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Dexmedetomidine in Serratus Plane Block for Mastectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03498092
Enrollment
150
Registered
2018-04-13
Start date
2016-08-08
Completion date
2018-10-08
Last updated
2018-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

Interventions

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

DRUGBupivacaine

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

DRUGGeneral anesthesia

Normal saline in a volume of 0.5 ml/kg

Sponsors

Alaa Mazy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The time of the first analgesia request24 hours postoperativeminutes

Secondary

MeasureTime frameDescription
Pain assessed by Visual Analogue ScalePostoperative: immediately after surgery, 2, 4, 6,10, 16, 24 hours postoperativeVisual Analogue Scale: between 0 and 10 (0 representing no pain and 10 is the worst imaginable pain)
Amount of fentanyl consumptionIntraoperative.microgram
Mean arterial blood pressureintraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hoursmillimeter mercury
The total analgesic requirements (Ketorolac)24 hours postoperativemilligram
Sedation assessed by the observer's assessment of alertness & sedation scorepostoperative:10, 20, 30 minutes after extubationsedation 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 vomitingpostoperative for 24 hourspercent
Patient satisfaction assessed by a visual analogue scorepostoperative 24 hours after surgeryA score (0-10): 0 is the least satisfaction,10 the maximum satisfaction.
Heat rateintraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hoursBeat per minute

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026