Impact of Regional Anesthesia on Chronic Post-operative Pain (IRACPoP)

November 8, 2023 updated by: Niguarda Hospital

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

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

Study Locations

  • Italy
    • Lombardia
      • Milano, Lombardia, Italy, 20162
        • ASST GOM Niguarda

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing oncological breast surgery

Description

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

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 - 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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, 6, 12 and 24 hours
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)
3,6,9,12 months) at rest and on mobilization
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)
Quality of recovery score (QoR 15)
Remifentanyl
Time Frame: Intraoperative
Intraoperative use of remifentanil. Intraoperative quantitative use of remifentanyl (total micrograms; the lesser the better)
Intraoperative
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)
hour2, hour 6, hour 12 and hour 24 after surgery

Collaborators and Investigators

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

Sponsor

Niguarda Hospital

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)

September 1, 2022

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 603-11102022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The results obtained will be used for a scientific publication and for the elaboration of a specialist degree thesis in Anesthesia and Intensive Care

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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