Cannabinoids and Acute Post-operative Pain in Participants having Stoma Reversal.

Phase 1

• Conditions: Post-operative pain; Ilesotomy reversal; Surgery - Other surgery; Anaesthesiology - Pain management

• Registration Number: ACTRN12618000612213
• Lead Sponsor: Hunter New England Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-19
• Study Completion: 2020-07-30
• Last Update Posted: 5 September 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 6

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of reduction in dose or stopping therapy [post-operative days 1-2]