Clinical trial NCT02677571: PVB vs PECS Block in Breast Surgery
Official title: Thoracic Paravertebral Block Versus Pectoral Nerves Block (Modified PECS) Block in Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reconstruction Breast Surgery
Lead sponsor: Istituti Ospitalieri di Cremona
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: PCA morphine consumption in the two groups within the first 24 postoperative hours
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Numerical Rating Scores for pain at rest and during movement
timeFrame: 24 hours postoperatively
measure: Postoperative nausea/vomiting incidence
timeFrame: 24 hours postoperatively
measure: Time of performance
timeFrame: During procedure execution
measure: Propofol consumption in intraoperative period
timeFrame: Intraoperative period
measure: Opioids (remifentanyl) consumption in intraoperative period
timeFrame: Intraoperative period
measure: Numerical Rating Scores during procedure execution
timeFrame: During procedure execution
Other outcomes:
Locations:
city: Cremona
country: Italy
facility: Azienda Ospedaliera Istituti Ospitalieri di Cremona
state: CR
Study officials:
affiliation: Istituti Ospedalieri di Cremona
name: Giorgio F Danelli, MD
role: STUDY_DIRECTOR
References: