PECS and Parasternal Block for Breast Surgery (PARAST)

Observational Study to Evaluated Efficacy of Parasternal and PECS Blocks Association in Breast Surgery

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 Overview

• Status: Completed
• Conditions: Mastectomy; Quadrantectomy

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Italy
  • Cremona
    • Creom, Cremona, Italy, 26100
      • ASST Cremona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing breast surgery

Description

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Anesthetic infiltration	Quantify amount of local anesthetic infiltration from surgeon to get perfect anesthesia	intraoperatory period
Convention in general anesthesia	Number of patients require general anestesia to proceed to surgery	preoperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Rest and in mouvement pain as NRS scale	12 hours postoperatively
PONV	Postoperative nausea/vomiting incidence	12 hours postoperatively

Collaborators and Investigators

• Sponsor: Istituti Ospitalieri di Cremona

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimate): February 6, 2017

Study Record Updates

• Last Update Posted (Estimate): February 6, 2017
• Last Update Submitted That Met QC Criteria: February 3, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: ANECR_01_17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No