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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
Sponsor:
Information provided by (Responsible Party):
Serdar Yeşiltaş, Bezmialem Vakif University

Brief Summary:
Breast cancer is the most common malignancy in women at worldwide. Even a minor breast surgery can cause significant postoperative pain (PP) (1). PP could be converted into chronic pain in 25-40% of cases. Inadequate PP control is associated with increased morbidity, delay in wound healing, prolonged hospital stay, increased opioid use, increased side effects and high cost of care. For these reasons, regional anesthetic techniques are recommended for effective PP management. Some of recent studies suggest that ultrasound-guided pectoral I (PI), pectoral II (PII) and serratus plan block (SPB) may be an alternative to thoracic epidural analgesia and paravertebral block applications because of the ease of administration, low side effect profile and adequate analgesia in breast surgery. (2,3).

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

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. İntraoperative fentanyl requirement [ Time Frame: during surgery ]
    Total amount of fentanyl use

  2. time to first analgesic request [ Time Frame: 24 hour ]
    time to first analgesic use

  3. 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.

  4. 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).

  5. Patient satisfaction: score [ Time Frame: 24 hour ]
    Will be scored between 1-5 (1- very bad 5-very good).



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ASA 1-2-3
  2. Patients scheduled for elective surgery

Exclusion Criteria:

  1. Previous neurological disease symptom (TIA, syncope, dementia, etc.)
  2. Allergy to drugs
  3. Major cardiac disease
  4. Renal failure
  5. Psychiatric disease
  6. Patients who refuse to participate in the study

Information from the National Library of Medicine

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


Contacts
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Contact: Serdar Yeşiltaş +90 542 363 26 30 syesiltas@bezmialem.edu.tr

Locations
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Turkey
Bezmialem Vakıf University Recruiting
Istanbul, Turkey, 34093
Contact: Serdar Yeşiltaş    +90 542 363 26 30    syesiltas@bezmialem.edu.tr   
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
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Principal Investigator: Serdar Yeşiltaş, MD Bezmialem Vakif University

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Responsible Party: Serdar Yeşiltaş, Lecturer, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03899545     History of Changes
Other Study ID Numbers: 71306642-5/24
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Serdar Yeşiltaş, Bezmialem Vakif University:
serratus plane block
pectoral I block
breast cancer surgery
perioperative analgesia
Additional relevant MeSH terms:
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Postoperative Nausea and Vomiting
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Nausea
Signs and Symptoms, Digestive
Vomiting