Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001142325p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
27/08/2026
Date registered
Help: Date registered
15/09/2026
Date last updated
Help: Date last updated
15/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
15/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
An analgesic-based education intervention to support orthopaedic surgery patients to manage their post-discharge pain: a feasibility pilot study
Scientific title
Closing the analgesic education gap to support orthopaedic surgery patients to manage their post-discharge pain: a pilot study of an education intervention informed by patient priorities and clinician consensus
Additional trial identifiers [1] 318191 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Postoperative pain 343249 0
Condition category
Condition code
Surgery 339359 339359 0 0
Other surgery
Anaesthesiology 339620 339620 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This study will trial an analgesic education intervention designed to empower adult patients undergoing open orthopaedic surgery to optimally self-manage their postoperative pain at home, with a particular focus on the appropriate use of analgesic medications.

The intervention will be delivered in two phases: an initial face-to-face session prior to hospital discharge, followed by a series of telephone support calls after the patient returns home.

Pre-discharge session: On the day of (or the day prior to) hospital discharge, a clinical pharmacist will conduct a brief 10-to-20-minute face-to-face education session with each participant at the bedside. Education will cover key topics including: general postoperative pain expectations; the patient's prescribed analgesics and how to take them in combination for optimal multimodal pain relief; common side effects and strategies to minimise their risk; and guidance on safely weaning analgesics as pain improves. To reinforce this verbal education, participants will also receive a supplementary written information sheet. This written information sheet has been developed specifically for use in this study.

Post-discharge telephone follow-up: To support the transition home, the same clinical pharmacist will contact participants via telephone up to three times within the first 10 days following discharge, at approximately 24–48 hours, 5–6 days, and 9–10 days after returning home. Each call is expected to last between 5 and 15 minutes and will provide an opportunity to follow up on the patient's recovery, address any concerns, and offer further information regarding pain and analgesic management.

Adherence and feasibility: Adherence to the intervention will be monitored by tracking the proportion of participants who complete both the in-person session and follow-up telephone calls. Finally, 14 days post-discharge, participants will be contacted to complete a post-intervention questionnaire, which will assess the acceptability of the education program from the patient's perspective.
Intervention code [1] 335097 0
Treatment: Other
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346572 0
To assess the feasibility of delivering the analgesic education intervention as planned to patients following orthopaedic surgery.
Timepoint [1] 346572 0
10 days following hospital discharge
Secondary outcome [1] 466433 0
- Cumulative time taken (in minutes) to deliver all education sessions to participants
Timepoint [1] 466433 0
Cumulative time will be calculated once all education sessions for a patient have been completed.
Secondary outcome [2] 466863 0
- Patient-reported satisfaction with the intervention
Timepoint [2] 466863 0
14 days following hospital discharge
Secondary outcome [3] 466864 0
- Patient-reported confidence to select the most appropriate analgesic to manage pain at home
Timepoint [3] 466864 0
14 days following hospital discharge
Secondary outcome [4] 466865 0
- Patient-reported knowledge regarding how to take analgesics (including in combination)
Timepoint [4] 466865 0
14 days following hospital discharge
Secondary outcome [5] 466866 0
Patient-perceived empowerment to manage pain with analgesics at home
Timepoint [5] 466866 0
14 days following hospital discharge
Secondary outcome [6] 467533 0
Patient-reported understandability
Timepoint [6] 467533 0
14 days following hospital discharge
Secondary outcome [7] 467534 0
Patient-reported ability to hear education
Timepoint [7] 467534 0
14 days following hospital discharge
Secondary outcome [8] 467535 0
Patient-reported confidence to wean analgesics as pain improved
Timepoint [8] 467535 0
14 days following hospital discharge
Secondary outcome [9] 467536 0
Patient-reported knowledge regarding analgesic side effects
Timepoint [9] 467536 0
14 days following hospital discharge
Secondary outcome [10] 467537 0
Patient-reported knowledge of potential risks with analgesics
Timepoint [10] 467537 0
14 days following hospital discharge

Eligibility
Key inclusion criteria
Any person, aged 18 years or older, undergoing an open orthopaedic procedure at Tauranga hospital or Grace hospital (Tauranga, Bay of Plenty), that requires at least one night stay in hospital will be eligible for this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
- Undergo an arthroscopic, or other minimally invasive procedure, or are discharged on the same day as surgery
- Are undergoing amputation or oncological-related surgery
- Undergoing a subsequent surgery for the same issue (e.g., second stage joint revision surgery) if the primary surgery was within six months prior.
- Require a prolonged hospital admission due to postoperative complications, such as infection or thrombosis, or transfer to the in-hospital rehabilitation ward for their recovery
- Require transfer to a community (out-of-hospital) rehabilitation centre for their recovery or to permanently move to an aged-care centre.
- Require minimal pain relief (single agent non-opioid analgesia only) following their procedure.
- Are pregnant or breastfeeding.
- Cannot communicate in English and/or cannot be contacted via telephone (or video call).
- Have documented cognitive impairment or are otherwise unable to provide informed consent or actively participate in the intervention.
- Do not normally manage their medications at home (not including receiving assistance from whanau (family).
- Are under a pharmacotherapy treatment program for substance use disorders, including opioids, alcohol, and other substances.
- Undergoing orthopaedic surgery funded privately (not by the public health service).

Study design
Purpose of the study
Educational / counselling / training
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This will be a pilot study that does not include a control group. All study participants will receive the same education intervention.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/09/2026
Actual
Date of last participant enrolment
Anticipated
23/12/2026
Actual
Date of last data collection
Anticipated
6/01/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 28439 0
New Zealand
State/province [1] 28439 0

Funding & Sponsors
Funding source category [1] 322757 0
University
Name [1] 322757 0
University of Tasmania
Country [1] 322757 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Country
Australia
Secondary sponsor category [1] 325678 0
None
Name [1] 325678 0
Address [1] 325678 0
Country [1] 325678 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 321194 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 321194 0
Ethics committee country [1] 321194 0
New Zealand
Date submitted for ethics approval [1] 321194 0
27/08/2026
Approval date [1] 321194 0
Ethics approval number [1] 321194 0
Ethics committee name [2] 321203 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [2] 321203 0
Ethics committee country [2] 321203 0
Australia
Date submitted for ethics approval [2] 321203 0
27/08/2026
Approval date [2] 321203 0
Ethics approval number [2] 321203 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 152974 0
Dr Felicity Veal
Address 152974 0
School of Pharmacy and Pharmacology, University of Tasmania, Churchill Ave, Sandy Bay, Hobart, 7005 Tasmania
Country 152974 0
Australia
Phone 152974 0
+61362262312
Fax 152974 0
Email 152974 0
[email protected]
Contact person for public queries
Name 152975 0
Dr Felicity Veal
Address 152975 0
School of Pharmacy and Pharmacology, University of Tasmania, Churchill Ave, Sandy Bay, Hobart, 7005 Tasmania
Country 152975 0
Australia
Phone 152975 0
+61362262312
Fax 152975 0
Email 152975 0
[email protected]
Contact person for scientific queries
Name 152976 0
Dr Felicity Veal
Address 152976 0
School of Pharmacy and Pharmacology, University of Tasmania, Churchill Ave, Sandy Bay, Hobart, 7005 Tasmania
Country 152976 0
Australia
Phone 152976 0
+61362262312
Fax 152976 0
Email 152976 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.