Clinical trial

Erector Spinae Plane Block in Different Volumes on Postoperative Pain Control Following Breast Surgery: A Randomized, Prospective Study

NCT05232084

Name

Medipol Hospital 26

Description

Postoperative pain is an important issue in female patients underwent breast surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay. The US-guided erector spina plane block (ESPB) may be used for postoperative pain treatment following breast surgery. It is a relatively novel interfascial block that was defined by Forero et al. It has been reported that ESPB provides effective analgesia management for several breast surgeries.

Trial arms

Trial start

2022-01-27

Estimated PCD

2023-05-20

Trial end

2023-05-25

Status

Completed

Treatment

Bupivacaine + Fentanyl

Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.

Arms:

Group 20 = 20 ml of Erector spinae plane block group, Group 30 = 30 ml of Erector spinae plane block group

Size

Primary endpoint

Postoperative opioid consumption (need and demand as microgram)

Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.

Eligibility criteria

Inclusion Criteria: * American Society of Anesthesiologists (ASA) classification I-II * Scheduled for mastectomy and axillary dissection surgery under general anesthesia Exclusion Criteria: * anticoagulant treatment, * known local anesthetic allergy, * infected skin around the block site, * pregnancy or breast-feeding, * back abnormalities

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are two models for this study. The first group is 30 ml volume ESPB group. The second one is 20 ml volume ESPB group', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The participant and the anesthesiologist who will perform postoperative pain evaluation and opioid consumption will not know the group', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

Updated at

2023-05-30

1 organization

1 product

3 indications

Organization

Medipol University

Product

Bupivacaine + Fentanyl

Indication

Breast Cancer

Indication

Breast Neoplasms

Indication

Breast Diseases