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Completed

NCT Number: NCT03498092

Dexmedetomidine in Serratus Plane Block for Mastectomy

The serratus plane block (SPB) described by Blanco et al, 2013 is a progression from the work with the Pecs I and II blocks. The serratus muscle is a superficial and easily identified muscle and considered a true landmark to perform thoracic wall blocks because lateral cutaneous branches of the intercostal nerves pierce it in the mid-axillary line. A local anesthetic (LA) is injected under ultrasound (US) guidance either superficial or deep to serratus anterior muscle providing predictable and relatively long-lasting regional anesthesia, which would be suitable for surgical procedures performed on the chest wall.

The linear US probe of frequency (6-13 MHz) is placed over the mid-clavicular region in a sagittal plane.The ribs are counted inferiorly and laterally until the fifth rib in the midaxillary line is identified.The latissimus dorsi, teres major, and serratus muscles are identified.

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Key information

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oncology Center Mansoura University.

Al Mansurah, DKH, 35516, Egypt

About this study

Possible regional techniques for breast surgery include selective intercostal nerve blockade, thoracic paravertebral blockade, thoracic epidural, intrapleural, local wound infiltration. Each of these techniques has advantages and disadvantages. In general, local or wound infiltration is safe but limited in terms of duration of action, depending on the local anesthetic (LA) used. More invasive techniques such as selective intercostal nerve blocks and thoracic paravertebral blockade may be complicated by pneumothorax or transient Horner's syndrome These techniques are also may be associated with higher risk of local anesthetic toxicity. Besides the neurological side-effects associated with thoracic epidural and paravertebral blocks such as post-sympathectomy hypotension and bradycardia, total spinal block, paraplegia, epidural hematoma, unpredictable spread, intravascular injection also requires special skill precluding their routine use in the setting of day-case surgery. With the use of ultrasound (US) devices in anesthetic practice, newer regional techniques based on detailed knowledge of innervations of the breast are developed as the pectoral nerve (Pecs) block I and II.The breast innervations briefly include lateral and medial pectoral nerves that arise from the brachial plexus innervating the pectoral muscles.The anterior divisions of the thoracic intercostal nerves from T2 to T6. They give off lateral and anterior branches. The Lateral branches pierce the external intercostalis and the serratus anterior muscles at the mid-axillary line to give off anterior and posterior terminal cutaneous branches. The lateral cutaneous branch of the second intercostal nerve does not divide and it is called the intercostobrachial nerve.The Anterior branches pierce the internal intercostalis muscle, the intercostal membranes, and pectoralis major to supply the breast in its medial aspect.The long thoracic nerve passes on the serratus anterior muscle supplying it. The thoracodorsal nerve innervates the latissimus dorsi muscle.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients of American Society of Anesthesiologists (ASA) grade I - III.
  • Scheduled for unilateral modified radical mastectomy.

Exclusion criteria

  • Patient with the skin infection in the axilla.
  • Allergy to local anesthetics of the amide type.
  • Patient refusal.

Treatment and study plan

Bupivacaine-Dexmedetomidine

Drug

isobaric bupivacaine 2.5 mg/ml plus 5 micro gram/ml adrenaline and 1 micro gram/kg dexmedetomidine in a volume of 0.5 ml/kg

Bupivacaine

Drug

isobaric bupivacaine 2.5 mg/ml plus 5 micro gram/ml adrenaline in a volume of 0.5 ml/kg

General anesthesia

Drug

Normal saline in a volume of 0.5 ml/kg

Primary outcomes

  1. The time of the first analgesia request

    Time frame: 24 hours postoperative

    minutes

Secondary outcomes

  1. The total analgesic requirements (Ketorolac)

    Time frame: 24 hours postoperative

    milligram

  2. Pain assessed by Visual Analogue Scale

    Time frame: Postoperative: immediately after surgery, 2, 4, 6,10, 16, 24 hours postoperative

    Visual Analogue Scale: between 0 and 10 (0 representing no pain and 10 is the worst imaginable pain)

  3. Amount of fentanyl consumption

    Time frame: Intraoperative.

    microgram

  4. Mean arterial blood pressure

    Time frame: intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours

    millimeter mercury

  5. Heat rate

    Time frame: intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours

    Beat per minute

  6. Sedation assessed by the observer's assessment of alertness & sedation score

    Time frame: postoperative:10, 20, 30 minutes after extubation

    sedation score (1-5):

    5 = patient respond to name spoken in normal voice.

    4 = patient asleep but arousable to normal tone voice.

    3 = patient asleep but arousable to loud voice.

    2 = patient asleep but arousable by mild prodding or shaking.

    1 = comatose.

  7. The Incidence of postoperative nausea and vomiting

    Time frame: postoperative for 24 hours

    percent

  8. Patient satisfaction assessed by a visual analogue score

    Time frame: postoperative 24 hours after surgery

    A score (0-10): 0 is the least satisfaction,10 the maximum satisfaction.

Sponsors and collaborators

Lead sponsor

Alaa Mazy

Other

Registry information

Official study title

Comparative Study of Bupivacaine Versus Bupivacaine-Dexmedetomidine in Ultrasound Guided Serratus Plane Block for Patients Undergoing Modified Radical Mastectomy

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 13, 2018
Registry last updated
Oct 23, 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.

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