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Combined PECS II and Transversus Plane Blocks Versus Erector Spinae Block in Modified Radical Mastectomy

Primary Purpose

Breast Cancer, Acute Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Combined Modified Pectoralis and Transversus Plane Blocks
Erector Spinae block
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast Cancer, Regional Anaesthesia, Morphine Consumption

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18: 60 years old
  • ASA (American Society of Anesthesiologists) physical status I II
  • Female patients scheduled for modified radical mastectomy

Exclusion Criteria:

  • Patient refusal or inability to give informed consent
  • Subjects with a medical contraindication to regional anesthesia , such as coagulopathy, local infection or an allergy to local anesthetic
  • Body mass index (BMI) >35
  • Presence of psychiatric diseases
  • History of chronic chest wall pain or neuropathic disorders
  • Alcohol or drug abuse
  • Severe chest wall deformities

Sites / Locations

  • Assiut University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Combined PECS II and TTP blocks (PT)

Erector Spinae Block (E)

Arm Description

Modified Pectoralis block (PECS II) : Using ultrasound we proceed to inject 10 ml of bupivacaine 0.25% between the pectoral muscles and 10 ml under Pmm above the serratus muscle. Transversus Thoracic Plane block : 10 mL bupivacaine (0.25%) is injected between the transversus thoracic muscle and the internal intercostal muscle between the third and fourth left ribs connecting at the sternum.

Using ultrasound an echogenic 22-G block needle is inserted in-plane in a cranial-to-caudal direction until contact is made with the T5 transverse process. A total of 30 bupivacaine 0.25% is then injected while seeing the fluid lifting the erector spinae muscle off.

Outcomes

Primary Outcome Measures

The total morphine consumption postoperative (mg)
Morphine consumption in mg

Secondary Outcome Measures

Postoperative pain score by Verbal numeric rating scale
Verbal numeric rating scale (VNRS) for postoperative pain monitoring using 11-point where zero equals no pain and 10 equals the worst pain imaginable.
Time to first request analgesia postoperative (min)
Time from postoperative period to time of first analgesic request in minutes
Postoperative level of IL6 (interleukin 6) (pg/mL)
Preoperative baseline and postoperative levels of IL6 will be measured (pg/mL)
Arterial blood gas: Arterial blood gas: Arterial blood gases
Oxygen (mmHg) and carbon dioxide (mmHg)

Full Information

First Posted
March 29, 2019
Last Updated
February 17, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03903224
Brief Title
Combined PECS II and Transversus Plane Blocks Versus Erector Spinae Block in Modified Radical Mastectomy
Official Title
Effect of Combined Modified Pectoralis and Transversus Plane Blocks Versus Erector Spinae Block on Postoperative Analgesia Following Modified Radical Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The aim of this study is to compare the total morphine consumption in the first 24 hour postoperative between combined modified pectoralis block (PECS II) and transversus plane block versus erector spinae block in modified radical mastectomy.
Detailed Description
Breast cancer is the most common malignancy in women in the United States and is second only to lung cancer as a cause of cancer death. Breast surgery is commonly performed as a part of the management of breast cancer, is associated with considerable acute postoperative pain. Ultrasound guided Regional anesthesia is recommended to be a part of multimodal analgesia in order to manage the acute post-operative pain. New techniques are proposed to give adequate control of postoperative analgesia with less opioid needs in the first day postoperative. They include pectoralis nerve modified pectoralis, and erector spinae blocks. The investigators will compare Modified pectoralis nerve block (Pecs II) plus transversus thoracic muscle plane (TTP) block versus Erector spinae block on morphine consumption during first 24 h following modified radical mastectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Acute Postoperative Pain
Keywords
Breast Cancer, Regional Anaesthesia, Morphine Consumption

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined PECS II and TTP blocks (PT)
Arm Type
Active Comparator
Arm Description
Modified Pectoralis block (PECS II) : Using ultrasound we proceed to inject 10 ml of bupivacaine 0.25% between the pectoral muscles and 10 ml under Pmm above the serratus muscle. Transversus Thoracic Plane block : 10 mL bupivacaine (0.25%) is injected between the transversus thoracic muscle and the internal intercostal muscle between the third and fourth left ribs connecting at the sternum.
Arm Title
Erector Spinae Block (E)
Arm Type
Active Comparator
Arm Description
Using ultrasound an echogenic 22-G block needle is inserted in-plane in a cranial-to-caudal direction until contact is made with the T5 transverse process. A total of 30 bupivacaine 0.25% is then injected while seeing the fluid lifting the erector spinae muscle off.
Intervention Type
Procedure
Intervention Name(s)
Combined Modified Pectoralis and Transversus Plane Blocks
Other Intervention Name(s)
PECS II and TTP
Intervention Description
Modified pectoralis nerve block (Pecs II) aims to block at least the pectoral nerves, the intercostobrachial, intercostals III-IV-V-VI. This will cover dermatomes T2, T3 and T4. The probe is positioned under the lateral third of the clavicle .After locating the subclavian muscle, the axillary artery and the axillary vein we move the probe distally towards the axilla, until the pectoralis minor is identified. We start counting the ribs , from r1 under the axillary artery, we move distally and laterally until the lateral border of pectoralis minor is reached. The serratus anterior muscle which covers r2, r3, r4 is the point of entrance into the axilla. Blocking of multiple anterior branches of intercostal nerves (Th2-6) using a transversus thoracic muscle plane (TTP) block is used as an additive to pecs II to cover the internal mammary region
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae block
Intervention Description
The patient is placed in a sitting position and The T5 spinous process is located by palpating and counting down from the C7 spinous process. Under complete aseptic conditions a linear ultrasound probe is then placed in a transverse orientation at the level of the T5 transverse process. The tip of the transverse process is centred on the ultrasound screen and the probe is then rotated into a longitudinal orientation to produce a parasagittal view. From T1 to T5 the erector spinae, rhomboid major and trapezius muscles are visible posterior and superficial to the transverse processes.
Primary Outcome Measure Information:
Title
The total morphine consumption postoperative (mg)
Description
Morphine consumption in mg
Time Frame
The first 24 hours postoperative.
Secondary Outcome Measure Information:
Title
Postoperative pain score by Verbal numeric rating scale
Description
Verbal numeric rating scale (VNRS) for postoperative pain monitoring using 11-point where zero equals no pain and 10 equals the worst pain imaginable.
Time Frame
0, 2, 4, 8, 12, 24 hours postoperatively.
Title
Time to first request analgesia postoperative (min)
Description
Time from postoperative period to time of first analgesic request in minutes
Time Frame
The first 24 hours postoperatively
Title
Postoperative level of IL6 (interleukin 6) (pg/mL)
Description
Preoperative baseline and postoperative levels of IL6 will be measured (pg/mL)
Time Frame
Two blood samples will be withdrawn from the patient. The first one is immediately preoperative and the second one after 24 hours postoperative
Title
Arterial blood gas: Arterial blood gas: Arterial blood gases
Description
Oxygen (mmHg) and carbon dioxide (mmHg)
Time Frame
Before surgery and 24 hours postoperative.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18: 60 years old ASA (American Society of Anesthesiologists) physical status I II Female patients scheduled for modified radical mastectomy Exclusion Criteria: Patient refusal or inability to give informed consent Subjects with a medical contraindication to regional anesthesia , such as coagulopathy, local infection or an allergy to local anesthetic Body mass index (BMI) >35 Presence of psychiatric diseases History of chronic chest wall pain or neuropathic disorders Alcohol or drug abuse Severe chest wall deformities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelrahman H Mohammed, A Lecturer
Phone
01060989574
Ext
+2
Email
abdelrahmanhm89@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed H Bakri, Professor
Phone
01066356375
Ext
+2
Email
mhbakri@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman A Ismail, A Lectuer
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman A Ismail, Lecturer
Phone
+201060223750
Email
emanismail97@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
29980005
Citation
Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
Results Reference
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Combined PECS II and Transversus Plane Blocks Versus Erector Spinae Block in Modified Radical Mastectomy

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