Clinical trial NCT03498092: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: The time of the first analgesia request
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: The total analgesic requirements (Ketorolac)
timeFrame: 24 hours postoperative
measure: Pain assessed by Visual Analogue Scale
timeFrame: Postoperative: immediately after surgery, 2, 4, 6,10, 16, 24 hours postoperative
measure: Amount of fentanyl consumption
timeFrame: Intraoperative.
measure: Mean arterial blood pressure
timeFrame: intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours
measure: Heat rate
timeFrame: intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours
measure: Sedation assessed by the observer's assessment of alertness & sedation score
timeFrame: postoperative:10, 20, 30 minutes after extubation
measure: The Incidence of postoperative nausea and vomiting
timeFrame: postoperative for 24 hours
measure: Patient satisfaction assessed by a visual analogue score
timeFrame: postoperative 24 hours after surgery
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Oncology Center Mansoura University.
state: DKH
Study officials:
References: