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OpenTrials
Completed

NCT Number: NCT02677571

PVB vs 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.

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Key information

Conditions

Reconstruction Breast Surgery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera Istituti Ospitalieri di Cremona

Cremona, CR, 26100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paravertebral Thoracic block

Procedure

Pectorals nerve block

Procedure

Levobupivacaine 0.25%

Drug

Morphine

Drug

Primary outcomes

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

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. Numerical Rating Scores for pain at rest and during movement

    Time frame: 24 hours postoperatively

  2. Postoperative nausea/vomiting incidence

    Time frame: 24 hours postoperatively

  3. Time of performance

    Time frame: During procedure execution

  4. Propofol consumption in intraoperative period

    Time frame: Intraoperative period

    Propofol consumption in intraoperative period to maintain total intravenous general anesthesia (BIS target 40-60). Propofol consumption in mg/kg/h

  5. Opioids (remifentanyl) consumption in intraoperative period

    Time frame: 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

  6. Numerical Rating Scores during procedure execution

    Time frame: During procedure execution

Sponsors and collaborators

Lead sponsor

Istituti Ospitalieri di Cremona

Other

Registry information

Official study title

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

Acronym: PVBvsPECS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 9, 2016
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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