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Completed

NCT Number: NCT03043755

PECS and Parasternal Block for 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.

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Key information

Conditions

Quadrantectomy Mastectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

ASST Cremona

Creom, Cremona, 26100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  1. Local Anesthetic infiltration

    Time frame: intraoperatory period

    Quantify amount of local anesthetic infiltration from surgeon to get perfect anesthesia

  2. Convention in general anesthesia

    Time frame: preoperative period

    Number of patients require general anestesia to proceed to surgery

Secondary outcomes

  1. Pain

    Time frame: 12 hours postoperatively

    Rest and in mouvement pain as NRS scale

  2. PONV

    Time frame: 12 hours postoperatively

    Postoperative nausea/vomiting incidence

Sponsors and collaborators

Lead sponsor

Istituti Ospitalieri di Cremona

Other

Registry information

Official study title

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

Acronym: PARAST

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Feb 6, 2017
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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