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Dexmedetomidine in Serratus Plane Block for Mastectomy

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine-Dexmedetomidine
Bupivacaine
General anesthesia
Sponsored by
Alaa Mazy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Oncology Center Mansoura University.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Bupivacaine-Dexmedetomidine group

Bupivacaine group

Saline group

Arm Description

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.

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.

This group will serve as a control and blinding group and will receive saline infiltration in the same manner.

Outcomes

Primary Outcome Measures

The time of the first analgesia request
minutes

Secondary Outcome Measures

The total analgesic requirements (Ketorolac)
milligram
Pain assessed by Visual Analogue Scale
Visual Analogue Scale: between 0 and 10 (0 representing no pain and 10 is the worst imaginable pain)
Amount of fentanyl consumption
microgram
Mean arterial blood pressure
millimeter mercury
Heat rate
Beat per minute
Sedation assessed by the observer's assessment of alertness & sedation score
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.
The Incidence of postoperative nausea and vomiting
percent
Patient satisfaction assessed by a visual analogue score
A score (0-10): 0 is the least satisfaction,10 the maximum satisfaction.

Full Information

First Posted
April 2, 2018
Last Updated
October 20, 2018
Sponsor
Alaa Mazy
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1. Study Identification

Unique Protocol Identification Number
NCT03498092
Brief Title
Dexmedetomidine in Serratus Plane Block for Mastectomy
Official Title
Comparative Study of Bupivacaine Versus Bupivacaine-Dexmedetomidine in Ultrasound Guided Serratus Plane Block for Patients Undergoing Modified Radical Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 8, 2016 (Actual)
Primary Completion Date
October 8, 2018 (Actual)
Study Completion Date
October 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alaa Mazy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine-Dexmedetomidine group
Arm Type
Experimental
Arm Description
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.
Arm Title
Bupivacaine group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Saline group
Arm Type
Placebo Comparator
Arm Description
This group will serve as a control and blinding group and will receive saline infiltration in the same manner.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-Dexmedetomidine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
isobaric bupivacaine 2.5 mg/ml plus 5 micro gram/ml adrenaline in a volume of 0.5 ml/kg
Intervention Type
Drug
Intervention Name(s)
General anesthesia
Intervention Description
Normal saline in a volume of 0.5 ml/kg
Primary Outcome Measure Information:
Title
The time of the first analgesia request
Description
minutes
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
The total analgesic requirements (Ketorolac)
Description
milligram
Time Frame
24 hours postoperative
Title
Pain assessed by Visual Analogue Scale
Description
Visual Analogue Scale: between 0 and 10 (0 representing no pain and 10 is the worst imaginable pain)
Time Frame
Postoperative: immediately after surgery, 2, 4, 6,10, 16, 24 hours postoperative
Title
Amount of fentanyl consumption
Description
microgram
Time Frame
Intraoperative.
Title
Mean arterial blood pressure
Description
millimeter mercury
Time Frame
intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours
Title
Heat rate
Description
Beat per minute
Time Frame
intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours
Title
Sedation assessed by the observer's assessment of alertness & sedation score
Description
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.
Time Frame
postoperative:10, 20, 30 minutes after extubation
Title
The Incidence of postoperative nausea and vomiting
Description
percent
Time Frame
postoperative for 24 hours
Title
Patient satisfaction assessed by a visual analogue score
Description
A score (0-10): 0 is the least satisfaction,10 the maximum satisfaction.
Time Frame
postoperative 24 hours after surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female patients scheduled for unilateral modified radical mastectomy.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Oncology Center Mansoura University.
City
Mansourah
State/Province
DKH
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

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Dexmedetomidine in Serratus Plane Block for Mastectomy

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