NCT02677571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

January 23, 2016

Last Update Submit

February 2, 2017

Conditions

Reconstruction Breast Surgery

Outcome Measures

Primary Outcomes (1)

  • PCA morphine consumption in the two groups within the first 24 postoperative hours

    24 hours postoperatively

Secondary Outcomes (6)

  • 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

    Intraoperative period

  • Opioids (remifentanyl) consumption in intraoperative period

    Intraoperative period

  • +1 more secondary outcomes

Study Arms (2)

PVB

EXPERIMENTAL

51 patients receiving US guided homolateral paravertebral thoracic block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).

Procedure: Paravertebral Thoracic blockDrug: Levobupivacaine 0.25%Drug: Morphine

PECS

EXPERIMENTAL

51 patients receiving US guided pectorals nerve block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).

Procedure: Pectorals nerve blockDrug: Levobupivacaine 0.25%Drug: Morphine

Interventions

Paravertebral Thoracic blockPROCEDURE
PVB
Pectorals nerve blockPROCEDURE
PECS
Levobupivacaine 0.25%DRUG
PECSPVB
MorphineDRUG
PECSPVB

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age\> 18 years
  • ASA score I - II - III
  • undergoing elective reconstruction breast surgery
  • signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Istituti Ospitalieri di Cremona

Cremona, CR, 26100, Italy

Location

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Giorgio F Danelli, MD

    Istituti Ospedalieri di Cremona

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Anaesthesia Department, Istituti Ospitalieri, Cremon

Study Record Dates

First Submitted

January 23, 2016

First Posted

February 9, 2016

Study Start

December 1, 2015

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

February 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)