Erector Spinae Plane Block Versus Serratus Anterior Block on Post Mastectomy Pain Syndrome
NCT05201963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2024-10-01
Summary
Breast cancer is the most common malignancy among females. Nearly 40-60% of breast surgery patients experience severe acute postoperative pain, with severe pain persisting for 6-12 months in almost 20-50% of patients (post mastectomy pain syndrome) which is defined according to International Association for the Study of Pain (IASP) as pain which persists more than 3 months after mastectomy/lumpectomy affecting the anterior thorax, axilla, and/or medial upper arm. Regionale anesthesia is one of the strategies with the potential to prevent the development of chronic pain following breast surgery. We hypothesize that erector spinae plane block is going to be more effective than serratus anterior plane block in the prevention of postmastectomy pain syndrome.
Conditions
- Breast Cancer
- Post-mastectomy Pain Syndrome
- Acute Pain
Interventions
- PROCEDURE
-
Serratus Anterior Plane Block
Full aseptic precautions applied. Ultrasound probe will be placed on the patient's midaxillary line in the longitudinal plane (lateral position with arm abduction), at the level of 5th rib, the indicator oriented toward the operator's left. With the rib, pleural line, overlying serratus anterior and latissimus dorsi muscles visualized, then, a 38-mm 22-gauge regional block needle will be advanced in-plane at an angle of approximately 45 degrees towards the 5th rib. After aspiration to avoid intravascular injection 30ml of levobupivacaine 0.25% will be injected anteriorly to the rib and deep to the serratus anterior muscle. The entirety of the needle should be visualized at all times throughout the procedure.6-13-MHz, linear transducer set for small parts and a depth of 1-4 cm is used for this block(15-16).
- PROCEDURE
-
Erector Spinae Plane Block
Full aseptic precautions applied. Ultrasound probe will be placed on the back in a transverse orientation to identify the tip of the T5 transverse process. The tip of the transverse process will be centered on the ultrasound screen and the probe will then be rotated into a longitudinal orientation to produce a parasagittal view, in which skin, subcutaneous tissue, trapezius and erector spinae muscle will be visible superficial to T5 transverse process. Echogenic block needle will be inserted in- plane to the ultrasound beam in a cranial-to-caudal direction until contact is made with the T5 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle will be confirmed by injecting 0.5-1 ml normal saline . After aspiration to avoid intravascular injection 30 ml levobupivacaine 0.25% will be performed. 6-13-MHz, linear transducer set for small parts and a depth of 4-6 cm will be used
Sponsors & Collaborators
-
National Cancer Institute, Egypt
lead OTHER
Principal Investigators
-
Mohammed Magdy, Master · National Cancer Institute Cairo University
-
Somaya Elsheikh Abdelaziz, Professor · National Cancer Institute Cairo University
-
Ahmed H. Bekir, Professor · National Cancer Institute Cairo University
-
Sayed M. Abed, Lecturer · National Cancer Institute Cairo University
-
Mohammed ElSaed Abdelfattah, Lecturer · National Cancer Institute Cairo University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-01
- Primary Completion
- 2024-05-30
- Completion
- 2024-05-30
Countries
- Egypt
Study Locations
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