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Enrolling by Invitation

NCT Number: NCT05876390

Impact of Regional Anesthesia on Chronic Post-operative Pain

Approximately 55,000 cases of breast cancer are diagnosed in Italy every year and the first-line therapy for carcinoma in situ, stage I, II and IIIA is surgical removal of the tumour. The incidence of chronic pain after breast cancer surgery is confirmed around 30%. This study aims to evaluate the impact of loco-regional anesthesia techniques in the context of multimodal analgesia in the prevention of chronic pain post-oncological breast surgery

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Key information

About this study

Approximately 55,000 cases of breast cancer are diagnosed in Italy every year and the first-line therapy for carcinoma in situ, stage I, II and IIIA is surgical removal of the tumour. The incidence of chronic pain after breast cancer surgery is confirmed around 30%.Persistent postsurgical pain, defined in the ICD-11 as pain that develops or increases in intensity after a surgical procedure or tissue damage and persists beyond the healing process for at least 3 months after the initial event and is considered a complication of surgery.

Several pharmacological and non-pharmacological interventions have been proposed for the prevention of the development of this complication of surgical interventions, including the intraoperative use of local anesthesia techniques in the context of multimodal analgesia.

The purpose of this multicenter prospective observational study is to evaluate, through the propensity score methodology, how much the use of loco-regional anesthesia techniques can improve the outcome, in terms of the development of chronic post-surgical pain, of patients undergoing to oncological breast surgery

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18
  • Oncological breast surgery:
  • simple mastectomy,
  • mastectomy + sentinel lymph node biopsy,
  • mastectomy + axillary hollowing,
  • mastectomy + reconstruction,
  • simple quadrantectomy,
  • quadrantectomy + sentinel lymph node biopsy,
  • quadrantectomy + axillary hollowing,
  • bilateral interventions will also be considered) Exclusion
  • Age < 18

Treatment and study plan

Breast surgery

Procedure

Breast surgery

analgesia

Drug

Multimodal analgesia

Other names: • loco-regional analgesia + NSAIDs, paracetamol

Primary outcomes

  1. Incidence of chronic postoperative pain after major breast surgery

    Time frame: 6 - 12 months

    Incidence of chronic post-surgical pain after major breast surgery (definition: pain that persists at least 3 months after surgery; pain that was not present before surgery or that has different characteristics from pain before surgery or that has increased intensity than before the operation; the pain is localized in the area of the surgical site or in its radiation; other possible causes of pain are excluded)

Secondary outcomes

  1. Acute post-operative pain

    Time frame: 2, 6, 12 and 24 hours

    Acute postoperative pain. NRS Numerical Rating Scale (0-10; 0 =better 10= worse outcome)

  2. Chronic post-operative pain

    Time frame: 3,6,9,12 months) at rest and on mobilization

    Pain both at rest and on mobilization month3, month6, month9 and month12 after surgery. Numerical Rating Scale (0-10; 0 =better 10= worse outcome)

  3. Quality of life score

    Time frame: Quality of recovery score (QoR 15)

    Quality of recovery score-15 (QoR 15; scale 0-150; 0=better 150=worse outcome)

  4. Remifentanyl

    Time frame: Intraoperative

    Intraoperative use of remifentanil. Intraoperative quantitative use of remifentanyl (total micrograms; the lesser the better)

  5. Opioid

    Time frame: hour2, hour 6, hour 12 and hour 24 after surgery

    Postoperative opioid use. (opioid oral morphine milligram equivalent (MME); the lesser the better)

Sponsors and collaborators

Lead sponsor

Niguarda Hospital

Other

Registry information

Official study title

Impact of Loco-regional Anesthesia Techniques on Chronic Post-surgery in Breast Oncological Surgery: a Prospective Multicenter Observational Study

Acronym: IRACPoP

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
May 25, 2023
Registry last updated
Apr 16, 2026

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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