Clinical Trials Logo

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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05638152
Study type Observational
Source The Netherlands Cancer Institute
Contact Suzanne Broens, PhD
Phone 0205122506
Email s.broens@nki.nl
Status Not yet recruiting
Phase
Start date May 1, 2023
Completion date February 1, 2024

See also
  Status Clinical Trial Phase
Completed NCT05480111 - The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy Phase 4
Completed NCT06129305 - Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
Completed NCT04401826 - Micro-surgical Treatment of Gummy Smile N/A
Recruiting NCT04020133 - the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction. N/A
Completed NCT03023462 - Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair N/A
Completed NCT03546738 - Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery N/A
Completed NCT03652103 - Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy Phase 4
Withdrawn NCT03528343 - Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy Phase 1/Phase 2
Terminated NCT03261193 - ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain Phase 3
Completed NCT02525133 - Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty Phase 3
Completed NCT03244540 - Regional Analgesia After Cesarean Section Phase 4
Enrolling by invitation NCT05316168 - Post Operative Pain Management for ACL Reconstruction Phase 3
Recruiting NCT04130464 - Intraperitoneal Infusion of Analgesic for Postoperative Pain Management Phase 4
Enrolling by invitation NCT04574791 - Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty N/A
Completed NCT04073069 - Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults Phase 4
Completed NCT04526236 - Influence of Aging on Perioperative Methadone Dosing Phase 4
Recruiting NCT05351229 - Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery Phase 4
Enrolling by invitation NCT05543109 - Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block N/A
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Completed NCT04919317 - Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty Phase 2