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New regional anesthesia technique can be better than local anesthetic infiltration at surgical site in patients undergoing breast cancer surgical removal

Erector Spinae Block Produces Better Postoperative Analgesia and Prevents Chronic Pain in Patients Undergoing Mastectomy Associated With Axillary Limphadenectomy? Prospective Randomized Study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-48b9cz
Enrollment
Unknown
Registered
2020-02-12
Start date
2019-01-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Breast Cancer

Interventions

Intervention: application of erector spinal block guided by ultrasound with 20ml ropivacaine 0.75% in 50 patients under general anesthesia who will undergo unilateral mastectomy and axillary lymphaden
Procedure/surgery

Sponsors

AC Camargo Cancer Center
Lead Sponsor
AC Camargo Cancer Center
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients older than 18 years; female; to be submitted to mastectomy with lymphadenectomy and unilateral breastl reconstruction (prosthesis or expander); described surgeries taking place at AC Camargo Cancer Center; no history of allergy to any medication used in the study; absence of contraindication to the regional block (coagulopathy and / or local infection); acceptance to participate in the study.

Exclusion criteria

Exclusion criteria: Patients who require a new surgery within 6 months after mastectomy; patients to whom we cannot contact in periods of 3 and 6 months post surgery; patients who require radiotherapy treatment; patients in which occur block failure.

Design outcomes

Primary

MeasureTime frame
Lower morphine consumption among patients exposed to the block when compared to those not exposed, through total morphine consumed in the hours after surgery. • Average morphine consumption between exposed cases: 1%. • Average morphine consumption among unexposed cases: 1.5%. • Significance level: 5%. • Test power: 95%. • Sample size calculated for each group: 46 In order to evaluate a possible difference in the pain intensity between the anesthetic techniques used, the Mann-Whitney U test will be applied. Analysis will be performed using SPSS software version 23 and software R version 3.4

Secondary

MeasureTime frame
Secondary outcomes are not expected.

Countries

Brazil

Contacts

Public ContactEduardo Sakai

AC Camargo Cancer Center

esakai@gmail.com+5511973182989

Outcome results

None listed

Source: REBEC (via WHO ICTRP)