Comparison of Bi-level Erector Spine Plane Block and Combined Pectoral I-II Block in Breast Surgery

NCT04689581 | Completed

• 1 other identifier: KOU KAEK 2018/487
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, we compared ultrasound-guided modified pectoral nerve (PECS) block and bi level erector spinae plane (ESP) block on postoperative analgesic effect in breast surgery.

Conditions

Postoperative Pain; Analgesia

Keywords

Regional anaesthesia; Erector spinae plane block; PECs blocks; Breast cancer surgery

Outcome Measures

Primary Outcomes (2)

• Morphin consumption

  Patients in both groups will provide with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia.

  during postoperative 24 hour

• numerical rating scale (NRS)

  A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable

  during postoperative 24 hour

Study Arms (2)

Bi-level erector spinae plane block

EXPERIMENTAL

Bi-level ultrasound (US)-guided Erector spinae plane block (ESP) with 30 ml 0.25% bupivacaine at the T2 andT4 vertebral level will performe preoperatively to all patients in the ESP group.

Other: Ultrasound guided bi-level erector spinae plane block

Modified pectoral nerve block

EXPERIMENTAL

Ultrasound (US)-guided modified pectoral nerve block (PECs) with 30 ml 0.25% bupivacaine will performe preoperatively to all patients in the PECs group.

Other: Ultrasound guided modified pectoral nerve block

Interventions

Ultrasound guided bi-level erector spinae plane block OTHER

Bi-level ultrasound (US)-guided Erector spinae plane block (ESP) with 30 ml 0.25% bupivacaine at the T2 andT4 vertebral level will performe preoperatively to all patients in the ESP group.

Bi-level erector spinae plane block

Ultrasound guided modified pectoral nerve block OTHER

Ultrasound (US)-guided modified pectoral nerve block (PECs) with 30 ml 0.25% bupivacaine will performe preoperatively to all patients in the PECs group.

Modified pectoral nerve block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists Classification (ASA) I-II patients
• aged patients
• patients who scheuled elective breast cancer surgery

You may not qualify if:

• American Society of Anesthesiologists Classification (ASA) III-IV patients
• patients with coagulopathy
• patients with infection at the injection site

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Related Links

• Efficacy of erector spinae plane block for analgesia in breast surgery: a systematic review and meta-analysis

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Sevim Cesur, MD

  Kocaeli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: December 27, 2020
• First Posted: December 30, 2020
• Study Start: January 1, 2020
• Primary Completion: January 10, 2021
• Study Completion: January 15, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

TU (1)