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Block REducing Pain After Surgery Trial

Prospective Observational Single-centre Study: Difference in the Incidence of Chronic Pain After Breast Surgery Between General Anesthesia and General Anesthesia Associated With PECS Block (Block REducing Pain After Surgery Trial)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03448913
Acronym
BREAST
Enrollment
140
Registered
2018-02-28
Start date
2018-02-01
Completion date
2019-03-01
Last updated
2019-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain Post-Procedural

Keywords

Anesthesia, Regional ;PECS block

Brief summary

This observational study evaluates difference in chronic pain after six months from surgery between patients who received PECS block and general anesthesia versus general anesthesia alone.

Detailed description

PECS block is used as a pain relief technique during breast surgery. However at the actual state of knowledge there is no strong evidence that its use could lower incidence of chronic pain compared to general anesthesia alone. Moreover for its use an adequate skill with ultrasound machine is required. For this reason only some anesthesiologists in our reality use this technique it in clinical practice.

Interventions

PROCEDUREPECS block

It consists in injection of 20-30 ml of local anesthetic between pectoral minor, pectoral major, and serratus muscles.

Sponsors

University of Padova
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 86 Years

Inclusion criteria

* programmed breast surgery * informed consent

Exclusion criteria

* bilateral breast surgery

Design outcomes

Primary

MeasureTime frameDescription
Chronic pain at six monthssix monthsPresence of chronic pain at six months after surgery. For this purpose patient will be asked to report presence of pain on breast, neck, axilla or arm. If patient will report pain a further question about intensity (NRS) and quality (we will ask to patient to describe with words from one to three the pain). Furthermore we will ask to patient if he had take any action (eg drugs) to treat pain

Secondary

MeasureTime frameDescription
Chronic pain at three monthsthree monthsPresence of chronic pain at three months after surgery. For this purpose patient will be asked to report presence of pain on breast, neck, axilla or arm. If patient will report pain a further question about intensity (NRS) and quality (we will ask to patient to describe with words from one to three the pain). Furthermore we will ask to patient if he had take any action (eg drugs) to treat pain
Chronic pain at nine monthsnine monthsPresence of chronic pain at nine months after surgery. For this purpose patient will be asked to report presence of pain on breast, neck, axilla or arm. If patient will report pain a further question about intensity (NRS) and quality (we will ask to patient to describe with words from one to three the pain). Furthermore we will ask to patient if he had take any action (eg drugs) to treat pain
Chronic pain at twelve monthstwelve monthsPresence of chronic pain at twelve months after surgery. For this purpose patient will be asked to report presence of pain on breast, neck, axilla or arm. If patient will report pain a further question about intensity (NRS) and quality (we will ask to patient to describe with words from one to three the pain). Furthermore we will ask to patient if he had take any action (eg drugs) to treat pain
Difference in opioid consumption during surgeryday of surgeryDifference in opioid consumption during surgery (Fentanyl as mcg/kg/h; Remifentanil as mcg/kg/min)
Difference in pain in the first 24 hours after surgeryfirst 24 hours after surgerymaximum and mean NRS score in the first 24 hours after surgery

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026