PECS and Parasternal Block for Breast Surgery

NCT03043755 | Completed

• 1 other identifier: ANECR_01_17
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Quadrantectomy; Mastectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pain

  12 hours postoperatively

• PONV

  12 hours postoperatively

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing breast surgery

You may qualify if:

• age\> 18 years;
• ASA score I - II - III;
• undergoing elective medial quadrantectomy breast surgery;
• undergoing elective mastectomy not reconstruction breast surgery;
• signed informed consent;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Istituti Ospitalieri di Cremona: lead

Study Sites (1)

ASST Cremona

Creom, Cremona, 26100, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthetist

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 6, 2017
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: February 6, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)