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Completed

NCT Number: NCT03453086

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

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

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Key information

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Abdalla Mohamed, Cairo, Egypt

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About this study

•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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Other names: Serratus anterior plane block( SAP) group

Primary outcomes

  1. First pain medication request

    Time frame: 24 hours

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

Secondary outcomes

  1. Time of pain onset

    Time frame: 24 hours

    Time of onset of Pain

  2. Hemodynamics (heart rate)

    Time frame: 24 hours

    Hemodynamics in the form of heart rate "beats per minute"

  3. Hemodynamics (ABP)

    Time frame: 24 hours

    Hemodynamics in the form of arterial blood pressure" mm Hg".

  4. Nausea and vomiting

    Time frame: 24 hours

    Postoperative nausea and vomiting

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Ahmed Zaghloul Fouad
  • Laila Halim Doss
  • Michael Zarif Sobhy
  • Mohamed, Ahmed A., M.D.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 5, 2018
Registry last updated
Mar 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.