Reconstruction Breast Surgery
Conditions
Brief summary
Purpose to compare paravertebral thoracic block (PVB) and pectorals nerves block as analgesic option for major breast surgery. 102 patients undergoing reconstruction breast surgery will be randomized into two groups: Group PVB (n=51) will receive US guided paravertebral thoracic block (between T2-T6) performed with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction. Morphine patient control analgesia (PCA) with loading dose i.v. titrated by the PACU nurse if pain \> 5/10 at rest Group PECS (n=51) will receive US guided pectorals nerves block performed with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction. Morphine PCA with loading dose i.v. titrated by the post-anesthesia care unit (PACU) nurse if pain \> 5/10 at rest Primary Outcome Measures: Morphine consumption (mg) (Time Frame: 24 hours) in two Groups Secondary Outcome Measures: Pain at rest and during movement quantified as Numerical Rating Scores (0-10) during the first 24 hours postoperatively. Eventual side effects such as nausea/vomiting. Time necessary to perform the procedure. Pain during procedure execution quantified as Numerical Rating Scores (0-10) Hypnotic and opioids intraoperative consumption to ensure general anesthesia with Bispectral Index between 40 and 60.
Interventions
PROCEDUREParavertebral Thoracic block
PROCEDUREPectorals nerve block
DRUGMorphine
Sponsors
Istituti Ospitalieri di Cremona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age\> 18 years * ASA score I - II - III * undergoing elective 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCA morphine consumption in the two groups within the first 24 postoperative hours | 24 hours postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea/vomiting incidence | 24 hours postoperatively | — |
| Time of performance | During procedure execution | — |
| Numerical Rating Scores for pain at rest and during movement | 24 hours postoperatively | — |
| Opioids (remifentanyl) consumption in intraoperative period | Intraoperative period | Opioids (remifentanyl) consumption in intraoperative period to maintain total intravenous general anesthesia (systolic blood pression target: reduction of 20% from base line value). Remifentanyl in mcg/kg/h |
| Numerical Rating Scores during procedure execution | During procedure execution | — |
| Propofol consumption in intraoperative period | Intraoperative period | Propofol consumption in intraoperative period to maintain total intravenous general anesthesia (BIS target 40-60). Propofol consumption in mg/kg/h |
Countries
Italy
Outcome results
None listed