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

Primary Purpose

Postoperative Pain, Analgesia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasound guided bi-level erector spinae plane block
Ultrasound guided modified pectoral nerve block
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Pain focused on measuring Regional anaesthesia, Erector spinae plane block, PECs blocks, Breast cancer surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists Classification (ASA) I-II patients
  • 18-70 aged patients
  • patients who scheuled elective breast cancer surgery

Exclusion Criteria:

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

Sites / Locations

  • Kocaeli University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bi-level erector spinae plane block

Modified pectoral nerve block

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 27, 2020
Last Updated
June 28, 2021
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT04689581
Brief Title
Comparison of Bi-level Erector Spine Plane Block and Combined Pectoral I-II Block in Breast Surgery
Official Title
Comparison of Postoperative Efficacy of Ultrasound-guided Bi-level Erector Spine Plane Block and Combined Pectoral I-II Block in Breast Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 10, 2021 (Actual)
Study Completion Date
January 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
After being informed about the study and potential risks, written consent was obtained from all patients. Patients who meet eligibility requirements will be randomized in a 1:1 ratio to bi- level erector spinae plane block and modified pectoral block.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Analgesia
Keywords
Regional anaesthesia, Erector spinae plane block, PECs blocks, Breast cancer surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bi-level erector spinae plane block
Arm Type
Experimental
Arm Description
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.
Arm Title
Modified pectoral nerve block
Arm Type
Experimental
Arm Description
Ultrasound (US)-guided modified pectoral nerve block (PECs) with 30 ml 0.25% bupivacaine will performe preoperatively to all patients in the PECs group.
Intervention Type
Other
Intervention Name(s)
Ultrasound guided bi-level erector spinae plane block
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Ultrasound guided modified pectoral nerve block
Intervention Description
Ultrasound (US)-guided modified pectoral nerve block (PECs) with 30 ml 0.25% bupivacaine will performe preoperatively to all patients in the PECs group.
Primary Outcome Measure Information:
Title
Morphin consumption
Description
Patients in both groups will provide with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia.
Time Frame
during postoperative 24 hour
Title
numerical rating scale (NRS)
Description
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
Time Frame
during postoperative 24 hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists Classification (ASA) I-II patients 18-70 aged patients patients who scheuled elective breast cancer surgery Exclusion Criteria: American Society of Anesthesiologists Classification (ASA) III-IV patients patients with coagulopathy patients with infection at the injection site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevim Cesur, MD
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University
City
Kocaeli
Country
Turkey

12. IPD Sharing Statement

Links:
URL
http://pubmed.ncbi.nlm.nih.gov/32609389/
Description
Efficacy of erector spinae plane block for analgesia in breast surgery: a systematic review and meta-analysis

Learn more about this trial

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

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