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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer Female, Postoperative Pain, Postoperative Nausea and Vomiting

Intervention / Treatment
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* Other: Standardised multimodal pain treatment regimen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer surgery patients.<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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) | Postoperative day 1 to 7. | 
| Daily use of analgesics | Type of drug and dosage | 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) | 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). | Postoperative day 1 to 7. | 
| Well-being | Patient's perceived feelings of sadness (yes/no), restlessness (yes/no), or fatigue (yes/no). | 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. | Postoperative day 1 and 7. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multimodal pain management, Opioid-sparing pain management, Quality of recovery