Serratus Plane Plus Pectoral I Block Versus Serratus Plane Block for Perioperative Analgesia in Breast Cancer Surgery
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|ClinicalTrials.gov Identifier: NCT03899545|
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : August 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain Postoperative Nausea Patient Satisfaction Narcotic Use||Other: Serratus Plane Block Other: Serratus Plane Block plus Pectoral I Block||Not Applicable|
In breast surgeries, the serratus plane block has recently been described and rapidly became popular. The serratus plane block is called the modified pectoral II block. Local anesthetic drugs are injected onto the serratus muscle by targeting thoracodorsal nerve, thoracicus longus nerve, lateral and anterior branches of the T2-T9 intercostal nerves. In the pectoral I (Pecs I) block, the medial and lateral pectoral nerves of the brachial plexus are targeted. Additionally, Pecs I block can be effective for analgesia in axillary dissection. In the literature, there are studies comparing pectoral I + II blocks and serratus plane block in terms of analgesic efficacy in breast surgery. The aim of this study was to evaluate the postoperative analgesic efficiency of serratus plane block and serratus plan block plus pectoral I block combination.
Participans will be informed about the potential benefits and complications after the study protocol has been fully and thoroughly explained. After premedication with 0.03 mg / kg iv midazolam, participans will be noninvasively monitored by taking into the operating room (heart rate, blood pressure, pulse oximetry). Anesthesia induction will delivered with fentanyl 1mcg / kg, propofol 1.5-2 mg / kg and rocuronium 0.5 mg / kg. The maintenance of anesthesia will be achieved by infusion of sevoflurane 1-3% in 50% O2/50% medical air. The depth of anesthesia will be evaluated with bispectral index monitoring and will be kept between 40 and 60.. Thirty minutes before end of the surgery, all patients were intravenously administered 20 mg tenoxicam HCl and 1gr paracetamol.
SPB plus Pecs I block technique: Bupivacaine/lidocaine mixture will be injected onto the serratus muscle and injected between the pectoralis minor/pectoralis major muscles.
SPB technique: Bupivacaine/lidocaine mixture will be injected onto the serratus muscle.
After the surgery, 1 g paracetamol was intravenously administered once every 8 h. Postoperative pain was assessed using VAS (VAS 0 = no pain, VAS 10 = most severe pain ). Morphine 0.1mg / kg will be used as rescue analgesic drug.Duration at PACU was recorded right from 0 h. VAS scores at 0, 1, 6, 12 and 24 h were recorded. PONV was evaluated using a numeric ranking scale (0 = no PONV, 1 = mild nausea, 2 = severe nausea or vomiting once attack, and 3 = vomiting more than once attack). If PONV score was >2, the antiemetic metoclopramide Hcl 10mg was intravenously administered.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Does Serratus Plane Plus Pectoral I Block Provide Better Perioperative Analgesia in Ambulatory Breast Cancer Surgery When Compared to Serratus Plane Block Alone|
|Actual Study Start Date :||March 6, 2019|
|Estimated Primary Completion Date :||September 5, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Experimental: Serratus Plane Block
Serratus plane block will be applied after induction of general anesthesia.
Other: Serratus Plane Block
0.5 ml /kg Bupivacaine/lidocaine mixture will be injected onto the serratus muscle
Active Comparator: Serratus Plane Block plus Pectoral I block
Serratus plane plus pectoral I block will be applied after induction of general anesthesia.
Other: Serratus Plane Block plus Pectoral I Block
0.5 ml / kg %0.25 Bupivacaine/ %1 lidocaine mixture will be injected onto the serratus muscle and injected between the pectoralis minor/pectoralis major muscles.2/3 of the total drug will be applied for the serratus plane block and 1/3 of the total drug for the pectoral I block. If the total amount of the drug is less than 30 ml, it will be completed with isotonic saline to 30 ml.
- Pain intensity score [ Time Frame: 24 hour ]Self reported pain intensity in the postoperative 1,2,6,12 and 24 hour. Each item is scored 0-10 (0: no pain 10: pain as bad as can be)
- İntraoperative fentanyl requirement [ Time Frame: during surgery ]Total amount of fentanyl use
- time to first analgesic request [ Time Frame: 24 hour ]time to first analgesic use
- Postoperative opioid consumption [ Time Frame: 24 hour ]If pain intensity score >4 morphine 0,1 mg/kg will be given to the patient. The total amount of morphine requirement will be recorded.
- Postoperative nausea and vomiting [ Time Frame: 24 hour ]Nausea and vomiting intensity score measured by numeric rank score (0:no nausea and no vomiting, 1: have nausea, no vomiting, 2: once vomiting, 3: two or more vomiting).
- Patient satisfaction: score [ Time Frame: 24 hour ]Will be scored between 1-5 (1- very bad 5-very good).
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): NCT03899545
|Contact: Serdar Yeşiltaş||+90 542 363 26 email@example.com|
|Bezmialem Vakıf University||Recruiting|
|Istanbul, Turkey, 34093|
|Contact: Serdar Yeşiltaş +90 542 363 26 30 firstname.lastname@example.org|
|Principal Investigator:||Serdar Yeşiltaş, MD||Bezmialem Vakif University|