PVB vs PECS Block in Breast Surgery (PVBvsPECS)

Istituti Ospitalieri di Cremona

Status: Completed

Conditions: Reconstruction Breast Surgery

Treatments: Drug: Morphine; Procedure: Paravertebral Thoracic block; Procedure: Pectorals nerve block; Drug: Levobupivacaine 0.25%

Study type: Interventional

Funder types: Other

Identifiers

NCT02677571

20995/2014ps

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

55 participants in 2 patient groups

PVB

Experimental group

Description:

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

Treatment:

Procedure: Paravertebral Thoracic block

Drug: Morphine

Drug: Levobupivacaine 0.25%

PECS

Experimental group

Description:

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

Treatment:

Procedure: Pectorals nerve block

Drug: Morphine

Drug: Levobupivacaine 0.25%