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Chronic adverse effects after an axillary lymphadenectomy in breast cancer patients after administering weaker and stronger postoperative analgesia: results of a prospective double-blind randomized study

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Abstract

Purpose

The aim of this study was to compare the rate of chronic adverse effects after a weaker and stronger postoperative analgesia.

Methods

A prospective double-blind randomized study included 117 breast cancer patients receiving tramadol for pain relief for 4 weeks after an axillary lymphadenectomy from 2015 to 2018. Patients with a larger dose received 75/650 mg of tramadol with paracetamol every 8 h and a group with a lower dose received 37.5/325 mg of tramadol with paracetamol every 8 h from the 2nd to the 29th postoperative day. 1 year after surgery, patients were evaluated for the presence of neuropathic pain, chronic pain, arm symptoms and lymphedema.

Results

There was a trend for a lower rate of neuropathic pain after stronger analgesia in comparison to weaker analgesia (p = 0.059). Chronic pain was present in 18% of patients 1 year after the lymphadenectomy. There was no difference in the rate of chronic pain after stronger and weaker postoperative analgesia. Patients had less arm symptoms after a stronger analgesia than after a weaker analgesia (p = 0.02). Furthermore, there was a trend for a lower rate of lymphedema of the forearm after a stronger analgesia than after a lower analgesia (p = 0.078).

Conclusions

The patients who received a stronger postoperative analgesia had less arm symptoms and a better quality of life in comparison to patients who received a weaker analgesia. The patients who received a stronger postoperative analgesia had a statistical trend for less neuropathic pain in comparison to patients who received a weaker analgesia.

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Acknowledgements

The authors thank our research nurses Tjasa Pecnik and Milanka Urankar and research fellow Jerica Novak for their excellent work.

Funding

This study was partly funded by the Ministry of Education, Science and Sport of the Republic of Slovenia, Grant No. P3-0289. This work has been partly funded by an unrestricted research Grant (Trial KCT 04/2015-DORETAonko/si) from Krka, d.d., Novo mesto which also supplied the investigated medicines.

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Authors and Affiliations

  1. Department of Surgical Oncology, Institute of Oncology, Zaloska 2, 1000, Ljubljana, Slovenia

    Nikola Besic

  2. Faculty of Mathematics and Physics, University of Ljubljana, 1000, Ljubljana, Slovenia

    Jaka Smrekar

  3. Department of Anesthesiology, Institute of Oncology, Zaloska 2, 1000, Ljubljana, Slovenia

    Branka Strazisar

Authors
  1. Nikola Besic
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Corresponding author

Correspondence to Nikola Besic.

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Conflict of interest

N. Besic and B. Strazisar have received a research Grant Trial KCT 04/2015-DORETAonko/si from the pharmaceutical company Krka d.d. Novo mesto. J. Smrekar has received a honorarium for the statistical analysis of our study from the pharmaceutical company Krka d.d. Novo mesto.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study Trial KCT 04/2015-DORETAonko/si, EudraCT Number: 2015-000992-28 met the guidelines of their responsible governmental agency and was reviewed and approved by The National Medical Ethics Committee of the Republic of Slovenia (Approval number 32/03/15). Our study was approved by the Institutional Review Board of the Institute of Oncology Ljubljana.

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Informed consent was obtained from all individual participants included in the study.

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Besic, N., Smrekar, J. & Strazisar, B. Chronic adverse effects after an axillary lymphadenectomy in breast cancer patients after administering weaker and stronger postoperative analgesia: results of a prospective double-blind randomized study. Breast Cancer Res Treat 182, 655–663 (2020). https://doi.org/10.1007/s10549-020-05713-3

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  • DOI: https://doi.org/10.1007/s10549-020-05713-3

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