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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04875559
• Other study ID #: REG-028-2021
• Status: Completed
• Start date: April 19, 2021
• Est. completion date: August 18, 2022

Study information

• Verified date: July 2023
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. (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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: August 18, 2022
• Est. primary completion date: August 4, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Vomiting

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

Locations

Country	Name	City	State
Denmark	Zealand University Hospital, Department of Anaesthesiology	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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