Pain, Postoperative Clinical Trial
— SPACU-labOfficial title:
Effect of a Bundle of Non-pharmacological Interventions on the Stress Response to Surgery
Rationale: Surgical trauma and post-surgical pain induce a physiological stress response that can be detrimental to the patient. Non-pharmacological interventions aimed at stress reduction are known to reduce pain scores and opioid consumption. The effect of these interventions on the surgical stress response are unknown. Objective: To assess the effect of a bundle of non-pharmacological interventions implemented in the post-anesthesia care unit on the total serum cortisol levels after intermediate and major surgery. Study design: This is a prospective before-after study. Study population: Patients scheduled for intermediate or major oncological surgery in a tertiary referral cancer center. Intervention: The implementation of a bundle of four non-pharmacological interventions aimed at stress reduction in the post-anesthesia care unit. The bundle consists of: access to music, aromatherapy, natural images on the walls and ceiling and communication techniques aimed at reduction of stress and pain. Main study parameters/endpoints: Serum cortisol levels on the first postoperative day.
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | February 1, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - ASA 1-3 - scheduled for intermediate to major oncological surgery - with a minimum duration of 120 mins Exclusion Criteria: - Neuraxial anesthetic technique - planned for postoperative ICU admission - day case surgery - Indication for peri-operative steroids - chronic use of steroids - Bronchial hyperreactivity |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Netherlands Cancer Institute |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | serum cortisol level on POD1 | serum cortisol level on postoperative day 1 | 24 hours | |
Secondary | serum IL-6, glucose, CRP, NLR on POD 1 | serum IL-6, glucose, CRP, NLR on postoperative day 1 | 24 hours |
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