PECS and Parasternal Block for Breast Surgery

Completed

• Conditions: Quadrantectomy; Mastectomy

• Registration Number: NCT03043755
• Lead Sponsor: Istituti Ospitalieri di Cremona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Primary Completion: 2016-12
• Status Verified: 2017-02
• Study Completion: 2017-02
• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-03
• Last Update Submitted: 2017-02-03
• Study First Posted: 2017-02-06
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain	12 hours postoperatively	Rest and in mouvement pain as NRS scale
PONV	12 hours postoperatively	Postoperative nausea/vomiting incidence

Trial Locations

Locations (1)

ASST Cremona; 🇮🇹 Creom, Cremona, Italy