Impact of Regional Anesthesia on Chronic Post-operative Pain

Breast Cancer Clinical Trial

— IRACPoP  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05876390
• Other study ID #: 603-11102022
• Status: Enrolling by invitation
• Start date: September 1, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: November 2023
• Source: Niguarda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1500
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Breast surgery
Breast surgery

Drug:
• analgesia
Multimodal analgesia

Locations

Country	Name	City	State
Italy	ASST GOM Niguarda	Milano	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Niguarda Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acute post-operative pain	Acute postoperative pain. NRS Numerical Rating Scale (0-10; 0 =better 10= worse outcome)	2, 6, 12 and 24 hours
Secondary	Chronic post-operative pain	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
Secondary	Quality of life score	Quality of recovery score-15 (QoR 15; scale 0-150; 0=better 150=worse outcome)	Quality of recovery score (QoR 15)
Secondary	Remifentanyl	Intraoperative use of remifentanil. Intraoperative quantitative use of remifentanyl (total micrograms; the lesser the better)	Intraoperative
Secondary	Opioid	Postoperative opioid use. (opioid oral morphine milligram equivalent (MME); the lesser the better)	hour2, hour 6, hour 12 and hour 24 after surgery