The analgesic efficacy of Erector Spinae Plane Block, a novel locoregional anesthesia technique in breast cancer surgery

The effect of erector spinae block on postoperative pain and opioid use in patients undergoing breast cancer surgery with sentinel node dissection

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000709-18-NL

Enrollment

Registered

2017-04-12

Start date

2018-07-02

Completion date

Unknown

Last updated

2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing unilateral (modified) mastectomy with sentinel node dissection for breast cancer

Interventions

Trade Name: Ropivacaine HCl Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - >18 years old - ASA I-III - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Allergy or contra-indication for paracetamol or etoricoxib - Chronic opioid use - Known hypersensitivity or contraindication for local anesthetics - Bleeding or infection at the puncture site - Contraindications for regional anesthesia - Any other reason which in the opinion of the investigator makes the patient unsuitable for participation in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to compare analgesic efficacy of standard care with Eerector spinae plane block – as an adjuvant to general anesthesia - in breast cancer surgery patients undergoing unilateral (modified) mastectomy with sentinel node dissection;Secondary Objective: - Time to perform procedure - Patient discomfort during procedure - Extend of sensory block - Patient satisfaction with post-operative analgesia - Incidence of side-effects and complications (including, but not limited to: hypotension, nausea and vomiting, infection/ bleeding at puncture site, allergic reaction...);Primary end point(s): Main study parameter is postoperative opioid use and postoperative pain score. ;Timepoint(s) of evaluation of this end point: 24 hours after placement of erector spinae plane block	—

Measure

Time frame

Main Objective: The aim of this study is to compare analgesic efficacy of standard care with Eerector spinae plane block – as an adjuvant to general anesthesia - in breast cancer surgery patients undergoing unilateral (modified) mastectomy with sentinel node dissection;Secondary Objective: - Time to perform procedure - Patient discomfort during procedure - Extend of sensory block - Patient satisfaction with post-operative analgesia - Incidence of side-effects and complications (including, but not limited to: hypotension, nausea and vomiting, infection/ bleeding at puncture site, allergic reaction...);Primary end point(s): Main study parameter is postoperative opioid use and postoperative pain score. ;Timepoint(s) of evaluation of this end point: 24 hours after placement of erector spinae plane block

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Secondary

Measure	Time frame
Secondary end point(s): - Time to perform procedure in minutes by the anaesthesiologist placing the ESPB. - Patient satisfaction with post-operative analgesia (NRS score asked 24 hours after surgery, 0 = very dissatisfied, 10 = very satisfied) - Patient discomfort during placement of the ESPB (NRS score, 0 = very uncomfortable, 10 = absolutely comfortable) - Incidence of side-effects and complications (including, but not limited to: hypotension, nausea and vomiting, infection/ bleeding at puncture site, allergic reaction...). ;Timepoint(s) of evaluation of this end point: 24 hours after placement of erector spinae plane block	—

Measure

Time frame

Secondary end point(s): - Time to perform procedure in minutes by the anaesthesiologist placing the ESPB. - Patient satisfaction with post-operative analgesia (NRS score asked 24 hours after surgery, 0 = very dissatisfied, 10 = very satisfied) - Patient discomfort during placement of the ESPB (NRS score, 0 = very uncomfortable, 10 = absolutely comfortable) - Incidence of side-effects and complications (including, but not limited to: hypotension, nausea and vomiting, infection/ bleeding at puncture site, allergic reaction...). ;Timepoint(s) of evaluation of this end point: 24 hours after placement of erector spinae plane block

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Countries

Netherlands

Contacts

Public ContactClinical Trial Bureau

Bernhoven

m.fenten@bernhoven.nl+31413401382

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026