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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03903224
Other study ID # Analgesia in breast surgey
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 8, 2021
Est. completion date November 1, 2023

Study information

Verified date February 2024
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Intervention

Procedure:
Combined Modified Pectoralis and Transversus Plane Blocks
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
Erector Spinae block
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.

Locations

Country Name City State
Egypt Assiut University Hospital Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The total morphine consumption postoperative (mg) Morphine consumption in mg The first 24 hours postoperative.
Secondary 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. 0, 2, 4, 8, 12, 24 hours postoperatively.
Secondary Time to first request analgesia postoperative (min) Time from postoperative period to time of first analgesic request in minutes The first 24 hours postoperatively
Secondary Postoperative level of IL6 (interleukin 6) (pg/mL) Preoperative baseline and postoperative levels of IL6 will be measured (pg/mL) Two blood samples will be withdrawn from the patient. The first one is immediately preoperative and the second one after 24 hours postoperative
Secondary Arterial blood gas: Arterial blood gas: Arterial blood gases Oxygen (mmHg) and carbon dioxide (mmHg) Before surgery and 24 hours postoperative.
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