Combined PECS II and Transversus Plane Blocks Versus Erector Spinae Block in Modified Radical Mastectomy

Breast Cancer Clinical Trial

Official title:

Effect of Combined Modified Pectoralis and Transversus Plane Blocks Versus Erector Spinae Block on Postoperative Analgesia Following Modified Radical Mastectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03903224
• Other study ID #: Analgesia in breast surgey
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acute Postoperative Pain
• Breast Cancer
• Pain, Postoperative

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.