Reconstruction Breast Surgery Clinical Trial
— PVBvsPECSOfficial title:
Thoracic Paravertebral Block Versus Pectoral Nerves Block (Modified PECS) Block in Breast Surgery
| Verified date | February 2017 |
| Source | Istituti Ospitalieri di Cremona |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 55 |
| Est. completion date | February 2017 |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Azienda Ospedaliera Istituti Ospitalieri di Cremona | Cremona | CR |
| Lead Sponsor | Collaborator |
|---|---|
| Istituti Ospitalieri di Cremona |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PCA morphine consumption in the two groups within the first 24 postoperative hours | 24 hours postoperatively | ||
| Secondary | Numerical Rating Scores for pain at rest and during movement | 24 hours postoperatively | ||
| Secondary | Postoperative nausea/vomiting incidence | 24 hours postoperatively | ||
| Secondary | Time of performance | During procedure execution | ||
| Secondary | Propofol consumption in intraoperative period | Propofol consumption in intraoperative period to maintain total intravenous general anesthesia (BIS target 40-60). Propofol consumption in mg/kg/h | Intraoperative period | |
| Secondary | Opioids (remifentanyl) consumption in 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 | Intraoperative period | |
| Secondary | Numerical Rating Scores during procedure execution | During procedure execution |