NCT02645474

Brief Summary

Two regional anesthesia techniques already in use in common clinical practice -paravertebral block and pectoral nerve block (PECS block) are compared in a randomized, double-blind, multicenter, controlled, non-inferiority trial, in order to compare their success rate in patients udergoing breast surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2018

Longer than P75 for phase_4

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

First Submitted

Initial submission to the registry

December 29, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
2 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

6 years

First QC Date

December 29, 2015

Last Update Submit

August 5, 2024

Conditions

Other Acute Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Success rate (measured via visual analogue scale)

    Changes in postoperative pain level of intensity over time will be measured via visual analogue scale (on a 0 to 100 scale, where 0 means no pain and 100 stands for the maximum pain ever experienced). Patients in both groups will be asked to rate their postoperative pain levels at fixed intervals, i.e. in the postoperative anesthesia care unit and once in the ward at 6, 12, 24 hours after surgery

    24 hours after surgery

Secondary Outcomes (2)

  • Safety (incidence of complications)

    24 hours after surgery

  • Patients' satisfaction (subjective perception of the experience on a 0 to 100 scale)

    24 hours after surgery

Study Arms (2)

Paravertebral block with ropivacaine

ACTIVE COMPARATOR

Patients are treated with an older technique (paravertebral block with ropivacaine), somehow established in treating pain after breast surgery. This technique has been shown to be effective but has an intrinsic risk of iatrogenic pneumothorax and is considered technically demanding.

Procedure: Paravertebral block with ropivacaineDrug: Ropivacaine

PECS block with ropivacaine

EXPERIMENTAL

Patients are treated with PECS block, which has been already adopted in common clinical practice as an alternative to paravertebral block for postoperative pain treatment after breast surgery. This technique is thought to be somehow simpler to perform and safer with regard to pneumothorax, however no studies have been done yet to statistically compare the two blocks with regard to safety and effectiveness.

Procedure: PECS block with ropivacaineDrug: Ropivacaine

Interventions

PECS block with ropivacainePROCEDURE

Local anesthetic (ropivacaine 0.5%, total volume 30 ml) is infiltrated in between the fasciae of serratus and minor pectoralis muscles under ultrasound guidance.

Also known as: Pectoral muscles sheath block
PECS block with ropivacaine
Paravertebral block with ropivacainePROCEDURE

Local anesthetic (ropivacaine 0.5%, total volume 20 ml) is infiltrated in the paravertebral block at T4 level under ultrasound guidance.

Also known as: PVB
Paravertebral block with ropivacaine
RopivacaineDRUG

Amidic local anesthetic standardly used for nerve block and infiltration

Also known as: Naropine
PECS block with ropivacaineParavertebral block with ropivacaine

Eligibility Criteria

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

You may qualify if:

  • adult patients
  • ASA class 1 to 3 patients
  • patients scheduled for elective breast mastectomy or quadrantectomy

You may not qualify if:

  • patients' refusal
  • contraindication to regional anaesthesia (coagulopathies, concurrent anticoagulant therapy, allergy to local anaesthetics, infection at puncture site)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Regionale di Bellinzona e Valli

Bellinzona, 6500, Switzerland

Location

Related Publications (1)

  • Dossi R, Tasciotti E, van Sander K, Maino P, Reyes Lozano V, Saporito A, Koetsier E. Comparison of Pectoral Nerve and Paravertebral Blocks for Postoperative Pain Management in Breast Surgery: A Multicentre Randomised Double-Blind Trial. J Breast Cancer. 2025 Aug;28(4):268-279. doi: 10.4048/jbc.2025.0060.

    PMID: 40887728DERIVED

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Luciano Anselmi, MD

    Ospedale Regionale di Bellinzona e Valli

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Andrea Saporito MD

Study Record Dates

First Submitted

December 29, 2015

First Posted

January 1, 2016

Study Start

January 1, 2018

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)