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

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

Official title:

A Randomized Controlled Study Comparing Thoracic Paravertebral Block to Serratus Anterior Plane Block in Breast Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453086
• Other study ID #: N19-2016/MD
• Status: Completed
• Phase: N/A
• First received: December 29, 2017
• Last updated: March 14, 2018
• Start date: January 4, 2018
• Est. completion date: February 12, 2018

Study information

• Verified date: March 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

•The blocks techniques:

• Group I: Thoracic paravertebral block group (TPVB group n=15) These patients will receive single ipsilateral ultrasound-guided thoracic paravertebral block. TPVB will be performed with the patient in the sitting position at the level of the 4th thoracic vertebra under complete aseptic precaution with the probe in a vertical position approximately 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. Both transverse processes should be visualized, with the superior costo-transverse ligament and the pleura visible in between .An 18-20 gauge 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. the investigators will inject small aliquots of normal saline intermittently as the investigators advance the needle to confirm the position of the tip. When the needle tip is located immediately above the pleura, the needle is aspirated to confirm the absence of blood or air. After this, 15-20 cc of bupivacaine 0.25% will be injected. Spread of local anaesthetic with depression of the pleura will be clearly visualized. The extent of local anaesthetic spread should be evaluated by moving the ultrasound probe superiorly and inferiorly.

• Group II :Serratus anterior plane block group (SAP group n= 15) These patients will receive serratus anterior plane block. The SAP block will be performed while the patient is in the supine position by using a linear US 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 ultrasound overlying the fifth rib. The needle (Stimuplex, B Braun, Germany 22-G, 50-mm) will be introduced in-plane with respect to the ultrasound probe from supero-anterior to postero-inferior. Under continuous ultrasound guidance, the investigators will inject 20 cc of bupivacaine 0.25%. The sensory level will be tested with pin prick and ice pack before induction of general anesthesia

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 12, 2018
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Female patients

2. Breast surgery with or without axillary clearance.

3. Age from 20 to 60 years.

4. ASA I, II, III.

Exclusion Criteria:

1. Major reconstructive breast surgery.

2. Age younger than 20 or older than 60 years.

3. ASA IV, V.

4. Hypersensitivity to any drug to be used.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Thoracic paravertebral block(TPVB) group
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

Locations

Country	Name	City	State
Egypt	Ahmed Abdalla Mohamed	Cairo
Egypt	Kasr Alainy Hospitals	Cairo

Sponsors (5)

Lead Sponsor	Collaborator
Cairo University	Ahmed Abdalla Mohamed, Ahmed Zaghloul Fouad, Laila Halim Doss, Michael Zarif Sobhy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First pain medication request	Time to the first pain medication request till application of the block	24 hours
Secondary	Time of pain onset	Time of onset of Pain	24 hours
Secondary	Hemodynamics (heart rate)	Hemodynamics in the form of heart rate "beats per minute"	24 hours
Secondary	Hemodynamics (ABP)	Hemodynamics in the form of arterial blood pressure" mm Hg".	24 hours
Secondary	Nausea and vomiting	Postoperative nausea and vomiting	24 hours