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

July 12, 2023 updated by: Zealand University Hospital
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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Roskilde, Denmark, 4000
        • Zealand University Hospital, Department of Anaesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative day 1 to 7.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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
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)
Postoperative day 1 to 7.
Daily use of analgesics
Time Frame: Postoperative day 1 to 7.
Type of drug and dosage
Postoperative day 1 to 7.
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)
Day of surgery (preoperative) and postoperative day 1 to 7.
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).
Postoperative day 1 to 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).
Postoperative day 1 to 7.
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.
Postoperative day 1 and 7.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Investigators

  • Principal Investigator: Anne Sofie N Therkelsen, MD, Department of Anaesthesiology, Zealand University Hospital, Roskilde, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2021

Primary Completion (Actual)

August 4, 2022

Study Completion (Actual)

August 18, 2022

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG-028-2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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