CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Serratus Anterior Plane Block +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05201963
NCT05201963N/ACompleted

Effect of Ultrasound Guided Erector Spinae Plane Block Versus Ultrasound Guided Serratus Anterior Block on the Incidence of Post Mastectomy Pain Syndrome, Randomized Double Blinded Controlled Study

National Cancer Institute, Egypt·interventional·Posted Jan 21, 2022·Updated Oct 1, 2024

In Brief

A clinical study evaluating Serratus Anterior Plane Block and Erector Spinae Plane Block for Breast Cancer and 2 related conditions. Completed, enrolled 120 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 21, 2022
Enrollment StartNov 1, 2021
Primary CompletionMay 30, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 4.4 years ago

Interventions

Serratus Anterior Plane Blockprocedure

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).

Erector Spinae Plane Blockprocedure

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