IRACPoP: Impact of Regional Anesthesia on Chronic Post-operative Pain

Sponsor
Niguarda Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05876390
Collaborator
(none)
1,500
1
25
60.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

Detailed Description

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
1500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact of Loco-regional Anesthesia Techniques on Chronic Post-surgery in Breast Oncological Surgery: a Prospective Multicenter Observational Study
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Patients undergoing oncological breast surgery

mastectomy + reconstruction simple quadrantectomy quadrantectomy + sentinel lymph node biopsy quadrantectomy + axillary hollowing bilateral interventions will also be considered

Procedure: Breast surgery
Breast surgery

Drug: analgesia
Multimodal analgesia
Other Names:
  • • loco-regional analgesia + NSAIDs, paracetamol
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence of chronic postoperative pain after major breast surgery [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 Outcome Measures

    1. Acute post-operative pain [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 [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 [Quality of recovery score (QoR 15)]

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

    4. Remifentanyl [Intraoperative]

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

    5. Opioid [hour2, hour 6, hour 12 and hour 24 after surgery]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ASST GOM Niguarda Milano Lombardia Italy 20162

    Sponsors and Collaborators

    • Niguarda Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Niguarda Hospital
    ClinicalTrials.gov Identifier:
    NCT05876390
    Other Study ID Numbers:
    • 603-11102022
    First Posted:
    May 25, 2023
    Last Update Posted:
    May 25, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Niguarda Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 25, 2023