Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000628347
Ethics application status
Approved
Date submitted
20/03/2017
Date registered
1/05/2017
Date last updated
14/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of using multiple modes of pain-killers with less opioid on the pain level among surgical patients at high risk of undiagnosed obstructive sleep apnoea
Scientific title
Multimodal opioid-sparing analgesia in patients at high risk of obstructive sleep apnoea undergoing orthopaedic surgery: a prospective, randomised, controlled pilot study
Secondary ID [1] 291487 0
Nil known
Universal Trial Number (UTN)
U1111-1194-4449
Trial acronym
SPARRO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnoea 302556 0
Condition category
Condition code
Anaesthesiology 302087 302087 0 0
Anaesthetics
Respiratory 302229 302229 0 0
Sleep apnoea
Surgery 302230 302230 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Orthopaedic surgical patients who scored 5 or above in the STOP-BANG questionnaire will be recruited. They will be randomised into 2 arms.
Arm 1: conventional arm. Post-operative pain is managed using patient-controlled morphine and other non-opioid analgesics.
Arm 2: interventional arm. Post-operative pain is managed using peripheral nerve blocks, patient-controlled morphine and other non-opioid analgesics.

All peripheral nerve blocks will be administered by anaesthetists or anaesthetic trainee with more than 5 years' experience. The blocks will be performed in the operating theatre under ultrasound guidance, before the induction of general anaesthesia. The type of block administered depends on the type of orthopaedic surgery planned. The total dose of local anaesthetic will not exceed the recommended dose calculated from the patient's body weight (ropivacaine 3mg/kg or levo-bupivacaine 2mg/kg). The choice between ropivacaine or levo-bupivacaine depends on the anaesthetists' preference and availability of the drug.

Post-operatively all patients will receive oxygen supplement for 24 hours (facemask 5L/min in the recovery zone & nasal prong 3L/min in the ward). Unless contraindicated, all patients will be prescribed oral paracetamol 1g 6-hourly and oral celecoxib 200mg 12-hourly for 5 days in addition to the patient-controlled morphine. The patient-controlled morphine uses our standard hospital protocol (1mg per bolus of intravenous morphine, lock-out time of 5 minutes, maximum dose of 48mg per 4 hours, duration 1-3 days depending on patient's clinical condition).

The oxygen desaturation index (for both Arms) will be monitored for 3 consecutive nights. In addition, patients' morphine usage, pain score, sedation score, and length of hospital stay will be recorded.
Intervention code [1] 297554 0
Prevention
Intervention code [2] 297555 0
Treatment: Drugs
Comparator / control treatment
Arm 1 or the conventional arm will be the control treatment.
The patients will receive patient-controlled morphine and other non-opioid analgesics after surgery. The analgesic therapy will be managed as per standard patient care.

Similarly, the oxygen desaturation index, morphine usage, pain score, sedation score and length of hospital stay will be recorded.
Control group
Active

Outcomes
Primary outcome [1] 301523 0
Post-operative pain score. This is assessed using a pain-assessment ruler that combines the visual analog scale and numerical rating scale.
Timepoint [1] 301523 0
Post-operative Day 1 - Day 3. Based on the hospital protocol, the ward nurses assess pain score 4-6 hourly, while the acute pain service team assess patient daily. When a patient's pain score is more than 4, a doctor will be called to attend to the patient. All the pain score will be recorded in the acute pain service chart.
Secondary outcome [1] 332922 0
Post-operative morphine usage

This is recorded automatically in the patient-controlled analgesia machine and manually recorded in the acute pain service charts.
Timepoint [1] 332922 0
Post-operative Day 1 to Day 3

The total morphine usage is recorded daily in the acute pain service chart.
Secondary outcome [2] 332923 0
Post-operative oxygen desaturation index This will be measured using an oximetry watch.
Timepoint [2] 332923 0
Post-operative Day 1 to Day 3 The oximetry watch is applied for 3 consecutive nights, from 10pm to 7am.
Secondary outcome [3] 332924 0
Post-operative sedation score

This is assessed using the Pasero opioid-induced sedation scale (POSS), which is a standard tool for assessing the degree of sedation in patients receiving strong opioid.
Timepoint [3] 332924 0
Post-operative Day 1 to Day 3

Based on the hospital protocol, the ward nurses assess sedation score 4-6 hourly, while the acute pain service team assess patient daily. When a patient's sedation score is 3 or more (frequently drowsy), a doctor will be called to attend to the patient. All the sedation score will be recorded in the acute pain service chart.
Secondary outcome [4] 332925 0
Length of hospital stay

This is measured from the day of hospital admission to the day of discharge.
Timepoint [4] 332925 0
Post-surgery

Eligibility
Key inclusion criteria
Inclusion criteria
1) Aged 18 years old and above
2) STOPBANG score of 5 or more.
3) American Society of Anesthesiologist ASA 1 or 2
4) Patient is scheduled for a surgical procedure that is expected to:
-Undergo general anesthesia
-Post-operative analgesia can be achieved completely by regional nerve blocks.
-Remain hospitalized for at least 48 hours postoperatively
5) Orthopaedic surgery involving the upper limb (below shoulder) or lower limb (knee and below)[type of surgery that included]
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
1) Pregnant
2) ASA 3 and above
3) Patients who require post-operative ventilation
4) Diagnosed to have OSA and on night CPAP therapy
5) Contraindicated for peripheral nerve block (such as coagulopathy, allergic to local anaesthetics, and patient refusal)
6) Underlying irreversible respiratory disease
7) Postoperative analgesia of the procedure that cannot be achieved with up to two peripheral nerve blocks.
8) Require surgery in other part of the body

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)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study.
The mean and standard deviation from the first 20 recruited patients will be used to derive the sample size for this study. It will be done by power study, which is performed using web-based sample size calculator.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/05/2017
Actual
23/05/2017
Date of last participant enrolment
Anticipated
31/12/2017
Actual
1/11/2017
Date of last data collection
Anticipated
3/01/2018
Actual
4/11/2017
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 8749 0
Malaysia
State/province [1] 8749 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 295968 0
University
Name [1] 295968 0
University Malaya
Country [1] 295968 0
Malaysia
Primary sponsor type
Individual
Name
Lai Hou Yee
Address
Department of Anaesthesiology, University Malaya Medical Centre,
Lembah Pantai, 59100, Kuala Lumpur.
Country
Malaysia
Secondary sponsor category [1] 294854 0
Individual
Name [1] 294854 0
Chin Kim Hong
Address [1] 294854 0
Department of Anaesthesiology, University Malaya Medical Centre,
Lembah Pantai, 59100, Kuala Lumpur.
Country [1] 294854 0
Malaysia
Secondary sponsor category [2] 294856 0
Individual
Name [2] 294856 0
Chaw Sook Hui
Address [2] 294856 0
Department of Anaesthesiology, University Malaya Medical Centre,
Lembah Pantai, 59100, Kuala Lumpur.
Country [2] 294856 0
Malaysia
Secondary sponsor category [3] 294857 0
Individual
Name [3] 294857 0
Lee Pui Kuan
Address [3] 294857 0
Department of Anaesthesiology, University Malaya Medical Centre,
Lembah Pantai, 59100, Kuala Lumpur.
Country [3] 294857 0
Malaysia
Secondary sponsor category [4] 294858 0
Individual
Name [4] 294858 0
Ina Ismiarti Binti Shariffuddin
Address [4] 294858 0
Department of Anaesthesiology, University Malaya Medical Centre,
Lembah Pantai, 59100, Kuala Lumpur.
Country [4] 294858 0
Malaysia
Secondary sponsor category [5] 294859 0
Individual
Name [5] 294859 0
Wang Chew Yin
Address [5] 294859 0
Department of Anaesthesiology, University Malaya Medical Centre,
Lembah Pantai, 59100, Kuala Lumpur.
Country [5] 294859 0
Malaysia
Secondary sponsor category [6] 294860 0
Individual
Name [6] 294860 0
Chong Shu Juen
Address [6] 294860 0
Department of Anaesthesiology, University Malaya Medical Centre,
Lembah Pantai, 59100, Kuala Lumpur.
Country [6] 294860 0
Malaysia
Secondary sponsor category [7] 294861 0
Individual
Name [7] 294861 0
Frances Chung
Address [7] 294861 0
Department of Anaesthesia, University Health Network - Toronto Western Hospital
399, Bathurst Street, Toronto, ON M5T 2S8, Canada
Country [7] 294861 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297239 0
Medical Research Ethics Committee
Ethics committee address [1] 297239 0
University Malaya Medical Centre
Lembah Pantai, 59100 Kuala Lumpur
Ethics committee country [1] 297239 0
Malaysia
Date submitted for ethics approval [1] 297239 0
28/12/2016
Approval date [1] 297239 0
02/02/2017
Ethics approval number [1] 297239 0
2016111-4483

Summary
Brief summary
Obstructive sleep apnoea is a common problem. During sleep, some of us have occasional blockade of our breathing passage. This condition disturbs our sleep and makes us feel sleepy during the day.

People with sleep apnoea are at higher risk of breathing problems and low oxygen level after surgery, compared to those without. The use of sedative pain medications may make this worse.

Study hypothesis:
By using nerve block anaesthesia to control post-operative pain in patients at high risk of obstructive sleep apnoea, the use of sedative pain medications may be lower and the oxygen level may be better.

Study method:
All patients scheduled for orthopaedic surgeries will be interviewed by the anaesthetic doctors before the surgery. If they are at high risk of obstructive sleep apnoea, the doctor will invite them to participate in this study. Patients who agree to participate will be randomly assigned to the conventional arm or interventional arm.

A small machine will be strapped on their wrist, like a wrist watch, to monitor the oxygen level when they sleep. This is started on the night before the surgery and 3 nights after.

Patients in the interventional arm receive a nerve block anaesthesia before the surgery.

For both arms, general anaesthesia will be performed. Adequate pain relief will be given during and after the surgery. Patients will receive pain medications in the form of pills and from a machine that they control themselves. All patients receive oxygen for at least 24 hours. The anaesthetic doctor perform daily visit to monitor patients' condition.

Besides comparing the oxygen level, other aspects of post-operative care will also be monitored, including the morphine usage, pain score, sedation score and length of hospital stay.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1595 1595 0 0
/AnzctrAttachments/372592-OSA study protocol final.docx (Protocol)
Attachments [2] 1596 1596 0 0
/AnzctrAttachments/372592-ethics approval letter.pdf (Ethics approval)
Attachments [3] 1597 1597 0 0
/AnzctrAttachments/372592-Patient information sheet combined 1.doc (Participant information/consent)
Attachments [4] 1598 1598 0 0
/AnzctrAttachments/372592-Consent forms.doc (Participant information/consent)
Attachments [5] 1599 1599 0 0
/AnzctrAttachments/372592-CRF final.doc (Supplementary information)

Contacts
Principal investigator
Name 73426 0
Dr Lai Hou Yee
Address 73426 0
Department of Anaesthesiology, University Malaya Medical Centre,
Lembah Pantai, 59100 Kuala Lumpur, Malaysia.
Country 73426 0
Malaysia
Phone 73426 0
+60122880075
Fax 73426 0
Email 73426 0
[email protected]
Contact person for public queries
Name 73427 0
Dr Chin Kim Hong
Address 73427 0
Department of Anaesthesiology, University Malaya Medical Centre,
Lembah Pantai, 59100 Kuala Lumpur, Malaysia.
Country 73427 0
Malaysia
Phone 73427 0
+60127328600
Fax 73427 0
Email 73427 0
[email protected]
Contact person for scientific queries
Name 73428 0
Dr Lai Hou Yee
Address 73428 0
Department of Anaesthesiology, University Malaya Medical Centre,
Lembah Pantai, 59100 Kuala Lumpur, Malaysia.
Country 73428 0
Malaysia
Phone 73428 0
+60122880075
Fax 73428 0
Email 73428 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.