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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03903224
Enrollment
60
Registered
2019-04-04
Start date
2021-02-08
Completion date
2023-11-01
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Postoperative Pain, Breast Cancer

Keywords

Breast Cancer, Regional Anaesthesia, Morphine Consumption

Brief 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.

Detailed 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.

Interventions

PROCEDURECombined 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

PROCEDUREErector 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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The total morphine consumption postoperative (mg)The first 24 hours postoperative.Morphine consumption in mg

Secondary

MeasureTime frameDescription
Postoperative pain score by Verbal numeric rating scale0, 2, 4, 8, 12, 24 hours postoperatively.Verbal numeric rating scale (VNRS) for postoperative pain monitoring using 11-point where zero equals no pain and 10 equals the worst pain imaginable.
Time to first request analgesia postoperative (min)The first 24 hours postoperativelyTime from postoperative period to time of first analgesic request in minutes
Postoperative level of IL6 (interleukin 6) (pg/mL)Two blood samples will be withdrawn from the patient. The first one is immediately preoperative and the second one after 24 hours postoperativePreoperative baseline and postoperative levels of IL6 will be measured (pg/mL)
Arterial blood gas: Arterial blood gas: Arterial blood gasesBefore surgery and 24 hours postoperative.Oxygen (mmHg) and carbon dioxide (mmHg)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026