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Dexmedetomidine in Serratus Plane Block for Mastectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03498092
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Alaa Mazy, Mansoura University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Bupivacaine-Dexmedetomidine Drug: Bupivacaine Drug: General anesthesia Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparative Study of Bupivacaine Versus Bupivacaine-Dexmedetomidine in Ultrasound Guided Serratus Plane Block for Patients Undergoing Modified Radical Mastectomy
Actual Study Start Date : August 8, 2016
Actual Primary Completion Date : October 8, 2018
Actual Study Completion Date : October 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Experimental: Bupivacaine-Dexmedetomidine group
After general anesthesia, patients will receive a cocktail of isobaric bupivacaine 2.5 mg/ml plus 5 micrograms (mcg)/ml adrenaline and 1mcg/kg dexmedetomidine in a volume of 0.5 ml/kg injected superficial to serratus muscle between and below latissimus dorsi muscle.
Drug: Bupivacaine-Dexmedetomidine
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

Active Comparator: Bupivacaine group
After general anesthesia, patients will receive a cocktail of isobaric bupivacaine 2.5 mg/ml plus 5 micrograms (mcg)/ml adrenaline in a volume of 0.5 ml/kg injected superficial to serratus muscle between and below latissimus dorsi muscle.
Drug: Bupivacaine
isobaric bupivacaine 2.5 mg/ml plus 5 micro gram/ml adrenaline in a volume of 0.5 ml/kg

Placebo Comparator: Saline group
This group will serve as a control and blinding group and will receive saline infiltration in the same manner.
Drug: General anesthesia
Normal saline in a volume of 0.5 ml/kg




Primary Outcome Measures :
  1. The time of the first analgesia request [ Time Frame: 24 hours postoperative ]
    minutes


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female patients scheduled for unilateral modified radical mastectomy.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498092


Locations
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Egypt
Oncology Center Mansoura University.
Mansourah, DKH, Egypt, 35516
Sponsors and Collaborators
Alaa Mazy

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Responsible Party: Alaa Mazy, associate professor of anesthesia and surgical intensive care, Mansoura University
ClinicalTrials.gov Identifier: NCT03498092    
Other Study ID Numbers: MD/16.06.08
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Epinephrine
Racepinephrine
Dexmedetomidine
Anesthetics
Bupivacaine
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents