Breast Cancer FemaleNCT04875559
Multimodal Pain Treatment for Breast Cancer Surgery - a Prospective Cohort Study
An observational study of Breast Cancer Female and Postoperative Pain, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Postoperative Pain, Postoperative Nausea and Vomiting
- What is being tested?
- Standardised multimodal pain treatment regimen
- Type of treatment
- Injection or infusion
- How many people
- 236 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Apr 2021to 18 Aug 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Not able to speak, read, or understand Danish.
- Inability to cooperate and to consent.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Zealand University Hospital, Department of Anaesthesiology
Roskilde, 4000
About this study
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)
Read the 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.
- Being tested
- Standardised multimodal pain treatment regimen
- Keywords
- Multimodal pain management, Opioid-sparing pain management, Quality of recovery
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardised multimodal pain treatment regimenOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standardised multimodal pain treatment regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative day 1 to 7.
Secondary outcomes (8)
Pain at the day-case post anaesthesia care unit (dcPACU)
Pain at dcPACU arrival and worst pain during dcPACU stay, scored on the 11-point numeric rating scale, NRS, (score 0 = no pain, 10 = worst pain imaginable).
Measured: From arrival to the dcPACU until discharged from the dcPACU, up to 5 hours
Postanaesthesia recovery time
Length of stay at day-case post anaesthesia care unit (dcPACU).
Measured: From arrival to the dcPACU until discharged from the dcPACU, up to 5 hours
Postoperative nausea and vomiting
Nausea on average and at worst, measured on a four-point Likert scale (0 = none, 1 = slight, 2 = moderate, 3 = severe). Vomiting (yes/no)
Measured: Postoperative day 1 to 7.
Daily use of analgesics
Type of drug and dosage
Measured: Postoperative day 1 to 7.
Location of pain
Patient's perceived location of pain preoperatively and postoperatively (questionnaire options: breast, side of chest, axilla, arm)
Measured: Day of surgery (preoperative) and postoperative day 1 to 7.
Quality of sleep
Patient's perceived quality of sleep (questionnaire options: good, difficulty of falling asleep, frequent awakenings, no sleep).
Measured: Postoperative day 1 to 7.
Well-being
Patient's perceived feelings of sadness (yes/no), restlessness (yes/no), or fatigue (yes/no).
Measured: Postoperative day 1 to 7.
Quality of recovery, QoR-15D
The QoR-15D is a validated questionnaire (danish version) resulting in a score of 1-150.
Measured: Postoperative day 1 and 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start19 Apr 2021
- Primary completion4 Aug 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Sofie N Therkelsen, MD, Principal investigator, Department of Anaesthesiology, Zealand University Hospital, Roskilde, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875559
- Sponsor's protocol ID
- REG-028-2021
- Status last verified
- Jul 2023
- First submitted
- 19 Apr 2021
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33538338Moo 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.
PubMed 30100074Habib 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.
PubMed 30700614Lepot 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.
PubMed 32816362Gartner 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.
PubMed 20935616Gong 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.
PubMed 32443289Sagen 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.
PubMed 19863218Jacobs 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.
PubMed 31984479Steinthorsdottir 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.
PubMed 31977520Petersen 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.
PubMed 40838964
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Pain Treatment for Breast Cancer Surgery - a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04875559
- Acronym / sponsor ID
- REG-028-2021
- Keywords
- Multimodal pain management, Opioid-sparing pain management, Quality of recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer surgery patients. | – | Other: Standardised multimodal pain treatment regimenPatients scheduled for day-case unilateral breast conserving surgery or mastectomy with or without axillary lymph node dissection or sentinel lymph node biopsy. No intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Not able to speak, read, or understand Danish.
- Inability to cooperate and to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardised multimodal pain treatment regimenPreoperatively: * 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 | Other | Breast cancer surgery patients. |
Primary outcome
Postoperative pain
Time frame: Postoperative day 1 to 7.
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.
8 secondary outcomes
Pain at the day-case post anaesthesia care unit (dcPACU)
Time frame: From arrival to the dcPACU until discharged from the dcPACU, up to 5 hours
Postanaesthesia recovery time
Time frame: From arrival to the dcPACU until discharged from the dcPACU, up to 5 hours
Postoperative nausea and vomiting
Time frame: Postoperative day 1 to 7.
Daily use of analgesics
Time frame: Postoperative day 1 to 7.
Location of pain
Time frame: Day of surgery (preoperative) and postoperative day 1 to 7.
Quality of sleep
Time frame: Postoperative day 1 to 7.
Well-being
Time frame: Postoperative day 1 to 7.
Quality of recovery, QoR-15D
Time frame: Postoperative day 1 and 7.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Background: PubMed 33538338Sung 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.
- Background: PubMed 30100074Moo 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.
- Background: PubMed 30700614Habib 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.
- Background: PubMed 32816362Lepot 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.
- Background: PubMed 20935616Gartner 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.
- Background: PubMed 32443289Gong 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.
- Background: PubMed 19863218Sagen 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.
- Background: PubMed 31984479Jacobs 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.
- Background: PubMed 31977520Steinthorsdottir 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.
- Derived from this study: PubMed 40838964Petersen 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.
Related trials for Breast Cancer Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Sofie N Therkelsen, MD principal investigator
Department of Anaesthesiology, Zealand University Hospital, Roskilde, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female and Postoperative Pain, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: Postoperative day 1 to 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04875559, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.