Observational Study to Evaluated Efficacy of Parasternal and PECS Blocks Association in Breast Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Local Anesthetic infiltration
Study Overview
Brief Summary
Propose to evaluate efficacy of association between US guide parasternal block and pectorals nerves block (PECS) as anesthetic option for breast surgery (medial quadrantectomy and simple mastectomy).
All patients undergoing medial quadrantectomy and simple mastectomy in 6 months period will be observed.
All patients receive: US guide parasternal block at T4 and T6 space with 6ml of ropivacaine 0,75% and PECS type 2 block performed with 24ml of ropivacaine 0,75%.
During surgery patients receive light sedation with continuous infusion of propofol
Will be observed:
Additional local anesthetic infiltration from surgeon. Pain at rest and during movement quantified as Numerical Rating Scores (0-10) during the first 12 hours postoperatively.
Eventual side effects such as nausea/vomiting.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age> 18 years;
- •ASA score I - II - III;
- •undergoing elective medial quadrantectomy breast surgery;
- •undergoing elective mastectomy not reconstruction breast surgery;
- •signed informed consent;
Exclusion Criteria
- •chronic therapy with opioids/ antidepressants;
- •urgent/emergent surgery;
- •postoperative transfer to the intensive care unit;
- •known allergy to any drug medication;
- •local skin infection;
- •epilepsy;
- •alcohol or drug abuse;
Outcomes
Primary Outcomes
Local Anesthetic infiltration
Time Frame: intraoperatory period
Quantify amount of local anesthetic infiltration from surgeon to get perfect anesthesia
Convention in general anesthesia
Time Frame: preoperative period
Number of patients require general anestesia to proceed to surgery
Secondary Outcomes
- Pain(12 hours postoperatively)
- PONV(12 hours postoperatively)
Investigators
Erika Basso Ricci
Anesthetist
Istituti Ospitalieri di Cremona