Multimodal Pain Treatment for Breast Cancer Surgery - a Prospective Cohort Study
NCT ID: NCT04875559
Last Updated: 2023-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
236 participants
OBSERVATIONAL
2021-04-19
2022-08-18
Brief Summary
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Detailed Description
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Furthermore, patients will be informed that participation is voluntary and that a wish for withdrawal will be granted immediately.
The informed consent will grant the investigators direct access to data in the patients' electronic files to ensure the information necessary for the study. The patients also consent to complete the questionnaires in the seven-day follow-up period, and that the investigators can reach them by phone.
Completion of the study It is considered a completion of the study when a patient has signed the informed consent, has followed the treatment regimen, and answered the questionnaires in the seven-day follow-up period.
If a patient does not complete the study, an account should be given as to whether and how this subject's data is handled in the study - this also replies to drop-outs.
Reasons for withdrawal
\- If a patient wishes to withdraw from the study In accordance with the Declaration of Helsinki, patients have the right to withdraw from the study at any time for any reason. The investigators also have the right to withdraw a patient from the study at any time. The reason for withdrawal must be recorded.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Breast cancer surgery patients.
Patients scheduled for day-case unilateral breast conserving surgery or mastectomy with or without axillary lymph node dissection or sentinel lymph node biopsy. No intervention.
Standardised multimodal pain treatment regimen
Preoperatively:
* Paracetamol 1000 mg p.o.
* Celecoxib 400 mg p.o.
* Dexamethasone 12 mg p.o.
Perioperatively:
* Ondansetron 4 mg IV
* Bupivacaine 2.5 mg/mL, 20 mL LIA
* Oxycodone 0.15 mg/kg IV (Oxycodone 0.25 mg/kg for ALND)
Postoperatively:
* Paracetamol 1000 mg p.o. every 6h PRN
* Ibuprofen 400 mg p.o. every 6h (day 1-5) PRN
* Oxycodone 5 mg IV or 10 mg p.o. PRN
* Ondansetron 4 mg IV or p.o. PRN
Interventions
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Standardised multimodal pain treatment regimen
Preoperatively:
* Paracetamol 1000 mg p.o.
* Celecoxib 400 mg p.o.
* Dexamethasone 12 mg p.o.
Perioperatively:
* Ondansetron 4 mg IV
* Bupivacaine 2.5 mg/mL, 20 mL LIA
* Oxycodone 0.15 mg/kg IV (Oxycodone 0.25 mg/kg for ALND)
Postoperatively:
* Paracetamol 1000 mg p.o. every 6h PRN
* Ibuprofen 400 mg p.o. every 6h (day 1-5) PRN
* Oxycodone 5 mg IV or 10 mg p.o. PRN
* Ondansetron 4 mg IV or p.o. PRN
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years of age.
* Patients who received written and oral information, and have signed the informed consent form on participation in the study.
* Patients living in the Region of Zealand.
Exclusion Criteria
* Inability to cooperate and to consent.
18 Years
FEMALE
No
Sponsors
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Zealand University Hospital
OTHER
Responsible Party
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Principal Investigators
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Anne Sofie N Therkelsen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anaesthesiology, Zealand University Hospital, Roskilde, Denmark
Locations
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Zealand University Hospital, Department of Anaesthesiology
Roskilde, , Denmark
Countries
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References
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Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
Moo TA, Sanford R, Dang C, Morrow M. Overview of Breast Cancer Therapy. PET Clin. 2018 Jul;13(3):339-354. doi: 10.1016/j.cpet.2018.02.006.
Habib AS, Kertai MD, Cooter M, Greenup RA, Hwang S. Risk factors for severe acute pain and persistent pain after surgery for breast cancer: a prospective observational study. Reg Anesth Pain Med. 2019 Feb;44(2):192-199. doi: 10.1136/rapm-2018-000040. Epub 2019 Jan 5.
Lepot A, Elia N, Tramer MR, Rehberg B. Preventing pain after breast surgery: A systematic review with meta-analyses and trial-sequential analyses. Eur J Pain. 2021 Jan;25(1):5-22. doi: 10.1002/ejp.1648. Epub 2020 Oct 4.
Gartner R, Kroman N, Callesen T, Kehlet H. Multimodal prevention of pain, nausea and vomiting after breast cancer surgery. Minerva Anestesiol. 2010 Oct;76(10):805-13.
Gong Y, Tan Q, Qin Q, Wei C. Prevalence of postmastectomy pain syndrome and associated risk factors: A large single-institution cohort study. Medicine (Baltimore). 2020 May;99(20):e19834. doi: 10.1097/MD.0000000000019834.
Sagen A, Karesen R, Sandvik L, Risberg MA. Changes in arm morbidities and health-related quality of life after breast cancer surgery - a five-year follow-up study. Acta Oncol. 2009;48(8):1111-8. doi: 10.3109/02841860903061691.
Jacobs A, Lemoine A, Joshi GP, Van de Velde M, Bonnet F; PROSPECT Working Group collaborators#. PROSPECT guideline for oncological breast surgery: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2020 May;75(5):664-673. doi: 10.1111/anae.14964. Epub 2020 Jan 26.
Steinthorsdottir KJ, Awada HN, Abildstrom H, Kroman N, Kehlet H, Aasvang EK. Dexamethasone Dose and Early Postoperative Recovery after Mastectomy: A Double-blind, Randomized Trial. Anesthesiology. 2020 Apr;132(4):678-691. doi: 10.1097/ALN.0000000000003112.
Petersen M, Joost M, Therkelsen AS, Geisler A. Women's Experiences of Sequelae After Mastectomy: A 3, 6, and 12 Months' Follow-up Study. Cancer Nurs. 2025 Sep-Oct 01;48(5):401-408. doi: 10.1097/NCC.0000000000001341. Epub 2024 Mar 7.
Other Identifiers
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REG-028-2021
Identifier Type: -
Identifier Source: org_study_id
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