Impact of Regional Anesthesia on Chronic Post-operative Pain

Overview

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

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

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: September 30, 2023

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

Interventions

• Procedure: Breast surgery
  • Breast surgery
• Drug: analgesia
  • Multimodal analgesia

Arms, Groups and Cohorts

• Patients undergoing oncological breast surgery
  • mastectomy + reconstruction simple quadrantectomy quadrantectomy + sentinel lymph node biopsy quadrantectomy + axillary hollowing bilateral interventions will also be considered

Clinical Trial Outcome Measures

Primary Measures

• 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 Measures

• 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)
• 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)
• 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)
• Remifentanyl
  • Time Frame: Intraoperative
  • Intraoperative use of remifentanil. Intraoperative quantitative use of remifentanyl (total micrograms; the lesser the better)
• 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Niguarda Hospital
• Provider of Information About this Clinical Study
  • Sponsor