Effect of a Bundle of Non-pharmacological Interventions on the Stress Response to Surgery

Pain, Postoperative Clinical Trial

— SPACU-lab  

Official title:

Effect of a Bundle of Non-pharmacological Interventions on the Stress Response to Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05638152
• Other study ID #: N22SCL
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: November 2022
• Source: The Netherlands Cancer Institute
• Contact: Suzanne Broens, PhD
• Phone: 0205122506
• Email: s.broens[@]nki.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

This protocol is a substudy of a larger observational before-after study that studies the effects of the planned implementation of a bundle of non-pharmacological interventions in the post-anesthesia care unit on pain scores, opioid consumption and quality of recovery.

In this current protocol, a subset of 90 surgical patients of a tertiary referral cancer centre in the Netherlands will be included and will be asked to provide informed consent for additional blood samples to be drawn to study the effects of the stress-reducing bundle on biomarkers of the surgical stress response.

45 eligible patients will be approached in the before-arm of the study and 45 will be included for the after-arm. Inclusion criteria are: planned for intermediate to major oncological surgery with an expected duration of >120 minutes, without the use of neuraxial anesthetic techniques. Patients with a planned postoperative ICU-admission will be excluded. After providing informed consent, they will be asked to complete a Quality of Recovery (QoR-15) questionnaire prior to surgery. Additional blood will be drawn with their routine preoperative blood sample on the morning of surgery to determine levels of cortisol, interleukine-6 (IL-6), glucose, C-reactive protein (CRP) and Neutrophil-Lymphocyte Ratio(NLR). The same blood sample will be drawn on arrival in the PACU and on the morning of the first postoperative day. Patients will also be asked to complete the QoR-15 questionnaire again on the first postoperative day.

The primary outcome will be serum cortisol level on the first postoperative day (as a biomarker of the surgical stress response).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Intraoperative Complications
• Pain, Postoperative
• Stress, Physiological
• Stress, Psychological
• Surgical Injury

Intervention

Other:
• implementation of a bundle of non-pharmacological interventions aimed at stress reduction
The bundle consists of 4 interventions: natural imagery in the PACU (wall length decorations and lighted ceiling panels with sky views Aromatherapy with fragrances selected for anxiolytic and antiemetic properties Music available to patients Comfort Talk communication course for PACU nurses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Outcome

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