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

NCT04372862 | Completed

• 1 other identifier: ASPB vs ESBP for mastectomy
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• First time analgesia request

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

  Postoperative up to 24 hours

Secondary Outcomes (2)

• Total analgesic consumption

  Postoperative up to 24 hours

• visual analogue scale

  Every two hours for 24 hours postoperative

Study Arms (2)

Serratus anterior plane block

ACTIVE COMPARATOR

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.

Procedure: Plane block

Erector spinae plane block

ACTIVE COMPARATOR

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.

Procedure: Plane block

Interventions

Plane block PROCEDURE

Two different plane blocks to control post-mastectomy pain

Also known as: Block

Erector spinae plane block; Serratus anterior plane block

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: Female patients of breast cancer operated for mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and intensive care

Model Details: prospective comparative randomized clinical trial

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 4, 2020
• Study Start: October 1, 2019
• Primary Completion: May 30, 2020
• Study Completion: July 30, 2020
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)