Breast Cancer Clinical Trial
Official title:
Influence of Nociception Level Monitor (NOL) During Guided Analgesic Delivery in Breast Surgeries on the Perioperative Course, Quality of Recovery and Hospital Stay
Verified date | September 2023 |
Source | University of Southern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess if perioperative consumption of opioids can be optimized with the assistance of a Nociception Level (NOL) monitor in breast surgery patients receiving pectoral and parasternal nerve blocks as supplementation to general anaesthesia. Hypothesis: 1. NOL monitor guidance optimizes perioperative analgesic consumption and postoperative length of stay and offers a better quality of recovery in breast surgery. 2. Intraoperative NOL monitoring can detect the efficacy of pectoralis and parasternal nerve blocks. 3. Incidence of persistent neuropathic pain after breast cancer surgery is lower in patients receiving lower doses of perioperative opioids.
Status | Enrolling by invitation |
Enrollment | 60 |
Est. completion date | March 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - American Society of Anaesthesiologists (ASA) class I-IV patients scheduled for an elective mastectomy with or without axillary resection Exclusion Criteria: - Inability to give consent, - atrial fibrillation, - local anesthetic allergy, - lumpectomy converted to Mastectomy. |
Country | Name | City | State |
---|---|---|---|
Denmark | Sygehus Soenderjylland | Aabenraa |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark |
Denmark,
Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130. — View Citation
Martini CH, Boon M, Broens SJ, Hekkelman EF, Oudhoff LA, Buddeke AW, Dahan A. Ability of the nociception level, a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia. Anesthesiology. 2015 Sep;123(3):524-34. doi: 10.1097/ALN.0000000000000757. — View Citation
Stockle PA, Julien M, Issa R, Decary E, Brulotte V, Drolet P, Henri M, Poirier M, Latulippe JF, Dorais M, Verdonck O, Fortier LP, Richebe P. Validation of the PMD100 and its NOL Index to detect nociception at different infusion regimen of remifentanil in patients under general anesthesia. Minerva Anestesiol. 2018 Oct;84(10):1160-1168. doi: 10.23736/S0375-9393.18.12720-9. Epub 2018 May 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peroperative Remifentanil consumption | ( peroperative, mg) | during the surgery | |
Primary | Peroperative Morphine consumption | (peroperative, mg) | during the surgery | |
Secondary | Postoperative Maximum pain score | measured using numerical rating scale (NRS) (0-10). The score can vary between 0 and 10 by which 0 means no pain and 10 equals the worst possible pain. | immediately after the surgery | |
Secondary | Post-operative opioid consumption | Morphine, mg | immediately after the surgery | |
Secondary | Eligible time to discharge | Time in the post anaesthesia care unit based on a post anaesthesia care score scheme derived from objective vital parameters (Minutes) | immediately after the surgery | |
Secondary | Length of hospital stay | Hours | From admission to discharge, up to 72 hours | |
Secondary | Incidence of post-operative nausea and vomiting | Number of patients with post-operative nausea and vomiting | immediately after the surgery | |
Secondary | Requirement for additional antiemetic drugs | Number 1-3 | immediately after the surgery | |
Secondary | Persistent neuropathic pain after breast cancer surgery | Number of patients experiencing pain due to breast cancer surgery measured using numerical rating scale (NRS) (0-10). The score can vary between 0 and 10 by which 0 means no pain and 10 equals the worst possible pain. | up to 3 months after surgery | |
Secondary | Length of time in recovery room | minutes | immediately after surgery |
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