Trials / Completed
CompletedNCT02677571
PVB vs PECS Block in Breast Surgery
Thoracic Paravertebral Block Versus Pectoral Nerves Block (Modified PECS) Block in Breast Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Istituti Ospitalieri di Cremona · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Paravertebral Thoracic block | |
| PROCEDURE | Pectorals nerve block | |
| DRUG | Levobupivacaine 0.25% | |
| DRUG | Morphine |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2017-01-01
- Completion
- 2017-02-01
- First posted
- 2016-02-09
- Last updated
- 2017-02-03
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT02677571. Inclusion in this directory is not an endorsement.