None listed
Conditions
Brief summary
Effective postoperative pain management is essential for patient recovery, satisfaction, and prevention of complications. Opioid analgesics are routinely used for the management of acute pain following surgery, and pain in practice often has been assessed using unidimensional scales such as the Numeric Rating Scale. The Australian Commission on Safety and Quality in Healthcare has released a Clinical Care Standard for opioid analgesic stewardship in acute pain recommending that clinicians assess a patient’s functional activity using an evidence-based tool before prescribing opioid analgesics, with the Functional Activity Score (FAS) provided as an example. The FAS offers a multidimensional approach by assessing how pain interferes with activity. Despite these recommendations to include functional assessments, evidence supporting the FAS in Australian hospital settings remains limited. Thus, there is a clear need to address this gap by providing data on the utility and impact of the FAS in an Australian hospital population. This trial addresses that gap by assessing whether integrating the FAS into postoperative care reduces opioid use and improves pain related outcomes.
Interventions
This randomised controlled trial aims to evaluate whether incorporating a multidimensional pain assessment tool (Functional Activity Score, FAS), alongside a standard unidimensional assessment (Numeric Rating Scale, NRS) will result in reduced opioid consumption during hospitalisation.
The intervention arm involves the addition of the FAS assessment concurrently with the NRS, alongside routine postoperative care. This intervention will take place on the ward after patients have been transferre
This randomised controlled trial aims to evaluate whether incorporating a multidimensional pain assessment tool (Functional Activity Score, FAS), alongside a standard unidimensional assessment (Numeric Rating Scale, NRS) will result in reduced opioid consumption during hospitalisation. The intervention arm involves the addition of the FAS assessment concurrently with the NRS, alongside routine postoperative care. This intervention will take place on the ward after patients have been transferred from the Intensive Care Unit following their surgery. Intervention patients will receive standard multimodal analgesia. Nurses will perform a combined NRS and FAS assessment at each routine postoperative pain observation (every 6 hours while awake, in line with usual care) from ward admission until postoperative day 14 or hospital discharge, whichever occurs first. The FAS will be documented together with the corresponding NRS score in the observation chart and electronic medical record. All nursing staff on the intervention will receive structured education on the FAS and its application. Education will be delivered by the research team and acute pain service clinicians (for example, pain nurse consultant and pain specialist) as a 1-2 hour face-to-face small-group session, scheduled approximately 2-4 weeks prior to enrolment of the first participant on each ward, with additional brief refresher sessions or ad hoc training for new or casual staff during the recruitment period. Adherence to the intervention will be monitored through regular audit of medical records and observation charts with feedback provided to nurse unit managers to address any barriers identified (for example, time constraints, understanding of the tool).
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adults aged 18 years or older • Capable of providing informed consent • Able to self-report pain and understand numeric/alphabetic scales (e.g. NRS, FAS) • Undergoing head and neck free flap reconstruction surgery • Hospitalised postoperatively for at least 24 hours with access to prescribed analgesia • Opioid naïve: no use of any opioid analgesic within the last 30 days before surgery, as verified by both checking a prescription drug monitoring program like Safescript, and a patient self-report. • Surgical procedure anticipated to cause at least moderate acute postoperative pain, with expected Clavien-Dindo classification of grade I or II for complications (i.e. minor complications not requiring major intervention)
Exclusion criteria
• Patients on chronic opioid therapy or opioid substitution therapy • Patients with chronic pain (Defined as pain lasting =3 months and requiring regular analgesic (including opioid) therapy, or with a formal diagnosis of chronic pain disorder prior to surgery) • Cognitive impairment, language barrier, or history of a psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study • Palliative care patients • Emergency surgeries or cases where perioperative opioid prescribing cannot be standardised • Allergy or contraindication to opioids
Outcome results
None listed