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Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block for Mastectomy

Primary Purpose

Breast Cancer Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Plane block
Sponsored by
Suez Canal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer Postoperative Pain

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female patient age 20 to 65
  • ASA I, II
  • Scheduled for mastectomy

Exclusion Criteria:

  • Allergy to local anaesthetics
  • Infection at the site of performing the block
  • Morbidly obese patient of body mass index more than 40 kg/m2

Sites / Locations

  • Suez Canal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Serratus anterior plane block

Erector spinae plane block

Arm Description

Serratus anterior plane block was performed in the supine position placing the ipsilateral upper limb in abduction 90 degrees position. Aiming to find the serratus anterior muscle the investigator identified the fifth rib in the mid-axillary line by the linear probe in the sagittal plane. The latissimus dorsi muscle (superficial and posterior), teres major muscle (superior) and serratus muscles (deep and inferior) were detected using ultrasound. The investigator penetrated the serratus anterior muscle by a 25 GA, 90 mm spinal needle in-plane concerning the ultrasound probe from superoanterior to posteroinferior to inject deep to it.

Erector spinae plane block was performed at lateral decubitus with the operation site up, the vertebrae were counted from cephalad to caudal direction until reaching T5 spinous process as the first palpable spinous process is C7. The ultrasound probe was placed vertically 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The needle was introduced from superior to inferior direction in-plane until the tip lay deep to erector spinae muscle.

Outcomes

Primary Outcome Measures

First time analgesia request
The first time the patient ask for analgesia to control postoperative pain

Secondary Outcome Measures

Total analgesic consumption
The total calculated analgesics that were administered to control post operative pain
visual analogue scale
A subjective method to measure pain, where 0=no pain and 10 = worst comprehensible pain

Full Information

First Posted
May 1, 2020
Last Updated
September 28, 2022
Sponsor
Suez Canal University
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1. Study Identification

Unique Protocol Identification Number
NCT04372862
Brief Title
Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block for Mastectomy
Official Title
Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block to Control Postmastectomy Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
In this study, we are comparing two different techniques of plane blocks to control postoperative mastectomy pain serratus anterior plane block and erector spinae plane block, both are done with ultrasonic guidance We are recording the first time of analgesia request postoperatively as a primary outcome

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective comparative randomized clinical trial
Masking
ParticipantCare ProviderInvestigator
Masking Description
double-blinded
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Serratus anterior plane block
Arm Type
Active Comparator
Arm Description
Serratus anterior plane block was performed in the supine position placing the ipsilateral upper limb in abduction 90 degrees position. Aiming to find the serratus anterior muscle the investigator identified the fifth rib in the mid-axillary line by the linear probe in the sagittal plane. The latissimus dorsi muscle (superficial and posterior), teres major muscle (superior) and serratus muscles (deep and inferior) were detected using ultrasound. The investigator penetrated the serratus anterior muscle by a 25 GA, 90 mm spinal needle in-plane concerning the ultrasound probe from superoanterior to posteroinferior to inject deep to it.
Arm Title
Erector spinae plane block
Arm Type
Active Comparator
Arm Description
Erector spinae plane block was performed at lateral decubitus with the operation site up, the vertebrae were counted from cephalad to caudal direction until reaching T5 spinous process as the first palpable spinous process is C7. The ultrasound probe was placed vertically 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The needle was introduced from superior to inferior direction in-plane until the tip lay deep to erector spinae muscle.
Intervention Type
Procedure
Intervention Name(s)
Plane block
Other Intervention Name(s)
Block
Intervention Description
Two different plane blocks to control post-mastectomy pain
Primary Outcome Measure Information:
Title
First time analgesia request
Description
The first time the patient ask for analgesia to control postoperative pain
Time Frame
Postoperative up to 24 hours
Secondary Outcome Measure Information:
Title
Total analgesic consumption
Description
The total calculated analgesics that were administered to control post operative pain
Time Frame
Postoperative up to 24 hours
Title
visual analogue scale
Description
A subjective method to measure pain, where 0=no pain and 10 = worst comprehensible pain
Time Frame
Every two hours for 24 hours postoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients of breast cancer operated for mastectomy
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patient age 20 to 65 ASA I, II Scheduled for mastectomy Exclusion Criteria: Allergy to local anaesthetics Infection at the site of performing the block Morbidly obese patient of body mass index more than 40 kg/m2
Facility Information:
Facility Name
Suez Canal University
City
Ismailia
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block for Mastectomy

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