 2, competent to consent to participation, able to use and visual analogue scale (VAS) and able to activate a patient controlled analgesia (PCA) machine post-operatively.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Emergency surgery
Age greater than 65 years
Age less than 18 years.
ASA 3 or above.
Inability to consent or lack of written consent
Inability to speak English fluently
Malignancy diagnosed or suspected pre-operatively
Epilepsy, neuromuscular disease, psychiatric illness or COPD with carbon dioxide retention
Pre-operative chronic opioid use
Morphine allergy, allergy to drugs used as part of the standardised general anaesthetic, history of malignant hyperthermia
Use of regional anaesthesia or neuraxial blockade (or request for regional anaesthesia by patient)
Use of TIVA rather than volatile general anaesthesia
Protocol broken intra-operatively (or post-operatively)
Return to theatre for re-operation within 48 hours
Pregnancy
Severe asthma
Expected duration of surgery > 3 hours (180 minutes)
Obesity (Weight > 120kg or body mass index (BMI) >35 kg/m2)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Pre-operatively a verbal explanation and a written information sheet will be given to patients including a description of the pain assessment tools and patient controlled analgesia (PCA) device to be used post-operatively. Pre-operative written informed consent will be obtained for all study participants. Consenting participants will then undergo block randomisation via sealed opaque envelope to be opened by the participant’s anaesthetist prior to surgery. Participants will be randomised to either treatment or control protocol pre-operatively.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 1740 0
New Zealand
State/province [1] 1740 0
Auckland and Waikato

Funding & Sponsors
Funding source category [1] 4851 0
Self funded/Unfunded
Name [1] 4851 0
University of Auckland.
Country [1] 4851 0
Funding source category [2] 256263 0
Charities/Societies/Foundations
Name [2] 256263 0
Australian and New Zealand College of Anaesthetists (ANZCA).
Country [2] 256263 0
Australia
Funding source category [3] 256264 0
Commercial sector/Industry
Name [3] 256264 0
Aspect Medical Ltd
Country [3] 256264 0
New Zealand
Funding source category [4] 256265 0
Commercial sector/Industry
Name [4] 256265 0
Safersleep Ltd
Country [4] 256265 0
New Zealand
Primary sponsor type
Individual
Name
Dr Matthew Scott
Address
Department of Anaesthesia, Nelson-Marlborough District Health Board, Nelson Hospital, Private Bag 18, Tipahi Street, Nelson, New Zealand.
Country
New Zealand
Secondary sponsor category [1] 4388 0
Individual
Name [1] 4388 0
Dr Michal Kluger
Address [1] 4388 0
Department of Anaesthesiology and Perioperative Medicine
North Shore Hospital
Private Bag 93-503
Takapuna, North Shore City 0740
Country [1] 4388 0
New Zealand
Other collaborator category [1] 653 0
Individual
Name [1] 653 0
Professor Jamie Sleigh
Address [1] 653 0
Waikato Clinical School of the University of Auckland
Waikato Hospital
Pembroke Street
Private Bag 3200
Hamilton 3240
Country [1] 653 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6908 0
Northern X Regional Ethics Committee
Ethics committee address [1] 6908 0
3rd Floor, Unisys Building,
650 Great South Road, Penrose
Auckland 1061
Private Bag 92-522, Wellesley Street, Auckland
Ethics committee country [1] 6908 0
New Zealand
Date submitted for ethics approval [1] 6908 0
14/05/2009
Approval date [1] 6908 0
19/11/2009
Ethics approval number [1] 6908 0
NTX/09/06/047

Summary
Brief summary
Recent studies have shown that the amount of general anaesthesia administered during an operation may influence pain and pain relief needed after surgery. We plan to use a brain monitor called bispectral index (BIS) to investigate a possible relationship between general anaesthesia and pain after surgery. We also plan to further investigate whether differing intensity of post-operative pain is influenced by either different genetic sensitivity to pain, or the body excreting fentanyl more quickly.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29534 0
Address 29534 0
Country 29534 0
Phone 29534 0
Fax 29534 0
Email 29534 0
Contact person for public queries
Name 12781 0
Dr Matthew Scott
Address 12781 0
Department of Anaesthesia, Nelson-Marlborough District Health Board, Nelson Hospital, Private Bag 18, Tipahi Street, Nelson, New Zealand.
Country 12781 0
New Zealand
Phone 12781 0
+64 2 168 5051
Fax 12781 0
Email 12781 0
[email protected]
Contact person for scientific queries
Name 3709 0
Professor Jamie Sleigh
Address 3709 0
Waikato Clinical School of the University of Waikato Hospital
Pembroke Street
Private Bag 3200
Hamilton 3240
Country 3709 0
New Zealand
Phone 3709 0
+64 7 839 8899
Fax 3709 0
+64 7 839 8761
Email 3709 0
[email protected]

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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3910Plain language summaryNo Results. The results of this study showed no signi... [More Details]
4253Study results articleYes 83855-(Uploaded-02-07-2019-10-56-50)-Journal results publication.pdf

Documents added automatically
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