An observational study in Chronic Pain Post-Procedural, sponsored by University of Padova. Completed at 1 site in Italy. Open to participants aged 18 Years to 86 Years. Per ClinicalTrials.gov, last updated 2019-03-12.
Sponsored by University of Padova · Observational
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.
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.
Patients needing breast surgery (mastectomy, partial mastectomy and/or axillary clearence)
Exclusion Criteria:
Patients undergoing mastectomy, partial mastectomy and/or axillary clearance who received PECS block AND general anesthesia for the surgery.
Procedure: PECS block
Patients undergoing mastectomy, partial mastectomy and/or axillary clearance who received general anesthesia only for the surgery.
It consists in injection of 20-30 ml of local anesthetic between pectoral minor, pectoral major, and serratus muscles.
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
Time frame: six months
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
Time frame: 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
Time frame: 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
Time frame: twelve months
Difference in opioid consumption during surgery
Difference in opioid consumption during surgery (Fentanyl as mcg/kg/h; Remifentanil as mcg/kg/min)
Time frame: 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
Time frame: first 24 hours after surgery
Plan to share: Undecided — De.identified individual participant data for all primary and secondary measures will be probably be made available
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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University of Padova