Block REducing Pain After Surgery Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Chronic Pain Post-Procedural

Intervention / Treatment
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* Procedure: PECS block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: programmed breast surgery informed consent Exclusion Criteria: bilateral breast surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 86 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PECS block+ General anesthesia<br>Patients undergoing mastectomy, partial mastectomy and/or axillary clearance who received PECS block AND general anesthesia for the surgery. | Procedure: PECS block<br>* It consists in injection of 20-30 ml of local anesthetic between pectoral minor, pectoral major, and serratus muscles.<br>|
| General anesthesia<br>Patients undergoing mastectomy, partial mastectomy and/or axillary clearance who received general anesthesia only for the surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic pain at 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 | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic pain at 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 | three months | 
| Chronic pain at 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 | nine months | 
| Chronic pain at 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 | twelve months | 
| Difference in opioid consumption during surgery | Difference in opioid consumption during surgery (Fentanyl as mcg/kg/h; Remifentanil as mcg/kg/min) | day of surgery | 
| Difference in pain in the first 24 hours after surgery | maximum and mean NRS score in the first 24 hours after surgery | first 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Regional ;PECS block