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Completed

NCT Number: NCT03448913

Block REducing Pain After Surgery Trial

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.

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Key information

Conditions

Chronic Pain Post-Procedural

Age range

18 year–86 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Padova

Padova, 35127, Italy

About this study

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.

Who can participate

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

Inclusion criteria

  • programmed breast surgery
  • informed consent

Exclusion criteria

  • bilateral breast surgery

Treatment and study plan

PECS block

Procedure

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

Primary outcomes

  1. Chronic pain at six months

    Time frame: six months

    Presence 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 outcomes

  1. Chronic pain at three months

    Time frame: three months

    Presence 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

  2. Chronic pain at nine months

    Time frame: nine months

    Presence 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

  3. Chronic pain at twelve months

    Time frame: twelve months

    Presence 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

  4. Difference in opioid consumption during surgery

    Time frame: day of surgery

    Difference in opioid consumption during surgery (Fentanyl as mcg/kg/h; Remifentanil as mcg/kg/min)

  5. Difference in pain in the first 24 hours after surgery

    Time frame: first 24 hours after surgery

    maximum and mean NRS score in the first 24 hours after surgery

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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)

Acronym: BREAST

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2018
Registry last updated
Mar 12, 2019

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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