PECS and Parasternal Block for Breast Surgery

Mastectomy Clinical Trial

— PARAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03043755
• Other study ID #: ANECR_01_17
• Status: Completed
• Phase: N/A
• First received: February 2, 2017
• Last updated: February 3, 2017
• Start date: July 2016
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: Istituti Ospitalieri di Cremona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Mastectomy
• Quadrantectomy

Locations

Country	Name	City	State
Italy	ASST Cremona	Creom	Cremona

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Ospitalieri di Cremona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Anesthetic infiltration	Quantify amount of local anesthetic infiltration from surgeon to get perfect anesthesia	intraoperatory period
Primary	Convention in general anesthesia	Number of patients require general anestesia to proceed to surgery	preoperative period
Secondary	Pain	Rest and in mouvement pain as NRS scale	12 hours postoperatively
Secondary	PONV	Postoperative nausea/vomiting incidence	12 hours postoperatively