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Trial registered on ANZCTR


Registration number
ACTRN12618000612213
Ethics application status
Approved
Date submitted
12/04/2018
Date registered
19/04/2018
Date last updated
1/09/2022
Date data sharing statement initially provided
1/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cannabinoids and Acute Post-operative Pain in Participants having Stoma Reversal.
Scientific title
An early phase clinical trial to assess dose-response, feasibility and safety of cannabinoids in patients undergoing ileostomy closure.
Secondary ID [1] 294584 0
JHGIS10
Universal Trial Number (UTN)
Trial acronym
CAPPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain 307372 0
Ilesotomy reversal 307373 0
Condition category
Condition code
Surgery 306478 306478 0 0
Other surgery
Anaesthesiology 306479 306479 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vaporised Bedrobinol Product commenced day 1 post-operatively
Dose level 1 day 1 2.5mg THC flos vaporsied 4 times per day
Dose level 2 day 2 5mg THC flos vaporised 4 times per day if no dose-limiting toxicity greater than grade 2 adverse event
Dose level 3 day 3 10mg THC flos vaporsied 4 times per day if no dose-limiting toxicity greater than grade 2 adverse event.
No further dose after day 3.
Intervention code [1] 300878 0
Treatment: Drugs
Comparator / control treatment
no control group
Control group
Active

Outcomes
Primary outcome [1] 305496 0
Incidence of reduction in dose or stopping therapy
Timepoint [1] 305496 0
post-operative days 1-2
Secondary outcome [1] 345452 0
Plasma concentrations of THC for pharmacokinetic evaluation Cmax, AUC and Tmax
Timepoint [1] 345452 0
Superkush Oil
Days 1-3 post-op measured at time of adminsitration then 15, 30, 60 and 90 minutes post dose, once per day
Secondary outcome [2] 345453 0
Plasma concentrations of THC for pharmacokinetic evaluation Cmax, AUC and Tmax
Timepoint [2] 345453 0
Bedrocan vaporised cannabis flos
Days 1-3 post-op measured at at time of administration 5, 10, 30 and 60 minutes post-dose once per day
Secondary outcome [3] 345454 0
Plasma concentrations of THC for pharmacokinetic evaluation Cmax, AUC and Tmax
Timepoint [3] 345454 0
Sativex oromucosal spray
Days 1-3 post-op measured at time of administration then 30, 60 and 90 minutes psot-dose once per day.
Secondary outcome [4] 345455 0
Time to flatus in hours from the medical record as recorded by nursing or medical staff.
Timepoint [4] 345455 0
In hours from end of operation to discharge
Secondary outcome [5] 345457 0
Length of hospital stay as assessed from medical record admission and discharge dates.
Timepoint [5] 345457 0
At discharge
Secondary outcome [6] 345459 0
Time to gastric emptying assessed by gastric ultrasound at 10 minutely intervals for
1 hour or until complete gastric emptying after ingestion orally of 250mls of water.
Timepoint [6] 345459 0
Performed three times daily for 3 days post-op after 2nd dose of study drug.
Secondary outcome [7] 345460 0
Incidence of post-op nausea and vomiting as measured by the Simplified Post-op nausea and vomiting scale
Timepoint [7] 345460 0
Daily for 3 days post-operatively
Secondary outcome [8] 345461 0
Mean post-operative analgesic consumption (MilliEquivalents of morphine) calculated by review of medication administration records signed by administering nursing staff,
Timepoint [8] 345461 0
Daily for hospital admission and total.
Secondary outcome [9] 345462 0
Mean daily mobility score using the de Morton Mobility Index (DEMMI) score
Timepoint [9] 345462 0
At baseline and post-operatively until discharge asssessed by research staff.
Secondary outcome [10] 345463 0
Incidence Surgical complications graded by the Clavien-Dindo Classification of Surgical Complications
Timepoint [10] 345463 0
Post-operatively to day 30
Secondary outcome [11] 345627 0
Plasma concentrations of CBD for pharmacokinetic evaluation Cmax, AUC and Tmax
Timepoint [11] 345627 0
Superkush Oil
Days 1-3 post-op measured at time of adminsitration then 15, 30, 60 and 90 minutes post dose, once per day
Secondary outcome [12] 345628 0
Plasma concentrations of CBD for pharmacokinetic evaluation Cmax, AUC and Tmax
Timepoint [12] 345628 0
Bedrocan vaporised cannabis flos
Days 1-3 post-op measured at at time of administration 5, 10, 30 and 60 minutes post-dose once per day.
Secondary outcome [13] 345629 0
Plasma concentrations of CBD for pharmacokinetic evaluation Cmax, AUC and Tmax
Timepoint [13] 345629 0
Bedrocan vaporised cannabis flos
Days 1-3 post-op measured at at time of administration 5, 10, 30 and 60 minutes post-dose once per day.

Eligibility
Key inclusion criteria
- Aged 18 years or older
- Signed written informed consent
- Undergoing reversal of ileostomy at participating hospital
- Willing and able to comply with all study requirements, including treatment, timing and assessments including blood tests, and,
- Undertaking by participant both male and female of child bearing potential to take reliable contraceptive precautions for the duration of therapy and for three months after discontinuation of therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients from the above group will be excluded if they:
- Are pregnant, lactating, or using inadequate contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to study participation. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.
- Have severe renal impairment
- Unstable cardiovascular disease (uncontrolled hypertension, unstable ischaemic heart disease,
- History of epilepsy or recurrent seizures
- History of schizophrenia, other psychotic illness, severe personality disorder, suicidal ideation, or other significant psychiatric disorder, other than depression associated with underlying condition
- Substance use disorder to alcohol, opioids, benzodiazepines, or illicit stimulants
- Concomitant treatment with any potent CYP3A4 inhibitors such as ketoconazole, macrolides
- Is scheduled to receive any other investigational drug during the present study
- Prior hypersensitivity or intolerable adverse reaction to cannabis or cannabinoid based medications, 5HT3 antagonist, dexamethasone, NK1 antagonist
- have a known allergy or adverse drug reaction to cannabinoids and its excipients
- remain intubated post-procedure

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Pandemic
Date of first participant enrolment
Anticipated
29/04/2019
Actual
11/06/2019
Date of last participant enrolment
Anticipated
Actual
30/06/2020
Date of last data collection
Anticipated
Actual
30/07/2020
Sample size
Target
18
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10646 0
John Hunter Hospital - New Lambton

Funding & Sponsors
Funding source category [1] 299200 0
Hospital
Name [1] 299200 0
John Hunter Hospital
Country [1] 299200 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Lokced Bag 1
Hunter Region Mail Centre NSW 2310
Country
Australia
Secondary sponsor category [1] 298463 0
None
Name [1] 298463 0
Address [1] 298463 0
Country [1] 298463 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300125 0
Huner New England Hman Research Ethics Committee
Ethics committee address [1] 300125 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 300125 0
Australia
Date submitted for ethics approval [1] 300125 0
31/08/2017
Approval date [1] 300125 0
11/12/2017
Ethics approval number [1] 300125 0
17/09/20/3.01

Summary
Brief summary
This is a research study examining whether medicinal cannabis can safely be given to people who are having a surgical procedure involving the bowel.
When a person undergoes major surgery on the abdomen, care after the surgery involves the administration of medications that help relieve pain associated with the surgical procedure. Some of these drugs are called “opioids”. Most patients in this study will probably have had these drugs for the previous surgery in the form of morphine or “morphine-like” drugs given via the intravenous drip or a tablet taken by mouth. The side effects of these drugs include:
• Slowing of bowel function
• Sleepiness
• Slowed breathing
• Nausea and vomiting
• Decreased appetite
This study is not designed to test if medical cannabis is an effective pain management option, but rather seeks to assess if the drug can be safely administered and can be tolerated by patients having surgery such as your procedure and measure blood levels of cannabis chemicals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61922 0
A/Prof Stephen Smith
Address 61922 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 61922 0
Australia
Phone 61922 0
+61 2 49855153
Fax 61922 0
Email 61922 0
HNELHD-SurgeryResearch@health.nsw.gov.au
Contact person for public queries
Name 61923 0
Ms Rosemary Carroll
Address 61923 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 61923 0
Australia
Phone 61923 0
+61 2 49855153
Fax 61923 0
Email 61923 0
HNELHD-SurgeryResearch@health.nsw.gov.au
Contact person for scientific queries
Name 61924 0
A/Prof Stephen Smith
Address 61924 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 61924 0
Australia
Phone 61924 0
+61 2 49855153
Fax 61924 0
Email 61924 0
HNELHD-SurgeryResearch@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.