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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 : Completed
First Posted : April 2, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Serdar Yeşiltaş, Bezmialem Vakif University

Tracking Information
First Submitted Date  ICMJE March 31, 2019
First Posted Date  ICMJE April 2, 2019
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE March 6, 2019
Actual Primary Completion Date September 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2019)
Pain intensity score [ Time Frame: 24 hour ]
Self reported pain intensity in the postoperative 0, 1,2,6,12 and 24 hour. Each item is scored 0-10 (0: no pain 10: pain as bad as can be)
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
Pain intensity score [ Time Frame: 1 day ]
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)
Change History Complete list of historical versions of study NCT03899545 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • Postoperative opioid consumption [ Time Frame: 1 day ]
    If pain intensity score >4 morphine will be given to the patient. The total amount of morphine given will be recorded.
  • Postoperative nausea and vomiting [ Time Frame: 1 day ]
    Nausea and vomiting intensity score measured by numeric rank score
  • Patient satisfaction: score [ Time Frame: 1 day ]
    Will be scored between 1-5 (1- very bad 5-very good).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Serratus Plane Plus Pectoral I Block Versus Serratus Plane Block for Perioperative Analgesia in Breast Cancer Surgery
Official Title  ICMJE Does Serratus Plane Plus Pectoral I Block Provide Better Perioperative Analgesia in Ambulatory Breast Cancer Surgery When Compared to Serratus Plane Block Alone
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).
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, 1,2, 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Postoperative Pain
  • Postoperative Nausea
  • Patient Satisfaction
  • Narcotic Use
Intervention  ICMJE
  • Other: Serratus Plane Block
    0.5 ml /kg Bupivacaine/lidocaine mixture will be injected onto the serratus muscle
  • 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.
Study Arms  ICMJE
  • Experimental: Serratus Plane Block
    Serratus plane block will be applied after induction of general anesthesia.
    Intervention: Other: Serratus Plane Block
  • Active Comparator: Serratus Plane Block plus Pectoral I block
    Serratus plane plus pectoral I block will be applied after induction of general anesthesia.
    Intervention: Other: Serratus Plane Block plus Pectoral I Block
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 20, 2019
Actual Primary Completion Date September 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03899545
Other Study ID Numbers  ICMJE 71306642-5/24
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Serdar Yeşiltaş, Bezmialem Vakif University
Study Sponsor  ICMJE Bezmialem Vakif University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Serdar Yeşiltaş, MD Bezmialem Vakif University
PRS Account Bezmialem Vakif University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP