Clinical trial NCT04875559: Multimodal Pain Treatment for Breast Cancer Surgery - a Prospective Cohort Study
Official title: Multimodal Pain Treatment for Breast Cancer Surgery - a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Female
Postoperative Pain
Postoperative Nausea and Vomiting
Keywords: Multimodal pain management
Opioid-sparing pain management
Quality of recovery
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 236
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients scheduled for breast conserving surgery or mastectomy with or without ALND or SLNB at Zealand University Hospital, Roskilde, will be invited to participate in the study.

Brief summary: Breast cancer is one of the most common types of cancer among women worldwide. (1) Breast-conserving surgery or mastectomy is indicated for the majority of patients with this type of cancer. (2) Postoperative pain is frequent in this population, with almost 50 % experiencing acute pain and 25-60 % subsequently live with chronic pain. (3-5) Today no golden standard for postoperative pain management regarding breast cancer surgeries exists, and there is definitely room for improvement. Especially considering the large population of women with breast cancer and consequences of acute and chronic pain, such as prolonged recovery and affected quality of life. (6,7) With the present study, we aim to optimise postoperative pain treatment and investigate the effect of a standardised multimodal postoperative analgesic regimen based on previous recommendations. (4,8,9)

Detailed description: All patients scheduled for breast conserving surgery or mastectomy with or without ALND or SLNB at Zealand University Hospital, Roskilde, will be invited to participate in the study. When the patients arrive for preoperative preparation on the day of surgery, one of the investigators will be responsible for a thorough oral information regarding the purpose of the study and all relevant participation requirements. The conversation will take place in a closed room, and the informed consent form will be obtained if the patient decides to participate.

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.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for day-case unilateral breast conserving surgery or mastectomy +/- ALND or SLNB.
* 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:

* Not able to speak, read, or understand Danish.
* Inability to cooperate and to consent.

Primary outcomes:
measure: Postoperative pain
timeFrame: Postoperative day 1 to 7.
Secondary outcomes:
measure: Pain at the day-case post anaesthesia care unit (dcPACU)
timeFrame: From arrival to the dcPACU until discharged from the dcPACU, up to 5 hours
measure: Postanaesthesia recovery time
timeFrame: From arrival to the dcPACU until discharged from the dcPACU, up to 5 hours
measure: Postoperative nausea and vomiting
timeFrame: Postoperative day 1 to 7.
measure: Daily use of analgesics
timeFrame: Postoperative day 1 to 7.
measure: Location of pain
timeFrame: Day of surgery (preoperative) and postoperative day 1 to 7.
measure: Quality of sleep
timeFrame: Postoperative day 1 to 7.
measure: Well-being
timeFrame: Postoperative day 1 to 7.
measure: Quality of recovery, QoR-15D
timeFrame: Postoperative day 1 and 7.
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Zealand University Hospital, Department of Anaesthesiology
Study officials:
affiliation: Department of Anaesthesiology, Zealand University Hospital, Roskilde, Denmark
name: Anne Sofie N Therkelsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.