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Clinical Trials/NCT03453086
NCT03453086
Completed
Not Applicable

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

Cairo University2 sites in 1 country30 target enrollmentJanuary 4, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Comparison of Thoracic Paravertebral Block to Serratus Anterior Plane Block in Breast Surgery
Sponsor
Cairo University
Enrollment
30
Locations
2
Primary Endpoint
First pain medication request
Status
Completed
Last Updated
8 years ago

Overview

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

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

Registry
clinicaltrials.gov
Start Date
January 4, 2018
End Date
February 12, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Abdalla

Assistant Professor of Anesthesia &I.C.U and Pain Clinic

Cairo University

Eligibility Criteria

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.
  • Hypersensitivity to any drug to be used.

Outcomes

Primary Outcomes

First pain medication request

Time Frame: 24 hours

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

Secondary Outcomes

  • Hemodynamics (ABP)(24 hours)
  • Time of pain onset(24 hours)
  • Hemodynamics (heart rate)(24 hours)
  • Nausea and vomiting(24 hours)

Study Sites (2)

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