Dexmedetomidine in Serratus Plane Block for Mastectomy
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|ClinicalTrials.gov Identifier: NCT03498092|
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : October 23, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|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|
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.
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.
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
- The time of the first analgesia request [ Time Frame: 24 hours postoperative ]minutes
- The total analgesic requirements (Ketorolac) [ Time Frame: 24 hours postoperative ]milligram
- 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)
- Amount of fentanyl consumption [ Time Frame: Intraoperative. ]microgram
- Mean arterial blood pressure [ Time Frame: intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours ]millimeter mercury
- Heat rate [ Time Frame: intraoperative every 30 minutes, and postoperative at 2, 4, 6, 10, 16, 24 hours ]Beat per minute
- 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.
- The Incidence of postoperative nausea and vomiting [ Time Frame: postoperative for 24 hours ]percent
- 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.
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
|Oncology Center Mansoura University.|
|Mansourah, DKH, Egypt, 35516|