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Trial registered on ANZCTR


Registration number
ACTRN12618000793213p
Ethics application status
Submitted, not yet approved
Date submitted
26/02/2018
Date registered
10/05/2018
Date last updated
3/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Subcutaneous Sumatriptan for Treatment of Post-Operative Neurosurgical Pain
Scientific title
Subcutaneous Sumatriptan Use for Treatment of Post-Craniotomy Pain- Randomised Double Blinded Placebo controlled Trial
Secondary ID [1] 294162 0
Nil known
Universal Trial Number (UTN)
U1111-1209-9072
Trial acronym
SUPS Trial
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Post-Craniotomy Pain Management 306792 0
Condition category
Condition code
Anaesthesiology 305893 305893 0 0
Pain management
Anaesthesiology 305894 305894 0 0
Anaesthetics
Neurological 305895 305895 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patient will be randomised to one of two groups: an active treatment or placebo control group.
Intervention: After completion of the Craniotomy for a surgical condition, the patients in the active treatment group will be administered subcutaneous single dose of 6 mg sumatriptan for active management of post-operative pain. The site of administration will be chosen by the recovery nurse based on individual factors e.g. arm, abdomen, or leg. Following this pain will be re-assessed at five minute intervals and the usual post-operative prescribed opioid regime will be administered. The usual immediate prescribed post-operative regime involves administration of the intravenous recovery protocol to be used in the recovery area. The medication chosen can be e.g. oxycodone, fentanyl or morphine at the discretion of the treating anaesthetist. If the patient is randomised, but medication is not administered, this will be recorded and data analysed on an intention to treat basis. Adherence with protocol compliance will be monitored through regular monthly study audits.
Intervention code [1] 300452 0
Treatment: Drugs
Comparator / control treatment
The Placebo Control Group: After Completion of the Craniotomy for a surgical condition, patients randomised to the placebo group will be administered subcutaneous normal saline, in the equivalent volume to the treatment drug volume . Post-Operative pain will be re-assessed at five minute intervals, and the usual prescribed opioid regime will be administered. Adherence with protocol compliance will be monitored.
Control group
Placebo

Outcomes
Primary outcome [1] 304937 0
Post-Craniotomy Pain as measured using Visual Analogue Score.
Timepoint [1] 304937 0
Visual Analogue Score 30 mins post subcutaneous administration of Sumatriptan or placebo.
Secondary outcome [1] 343654 0
Visual Analogue Score 60 minutes post subcutaneous administration of Sumatriptan or placebo.
Timepoint [1] 343654 0
one time only as measured 60 minutes post trial drug administration.
Secondary outcome [2] 343655 0
Pain level as measured Visual Analogue Scores.
Timepoint [2] 343655 0
As measured 24 hours post-operatively.
Secondary outcome [3] 343656 0
Quality of Recovery Scores. Validated multi- question Quality of Recovery Score who includes questions about general well-being, support, ease of breathing, nausea, vomiting and pain.
Timepoint [3] 343656 0
24 hours post-operatively.
Secondary outcome [4] 343657 0
Evaluate total hospital length of stay for each patient- by following up the patient at a weekly time point after surgery and recording the length of stay.
Timepoint [4] 343657 0
At the end of the hospital stay for each patient.
Secondary outcome [5] 343764 0
Total opioid consumption and other analgesic use- as assessed by reviewing the dosage administered in the medication charts and measuring in the additive fashion.
Timepoint [5] 343764 0
At 24 hours post-operatively.

Eligibility
Key inclusion criteria
All adult patients over 18 undergoing Craniotomy
Fully autonomous and able to give a valid consent for surgery and this particular study, or have mild underlying cognitive impairment only with the consent being given by the next of kin.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not autonomous and unwilling to give a valid consent for surgery and this particular study, or have mild underlying cognitive impairment only, with the consent being withheld by the next of kin
Craniotomy for cerebrovascular surgery (i.e. cerebral aneurysm or arteriovenous malformation)
Previous Ischemic or Haemorrhagic CVA
Unstable Angina or Previous AMI
Severe Hepatic Impairment
Uncontrolled Hypertension
Previous Sensitivity to Sumatriptan
Current Treatment with MAOI's
Current Treatment with SSSRI's
Emergency Re-Operative Craniotomy

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)
Randomisation will be performed in the hospital centrally by the Pharmacy Department. The principal investigators, patients or the nursing staff involved in patient care will not be involved in the process of randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence will be generated centrally by the hospital Pharmacy Department through permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
This is a single centre, double-blinded, randomised, 18 months duration parallel group trial to compare the efficacy of subcutaneous sumatriptan with placebo followed by standard pain protocols.
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Statistical methods / analysis
The Intervention arm will be compared against the control for all primary analysis. Descriptive statistics mean (SD) or median (IQR) will be used for continuous variables. Normality of data will be confirmed through graphic histogram plots and specific data tests.
We plan to use the student's T-test to compare the means of different groups for the continuous outcomes of pain scores. Quantitative variables will be compared using the Student's t-test or Mann Whitney U-test to compare the independent means. When indicated, a one-way repeated measures ANOVA will be performed. Categorical variables will be presented as absolute frequencies and percentage. The two groups will be compared using the X² or Fisher exact test. We plan to conduct the two subgroup analysis-based on the anatomical site of surgery as well as the urgency of surgery.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10225 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 21756 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 298798 0
Hospital
Name [1] 298798 0
Anaesthesia Department Austin Health
Address [1] 298798 0
145 Studley Road, Heidelberg , Victoria 3084, Australia
Country [1] 298798 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
145 Studley Road, Heidelberg , Victoria 3084, Australia
Country
Australia
Secondary sponsor category [1] 297987 0
None
Name [1] 297987 0
Address [1] 297987 0
Country [1] 297987 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299744 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 299744 0
145 Studley Road, Heidelberg, Victoria 3084, Australia
Ethics committee country [1] 299744 0
Australia
Date submitted for ethics approval [1] 299744 0
29/11/2017
Approval date [1] 299744 0
Ethics approval number [1] 299744 0

Summary
Brief summary
Craniotomy is one of the common surgeries performed in the modern day and age with brain tumour being the seventh commonest diagnosed cancer in the world. There are multiple other surgical conditions being amenable to craniotomy: Resection of brain tumours and arteriovenous malformations, clipping of brain aneurysms and microvascular decompression for trigeminal neuralgia just to mention a few.

Post-craniotomy pain is often under-treated and under-estimated. Both acute and chronic post craniotomy headaches have been found to be common and significant clinical phenomena. In cross-sectional studies of the immediate post-operative pain levels, post craniotomy pain incidence is at 60 percent, more common than generally assumed.
Post-operative pain is a common factor in delayed mobilization, lengthened hospital stay, development of anxiety and depression as well as development of chronic pain.
Opioids are still the mainstay of post-operative craniotomy pain management. However effective opioid analgesia administration for the purposes of pain relief can precipitate decreased respiration and hypercarbia.

We plan to recruit a total of 136 patients in this parallel arm double- blind trial in order to test our hypothesis that patients receiving subcutaneous sumatriptan will have improved analgesia control and recovery scores post-operatively. We will follow up the patients at 30 days to assess these outcomes at the thirty day mark.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81434 0
Dr Jeremy Russell
Address 81434 0
145 Studley Road, Austin Health, Heidelberg, Victoria 3084
Country 81434 0
Australia
Phone 81434 0
+61 3 94965000
Fax 81434 0
Email 81434 0
jeremy.russell@austin.org.au
Contact person for public queries
Name 81435 0
Dr Ana Licina
Address 81435 0
145 Studley Road, Austin Health, Heidelberg, Victoria 3084
Country 81435 0
Australia
Phone 81435 0
+61 3 94965000
Fax 81435 0
Email 81435 0
ana.licina@austin.org.au
Contact person for scientific queries
Name 81436 0
Dr Dean Cowie
Address 81436 0
145 Studley Road, Austin Health, Heidelberg, Victoria 3084
Country 81436 0
Australia
Phone 81436 0
+61 3 94965000
Fax 81436 0
Email 81436 0
dean.cowie@austin.org.au

No information has been provided regarding IPD availability
Summary results
No Results