Impact of Regional Anesthesia on Chronic Post-operative Pain

NCT05876390 | Enrolling By Invitation

• 1 other identifier: 603-11102022
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

breast cancer; breast surgery; oncological breast surgery; multimodal analgesia; chronic postoperative pain

Outcome Measures

Primary Outcomes (1)

• Incidence of chronic postoperative pain after major breast surgery

  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 Outcomes (5)

• Acute post-operative pain

  2, 6, 12 and 24 hours

• Chronic post-operative pain

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

• Quality of life score

  Quality of recovery score (QoR 15)

• Remifentanyl

  Intraoperative

• Opioid

  hour2, hour 6, hour 12 and hour 24 after surgery

Study Arms (1)

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; Drug: analgesia

Interventions

Breast surgery PROCEDURE

Breast surgery

Patients undergoing oncological breast surgery

analgesia DRUG

Multimodal analgesia

Also known as: • loco-regional analgesia + NSAIDs, paracetamol

Patients undergoing oncological breast surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing oncological breast surgery

You may qualify if:

• 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,
• Age \< 18

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

ASST GOM Niguarda

Milan, Lombardy, 20162, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Interventions

Mastectomy, Segmental; Analgesia; Anti-Inflammatory Agents, Non-Steroidal; Acetaminophen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative; Anesthesia and Analgesia; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: May 25, 2023
• Study Start: September 1, 2022
• Primary Completion: September 30, 2024
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

IT (1)