Multimodal Pain Treatment for Breast Cancer Surgery - a Prospective Cohort Study

NCT04875559 | Completed DMC

• 1 other identifier: REG-028-2021
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

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)

Conditions

Breast Cancer Female; Postoperative Pain; Postoperative Nausea and Vomiting

Keywords

Multimodal pain management; Opioid-sparing pain management; Quality of recovery

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  Postoperative pain scored on the 11-point numeric rating scale, NRS, (score 0 = no pain, 10 = worst pain imaginable). Average pain, worst pain and pain during arm abduction to an angle of 90 degrees out from the body.

  Postoperative day 1 to 7.

Secondary Outcomes (8)

• Pain at the day-case post anaesthesia care unit (dcPACU)

  From arrival to the dcPACU until discharged from the dcPACU, up to 5 hours

• Postanaesthesia recovery time

  From arrival to the dcPACU until discharged from the dcPACU, up to 5 hours

• Postoperative nausea and vomiting

  Postoperative day 1 to 7.

• Daily use of analgesics

  Postoperative day 1 to 7.

• Location of pain

  Day of surgery (preoperative) and postoperative day 1 to 7.

Study Arms (1)

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.

Other: Standardised multimodal pain treatment regimen

Interventions

Standardised multimodal pain treatment regimen OTHER

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

Breast cancer surgery patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital, Department of Anaesthesiology

Roskilde, 4000, Denmark

Location

Related Publications (10)

• 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.

  PMID: 33538338 BACKGROUND

• 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.

  PMID: 30100074 BACKGROUND

• 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.

  PMID: 30700614 BACKGROUND

• 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.

  PMID: 32816362 BACKGROUND

• 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.

  PMID: 20935616 BACKGROUND

• 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.

  PMID: 32443289 BACKGROUND

• 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.

  PMID: 19863218 BACKGROUND

• 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.

  PMID: 31984479 BACKGROUND

• 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.

  PMID: 31977520 BACKGROUND

• 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.

  PMID: 40838964 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Officials

• Anne Sofie N Therkelsen, MD

  Department of Anaesthesiology, Zealand University Hospital, Roskilde, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: May 6, 2021
• Study Start: April 19, 2021
• Primary Completion: August 4, 2022
• Study Completion: August 18, 2022
• Last Updated: July 14, 2023

Record last verified: 2023-07

Locations

DK (1)