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Completed

NCT Number: NCT04875559

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Zealand University Hospital, Department of Anaesthesiology

Roskilde, 4000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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).

  2. Postanaesthesia recovery time

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

    Length of stay at day-case post anaesthesia care unit (dcPACU).

  3. Postoperative nausea and vomiting

    Time frame: Postoperative day 1 to 7.

    Nausea on average and at worst, measured on a four-point Likert scale (0 = none, 1 = slight, 2 = moderate, 3 = severe). Vomiting (yes/no)

  4. Daily use of analgesics

    Time frame: Postoperative day 1 to 7.

    Type of drug and dosage

  5. Location of pain

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

    Patient's perceived location of pain preoperatively and postoperatively (questionnaire options: breast, side of chest, axilla, arm)

  6. Quality of sleep

    Time frame: Postoperative day 1 to 7.

    Patient's perceived quality of sleep (questionnaire options: good, difficulty of falling asleep, frequent awakenings, no sleep).

  7. Well-being

    Time frame: Postoperative day 1 to 7.

    Patient's perceived feelings of sadness (yes/no), restlessness (yes/no), or fatigue (yes/no).

  8. Quality of recovery, QoR-15D

    Time frame: Postoperative day 1 and 7.

    The QoR-15D is a validated questionnaire (danish version) resulting in a score of 1-150.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 6, 2021
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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