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ID
Source
Brief title
Health condition
Surgical population
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our co-primary endpoints will be the proportion of patients with moderate or severe pain during their PACU stay and the proportion of patients requiring any opioid during their PACU stay.
Secondary outcome
Cumulative opioid dose in the PACU, highest NRS in the PACU, PACU length of stay, patient satisfaction at discharge from the PACU, incidence of PONV in the PACU, incidence of opioid-related adverse events during hospital admission, persistent use of opioids at discharge.
Background summary
Surgical stress, pain and anxiety activate a stress response that can negatively influence post-operative outcomes. This stress response can be influenced by pharmacological and non-pharmacological interventions. Opioids are the cornerstone for the treatment of moderate to severe postoperative pain. However, opioids are associated with adverse respiratory events and opioid addiction. In the U.S, 10% of opioid-naïve patients with cancer undergoing curative-intent surgery develop new persistent opioid use. Non-pharmacological interventions that are aimed at reducing stress have been shown to be cheap, low-risk interventions that affect pain perception and patient outcomes positively.
For this study, a bundle of non-pharmacological interventions will be implemented in the post-anesthesia care unit. The bundle consists of:
a) acces to natural elements in the PACU
b) positive distraction through music
c) aromatherapy
d) introduction of communication techniques that enhance placebo effects and reduce nocebo effects of communication
The effect of the bundle on pain, use of opioids, lenght-of-stay, opioid-related side-effects and adverse events, patient satisfaction and staff satisfaction will be compared to the 6 months prior to implementation of the bundle.
Study objective
The implementation of a bundel of pharamcological interventions aimed at stress reduction leads to lower pain scores and lower use of opioids in the PACU
Study design
Before arm: 6 months data gathering
Implementation of the bundle
After arm: 6 months data gathering
Intervention
1. Acces to nature (full lenght wall coverings and leighted ceiling pannels with nature images)
2. Positive distraction through music
3. Aromatherapy
4. Comfort Talk communication course for nurses
Inclusion criteria
Patients from all surgical disciplines undergoing surgery with a minimum duration of 2 hours and a minimal hospital length of stay of 1 postoperative night will be eligible for inclusion.
Exclusion criteria
Use of neuraxial anesthesia or analgesia, a history of psychiatric illness, chronic pain conditions or chronic use of opioids.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9835 |
| Other | METC AVL : METC 031 |