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Pectoral Nerve Block and Erector Spine Plane Block in Breast Cancer Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135157
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
CENGİZ KAYA (ckaya)
Information provided by (Responsible Party):
Caner Genç, Ondokuz Mayıs University

Brief Summary:
This study evaluates the analgesic effects of Pectoralis nerve block and Erector spina plane block in patients having mastectomy and sentinel lymph node dissection. Each one-third of patients will have erector spine block and pectoralis nerve block 30 min before general anesthesia , while other one-third of patients will have only general anesthesia.

Condition or disease Intervention/treatment Phase
Anesthesia Analgesia Acute Pain Chronic Pain Pectoralis Nerve Block Erector Spine Plane Block Patient Controlled Analgesia Procedure: Pectoralis nerve block Procedure: Erector spine plane block Other: Control Not Applicable

Detailed Description:

It has been proven that pectoralis nerve block (PECs) and erector spine plane block (ESP) both supply effective analgesia in the first 24 hours after mastectomy. But they do so by different mechanishms.

This study is to survey that ESP and PECs may supply acute and chronic analgesia by reducing pain scores in the first 24 hours and 3 months after the surgery, also the comparison of the analgesic activity among themselves for acute and chronic pain will be searched.

In this study patients are divided into three groups. Group A - Patients in group A will have COMBIPECs block (PECs2 -> PECs1) in a separate section from the operating rooms (PNB practice room). In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.

Group B - Patients in group B will have ESP block in a separate section from the operating rooms (PNB practice room). In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.

Group C - Patients in group C will not be performed planar nerve block. Only general anesthesia (GA) will be performed in the operation room. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer generated randomization codes.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The anesthesia doctor who will perform the peripheral nerve block (PNB) will be informed with a sealed envelope by an independent assistant outside the study, and the patient will not know which block is performed.
Primary Purpose: Supportive Care
Official Title: Research of the Effects of Pectoralis Nerve Blocks and Erector Spina Plan Block on Post-operative Acute and Chronic Pain in Breast Cancer Surgery
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: PECs & ESP
Pectoralis nerve block and erector spine plane block are performed 30 minutes before general anesthesia. Patient controlled analgesia device (PCA) is used for all the patients in the first 24 hours postoperatively.
Procedure: Pectoralis nerve block
Pecs block will be performed 30 min. before general anesthesia.
Other Name: PECs

Procedure: Erector spine plane block
ESP block will be performed 30 minutes before general anesthesia.
Other Name: ESP

Active Comparator: Control
In the control group, patients will have only general anesthesia. Patient controlled analgesia device (PCA) is used for all the patients in the first 24 hours postoperatively.
Other: Control
Only general anesthesia will be performed.




Primary Outcome Measures :
  1. Post-operative acute pain [ Time Frame: 1 day ]
    Pain status will be evaluated based on VAS scores in two different positions: arm at rest and arm in abduction. Pain status will be evaluated at 1-3-6-12-24. hours after surgery. Each VAS is scores 0-10. (0=no pain ; 10=pain as bad as can be)

  2. Post-operative chronic pain [ Time Frame: 3. month after surgery ]
    Pain status will be evaluated in the third month after surgery based on VAS scores in two different positions: arm at rest and arm in abduction. Each VAS is scores 0-10. (0=no pain ; 10=pain as bad as can be)


Secondary Outcome Measures :
  1. Opioid consumption in the first 24 hours after surgery [ Time Frame: 1 day ]
    Morphine consumption in the first 24 hours will be counted by IV PCA. Patients will be able to request opioids via PCA device when the vas score is above 4 when the arm is in the resting position.

  2. Remifentanil consuption during the surgery [ Time Frame: During the surgery ]
    Following induction of general anesthesia, anesthesia maintenance will be continued with sevoflurane to BIS 40-50 (bispectral index). When the BIS is between 40-50, remifentanil infusion rate will be changed considering ± 20% changes in blood pressure compared to baseline values.The total amount of remifentanil consumed will be recorded.

  3. Post-operative nausea and vomiting (PONV) [ Time Frame: 1 day ]
    The patients will be evaluated according to the five-stage verbal descriptive PONV scale. If it is 3 points or more, ondansetron 4 mg IV will be administered. Wait for 8 hours for the next dose of ondansetron. (0 = None, 1 = Slight nausea, 2 = Moderate nausea, 3 = Once vomiting, 4 = vomiting more than one)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women with breast cancer having mastectomy and axillary lymph node dissection
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA 1-2 patients between the age of 18-65, scheduled for elective unilateral mastectomy + sentinal lymph disection

Exclusion Criteria:

  • Age <18 or> 65, ASA 3-4 patients
  • Obesity (> 100 kg, BMI> 35 kg / m2)
  • Patients undergoing bilateral mastectomy
  • Pregnancy
  • Contraindication of regional anesthesia (quagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
  • Serious renal, cardiac, hepatic disease
  • Hypersensitivity to local anesthetics or a history of allergy
  • Patients with a history of opioid use longer than four weeks
  • Patients with psychiatric disorders
  • Patients with chest deformity
  • Patients with previous breast surgery except diagnostic biopsies
  • Patients who do not want to participate

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): NCT04135157


Contacts
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Contact: CANER GENÇ, MD 05444846865 ext +9 caner.genc@omu.edu.tr
Contact: GÖKÇE ŞENOCAK, MD 05449771624 ext +9 ngokcesenocak@gmail.com

Locations
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Turkey
Ondokuz Mayıs University Faculty of Medicine Recruiting
Samsun, Turkey, 55270
Contact: Sezen Akgürel    05432498536 ext +9    sezener@omu.edu.tr   
Sponsors and Collaborators
Ondokuz Mayıs University
CENGİZ KAYA (ckaya)
Investigators
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Study Director: CENGİZ KAYA, MD Ondokuz Mayıs University Faculty of Medicine
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Responsible Party: Caner Genç, Medical Doctor, Ondokuz Mayıs University
ClinicalTrials.gov Identifier: NCT04135157    
Other Study ID Numbers: PA191001001
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Caner Genç, Ondokuz Mayıs University:
Regional Anesthesia
Acute and chronical pain
Pectoralis nerve block
Erector spine plane block
Additional relevant MeSH terms:
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Chronic Pain
Acute Pain
Neurologic Manifestations
Signs and Symptoms
Pain