U/S Guided Transversus Thoracic and Pectoral Nerve Block Versus Pectoral Nerve Block in MRM

NCT06371625 | Completed

• 1 other identifier: AP2202-30104
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

Interfascial blocks score over regional anesthetic techniques such as Transversus Thoracic Plane Block and Pectoral Nerves (PECS) Block as they have no risk of sympathetic blockade, intrathecal or epidural spread, which may lead to hemodynamic instability and prolonged hospital stay. The transversus thoracic muscle plane block (TTP) block is a newly developed regional anesthesia technique which provides analgesia to the anterior chest wall. First described by Ueshima et al. in 2015, the TTP block is a single-shot nerve block that deposits local anesthetic in the transversus thoracic muscle plane between the internal intercostal and transversus thoracic muscles. TTP block targets the anterior branches of the intercostal nerves (T2-6). Pectoral plane blocks are recently described . PECS block involves deposition of local anesthetic drug between muscle planes. PECS I block, between Pectoralis Major and Minor at third rib level, and PECS II block, the drug is deposited between Pectoralis minor and Serratus anterior muscle. The pectoral nerves (PECS) block provides analgesia of the lateral mammary region, the intercostobrachial and lateral cutaneous branches of the intercostal nerves (T2-T6), the medial cutaneous nerve of the arm and forearm, and the long thoracic and thoracodorsal nerves. The modified PECS block produces excellent analgesia and can be used to provide balanced anesthesia.

Conditions

Breast Cancer; Analgesia

Keywords

Breast Neoplasms; Analgesics; Opioids; Postoperative Pain; Mastectomy; Nerve block

Outcome Measures

Primary Outcomes (1)

• total morphine consumption

  total morphine consumption as iv analgesic

  24 hours postoperatively

Secondary Outcomes (4)

• visual analogue scale "VAS score"

  24 hours postoperative

• mean blood pressure

  at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively

• heart rate

  at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively

• first analgesic dose

  at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively

Study Arms (2)

Transeversus Thoracic Plane Block (TTPB) [Group A]:

ACTIVE COMPARATOR

block performed in a supine position before general anesthesia. Linear probe of the ultrasound system will be attached at sagittal plane to the sternum and counted from T2 near the clavicle to T5. Then the linear probe will be rotated by 90° and attached between the forth and the fifth costal cartilages connecting at the sternum near nipple. Then, the transversus thoracic muscle and the internal intercostal muscle will be identified.

Procedure: Transeversus Thoracic Plane Block (TTPB) and Pectoral Nerves (PECS) Block

Pectoral Nerves (PECS) Block [Both Groups] :

ACTIVE COMPARATOR

Positioned supine with the ipsilateral arm abducted and externally rotated. The infra-clavicular and axillary regions will be cleaned with chlorhexidine. The probe will be positioned under the lateral third of the clavicle. After locating the subclavian artery, the axillary artery and the axillary vein we will move the probe distally towards the axilla, until the pectorals major muscle is identified. We will start counting the ribs, from 1st rib under the axillary artery and maintaining the pectorals major as a reference, we will move distally and laterally until the lateral border of pectorals major is reached. Serratus anterior muscle cover 2nd, 3rd, 4th rib, this point being the entrance into the anterior axillary line we will use atraumatic needle with extension line and electrode for nerve stimulator (Stimuplex D).

Procedure: Transeversus Thoracic Plane Block (TTPB) and Pectoral Nerves (PECS) Block; Procedure: Pectoral Nerves (PECS) Block

Interventions

Transeversus Thoracic Plane Block (TTPB) and Pectoral Nerves (PECS) Block PROCEDURE

The TTP block will be performed in a supine position before general anesthesia. First, a high linear probe of the ultrasound system will be attached at sagittal plane to the sternum and counted from T2 near the clavicle to T5. Then the linear probe will be rotated by 90° and attached between the forth and the fifth costal cartilages connecting at the sternum near nipple. Then, the transversus thoracic muscle and the internal intercostal muscle will be identified. A total of 15 mL of 0.25% bupivacaine will be injected into the interfascial plane, between the transversus thoracic muscle and the internal intercostal muscle between the fourth and fifth costal cartilages connecting at the sternum. Pleural downward displacement will be used as an ultrasound endpoint.

Pectoral Nerves (PECS) Block [Both Groups] :; Transeversus Thoracic Plane Block (TTPB) [Group A]:

Pectoral Nerves (PECS) Block PROCEDURE

Patients positioned supine with the ipsilateral arm abducted and externally rotated. The infra-clavicular and axillary regions will be cleaned with chlorhexidine. The skin point of and once the structures are identified with ultrasound, the probe will be positioned under the lateral third of the clavicle. After locating the subclavian artery, the axillary artery and the axillary vein we will move the probe distally towards the axilla, until the pectorals major muscle is identified. We will start counting the ribs, from 1st rib under the axillary artery and maintaining the pectorals major. Serratus anterior muscle cover 2nd, 3rd, 4th rib, this point being the entrance into the anterior axillary line we will use atraumatic needle with extension line and electrode for nerve stimulator (Stimuplex D). We will inject 10ml of 0.25% bupivacaine between the pectorals muscles first, then inject 20ml of 0.25% bupivacaine.

Pectoral Nerves (PECS) Block [Both Groups] :

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female patients.
• type of surgery: MRM
• ASA I, II, III
• BMI \>20 kg/m2 and \<35 kg/m2

You may not qualify if:

• BMI \<20 kg/m2 and \>35 kg/m2
• known sensitivity or contraindication to drugs used
• history of psychological disorders.
• patient refusal
• pregnancy
• contraindication to regional anesthesia e.g. local sepsis, pre-existing peripheral neuropathy and coagulopathy

Sponsors & Collaborators

• Ahmed Mohamed Soliman: lead

Study Sites (3)

National cancer Insititute Cairo university

Cairo, 11796, Egypt

Location

National cancer Insititute

Cairo, 11796, Egypt

Location

Ahmed Mohamed Soliman

Giza, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms; Agnosia; Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patients will be randomly assigned into two equal comparable groups using computer- generated random numbers in opaque closed envelopes, each of which will include 11 per group. Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of anesthesia

Model Details: to determine the analgesic effect of ultrasound guided Transversus Thoracic and Pectoral Nerve Block compared to ultrasound guided Pectoral Nerve Block in patients undergoing modified radical mastectomy regarding the following : 1-Post-operative opioid (morphine) consumption in the 1st 24 hours 2- Postoperative Numeric Pain Rating Scale. 3. Effect on hemodynamics: Mean arterial blood pressure and Heart rate. 4. Intraoperative fentanyl consumption. 5. Duration of analgesic effect

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: April 17, 2024
• Study Start: July 2, 2022
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

EG (3)