Comparison of Thoracic Paravertebral Block , Pectoral Nerve Block to Serratus Anterior Plane Block in Breast Surgery, A Randomized Controlled Study

NCT03453086 | Completed DMC

• 1 other identifier: N19-2016/MD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators hypothesize that the analgesic efficacy of ultrasound-guided serratus anterior plane block will provide better analgesia with fewer complications in comparison to ultrasound guided thoracic paravertebral block

Conditions

Comparison of Thoracic Paravertebral Block to Serratus Anterior Plane Block in Breast Surgery

Outcome Measures

Primary Outcomes (1)

• First pain medication request

  Time to the first pain medication request till application of the block

  24 hours

Secondary Outcomes (4)

• Time of pain onset

  24 hours

• Hemodynamics (heart rate)

  24 hours

• Hemodynamics (ABP)

  24 hours

• Nausea and vomiting

  24 hours

Study Arms (2)

Group I:

ACTIVE COMPARATOR

These patients will receive single ipsilateral Ultrasound TPVB which performed with the patient in the sitting position at the level of the T4 with the probe in a vertical position 2.5-3 cm lateral to the midline. The midpoint of the transducer is to be placed in a longitudinal paramedian plane between two transverse processes which visualized with the superior costo-transverse ligament and the pleura visible in between . After this, 15-20 cc of bupivacaine 0.25% will be injected

Procedure: Thoracic paravertebral block(TPVB) group

Group II :

ACTIVE COMPARATOR

These patients will receive serratus anterior plane block. The block will be performed while the patient is in the supine position by using a linear Ultrasound probe of high frequency (6-13 MHz) after sheathing. The probe will be placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The ribs will be counted inferiorly and laterally, until the 5th rib is identified in the midaxillary line. The latissimus dorsi (superficial and posterior) , teres major (superior) and serratus muscles (deep and inferior) will be then easily identifiable by U/S overlying the fifth rib.

Procedure: Thoracic paravertebral block(TPVB) group

Interventions

Thoracic paravertebral block(TPVB) group PROCEDURE

Thoracic paravertebral block group (TPVB) group: The midpoint of the transducer is to be placed in a longitudinal paramedian plane between two transverse processes.Tuohy needle will be introduced in a cephalad direction. The tip of the needle will be advanced under direct visualization until it pierces the superior costo-transverse ligament. When the needle tip is located immediately above the pleura, the needle is aspirated to confirm the absence of blood or air. Serratus anterior plane block group (SAP) group: The US probe will be placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The ribs will be counted until the 5th rib is identified in the midaxillary line. The latissimus dorsi, teres major and serratus muscles will be then easily identifiable by US overlying the fifth rib. The needle will be introduced in-plane with respect to the US probe from supero-anterior to postero-inferior

Also known as: Serratus anterior plane block( SAP) group

Group I:; Group II :

Eligibility Criteria

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

You may qualify if:

• Female patients
• Breast surgery with or without axillary clearance.
• Age from 20 to 60 years.
• ASA I, II, III.

You may not qualify if:

• Major reconstructive breast surgery.
• Age younger than 20 or older than 60 years.
• ASA IV, V.
• Hypersensitivity to any drug to be used.

Sponsors & Collaborators

• Cairo University: lead
• Mohamed, Ahmed A., M.D.: collaborator
• Laila Halim Doss: collaborator
• Ahmed Zaghloul Fouad: collaborator
• Michael Zarif Sobhy: collaborator

Study Sites (2)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

Kasr Alainy Hospitals

Cairo, 11451, Egypt

Location

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Ahmed Abdalla, M.D

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: •Patients will be randomly allocated to one of the two groups by sealed closed envelop technique
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia &I.C.U and Pain Clinic

Model Details: Although thoracic epidural analgesia is the gold standard technique after breast surgery paravertebral block (PVB) has become a potential alternative approach. However, both techniques may be associated with serious complications such as pneumothorax, total spinal anaesthesia and inadvertent intravascular injection. Recently since the advent of ultrasound (US) in anaesthetic practice several interfascial plane blocks have been described. Serratus plane block is a novel interfascial plane block which can provide analgesia after breast surgery. The serratus anterior plane block is an interfascial plane block where the local anaesthetics are injected superficial to serratus anterior at the 5th rib level in the mid axillary line. The serratus plane block is a progression from Blanco's et al work with the Pecs I and II blocks by making the technique easier in its application using single injection and to lower the potential side-effects

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: March 5, 2018
• Study Start: January 4, 2018
• Primary Completion: February 8, 2018
• Study Completion: February 12, 2018
• Last Updated: March 16, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)