Clinical trial NCT05876390: Impact of Regional Anesthesia on Chronic Post-operative Pain
Official title: Impact of Loco-regional Anesthesia Techniques on Chronic Post-surgery in Breast Oncological Surgery: a Prospective Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Cancer
Keywords: breast cancer
breast surgery
oncological breast surgery
multimodal analgesia
chronic postoperative pain
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing oncological breast surgery

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of chronic postoperative pain after major breast surgery
timeFrame: 6 - 12 months
Secondary outcomes:
measure: Acute post-operative pain
timeFrame: 2, 6, 12 and 24 hours
measure: Chronic post-operative pain
timeFrame: 3,6,9,12 months) at rest and on mobilization
measure: Quality of life score
timeFrame: Quality of recovery score (QoR 15)
measure: Remifentanyl
timeFrame: Intraoperative
measure: Opioid
timeFrame: hour2, hour 6, hour 12 and hour 24 after surgery
Other outcomes:
Locations:
city: Milano
country: Italy
facility: ASST GOM Niguarda
state: Lombardia
Study officials:
References: