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CompletedNCT03453086Updated Mar 16, 2018

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

An interventional study of Thoracic paravertebral block(TPVB) group in Comparison of Thoracic Paravertebral Block to Serratus Anterior Plane Block in Breast Surgery, sponsored by Cairo University. Completed at 2 sites in Egypt. Open to female participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-16.

Sponsored by Cairo University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
Female
01

Study 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

Read the detailed 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
02

Conditions studied

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

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03

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Group I:

    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

  • Active comparator
    Group II :

    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

  • ProcedureThoracic 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

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

05

What researchers measure

Primary outcomes

  1. First pain medication request

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

    Time frame: 24 hours

Secondary outcomes

  1. Time of pain onset

    Time of onset of Pain

    Time frame: 24 hours

  2. Hemodynamics (heart rate)

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

    Time frame: 24 hours

  3. Hemodynamics (ABP)

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

    Time frame: 24 hours

  4. Nausea and vomiting

    Postoperative nausea and vomiting

    Time frame: 24 hours

06

Study locations

2 sites
  • Ahmed Abdalla Mohamed
    Cairo, 11451, Egypt
  • Kasr Alainy Hospitals
    Cairo, 11451, Egypt
07

References and documents

Individual participant data

Plan to share: No — Via scholar Gate

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03453086
Lead sponsor
Cairo University
Collaborators
Mohamed, Ahmed A., M.D., Laila Halim Doss, Ahmed Zaghloul Fouad, Michael Zarif Sobhy
Responsible party
Ahmed Abdalla (Assistant Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University) — Principal investigator
First posted
Mar 5, 2018
Start date
Jan 4, 2018
Primary completion
Feb 8, 2018
Completion
Feb 12, 2018
Last update
Mar 16, 2018

Study contacts

Ahmed Abdalla, M.D
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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