PVB vs PECS Block in Breast Surgery (PVBvsPECS)

Thoracic Paravertebral Block Versus Pectoral Nerves Block (Modified PECS) Block in Breast Surgery

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.

Study Overview

• Status: Completed
• Conditions: Reconstruction Breast Surgery
• Intervention / Treatment: Procedure: Paravertebral Thoracic block; Drug: Levobupivacaine 0.25%; Drug: Morphine; Procedure: Pectorals nerve block

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • CR
    • Cremona, CR, Italy, 26100
      • Azienda Ospedaliera Istituti Ospitalieri di Cremona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PVB; 51 patients receiving US guided homolateral paravertebral thoracic block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).	Procedure: Paravertebral Thoracic block; Drug: Levobupivacaine 0.25%; Drug: Morphine
Experimental: PECS; 51 patients receiving US guided pectorals nerve block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).	Drug: Levobupivacaine 0.25%; Drug: Morphine; Procedure: Pectorals nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PCA morphine consumption in the two groups within the first 24 postoperative hours	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scores for pain at rest and during movement		24 hours postoperatively
Postoperative nausea/vomiting incidence		24 hours postoperatively
Time of performance		During procedure execution
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
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
Numerical Rating Scores during procedure execution		During procedure execution

Collaborators and Investigators

• Sponsor: Istituti Ospitalieri di Cremona
• Investigators: Study Director: Giorgio F Danelli, MD, Istituti Ospedalieri di Cremona

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: January 23, 2016
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimate): February 9, 2016

Study Record Updates

• Last Update Posted (Estimate): February 3, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Morphine; Levobupivacaine
• Other Study ID Numbers: 20995/2014ps

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No