Postoperative Pain Clinical Trial
Official title:
Comparative Study of Bupivacaine Versus Bupivacaine-Dexmedetomidine in Ultrasound Guided Serratus Plane Block for Patients Undergoing Modified Radical Mastectomy
Verified date | October 2018 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | October 8, 2018 |
Est. primary completion date | October 8, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Oncology Center Mansoura University. | Mansourah | DKH |
Lead Sponsor | Collaborator |
---|---|
Alaa Mazy |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The time of the first analgesia request | minutes | 24 hours postoperative | |
Secondary | The total analgesic requirements (Ketorolac) | milligram | 24 hours postoperative | |
Secondary | Pain assessed by Visual Analogue Scale | Visual Analogue Scale: between 0 and 10 (0 representing no pain and 10 is the worst imaginable pain) | Postoperative: immediately after surgery, 2, 4, 6,10, 16, 24 hours postoperative | |
Secondary | Amount of fentanyl consumption | microgram | Intraoperative. | |
Secondary | Mean arterial blood pressure | millimeter mercury | intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours | |
Secondary | Heat rate | Beat per minute | intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours | |
Secondary | 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. |
postoperative:10, 20, 30 minutes after extubation | |
Secondary | The Incidence of postoperative nausea and vomiting | percent | postoperative for 24 hours | |
Secondary | Patient satisfaction assessed by a visual analogue score | A score (0-10): 0 is the least satisfaction,10 the maximum satisfaction. | postoperative 24 hours after surgery |
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