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Efect of Erector Spina Plane Block on Mastectomy

Primary Purpose

Pain, Postoperative, Opioid Use

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
erector spinae block
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain, Postoperative focused on measuring erector spinae plane block, opioid consumption, mastectomy, Analgesia nosiseption index

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

adult female patients ASA 1-3 25-70 years old were included in the study.

Exclusion Criteria:

Severe respiratory and heart disease liver or kidney failure coagulopathy local infection at the injection site spine or chest wall deformity allergy to drugs to be used opioid addiction

Sites / Locations

  • Marmara University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

erector spinae plane block group

non block control group

Arm Description

All patients were monitored with standard monitoring (electrocardiography (ECG), noninvasive blood pressure, peripheral oxygen saturation (SpO2)), bispectral index (BIS, Medtronic, Mineapolis) and ANI (analgesia nociception index) -90-120 min) data were recorded.Group ESPB was applied before general anesthesia by the same anesthesiologist with block experience. In the sitting position, using an ultrasound-guided linear probe (6-13 MHz) on the side to be operated, T3 is marked 3 cm from the lateral of the spinous processes and with the in-plane technique, a 22G block needle (100mm, B-Braun, Germany) in the cranio-caudal direction first After it was observed that the erector spina muscle was separated from the transverse process with -2 ml normal saline, 20 ml 0.5% bupivacaine and 100 mg lidocaine were administered. And the drug was found to spread to the craniocaudal line at the ESP on ultrasound.Postoperative pain of the patients was evaluated using VAS (visual analogue scale).

All patients were monitored with standard monitoring (electrocardiography (ECG), noninvasive blood pressure, peripheral oxygen saturation (SpO2)), bispectral index (BIS, Medtronic, Mineapolis) and ANI (analgesia nociception index) -90-120 min) data were recorded.15 minutes before the end of the surgery, 1 gr paracetamol and 100 mg tramadol were given to the control group. Postoperative pain of the patients was evaluated using VAS (visual analogue scale).

Outcomes

Primary Outcome Measures

intraoperative opioid consumption
measurement with analgesia nosiception index monitor

Secondary Outcome Measures

postoperative changes in vas ( visual analog scor)
recorde postoperative vas changes by anesthesist

Full Information

First Posted
March 27, 2021
Last Updated
June 16, 2021
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04824300
Brief Title
Efect of Erector Spina Plane Block on Mastectomy
Official Title
The Effect of Erector Spina Plane Block on Postoperative Pain and Opiod Consumption After Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
February 23, 2021 (Actual)
Study Completion Date
February 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
After breast cancer surgery, more than 60% of patients experience persistent pain.Although opioids are the main method of use in postoperative pain management, there are side effects such as constipation, sedation, respiratory depression, urinary retention, itching, postoperative nausea and vomiting.Erector spina plane block (ESPB) is a technique used in many surgeries for anesthesia and analgesia.It is frequently preferred by anesthesiologists for postoperative analgesia recently because it is easy to apply and no complications are reported in the literature.ESPB with arms of iliocostalis, longissimus and spinalis, is located parallel to the spine, from the back of the skull to the pelvis.The injected local anesthetic is distributed in many levels in the cranio-caudal direction and blocks the intercostal spinal nerves, causing sensory block.Providing the necessary perioperative analgesia due to the complex innervation of the breast tissue is a big controversy among anesthesiologists.Multimodal analgesia methods with various regional blocks are more preferred.ESPB block is also preferred as another method since it provides both perioperative and postoperative analgesia.In studies conducted on cadavers, it has been shown that local analgesia spreads to the paravertebral area when applied under the Erektor Spina muscle.Technically, compared to the paravertebral block,the ESPB has proven to be more reliable and easier in terms of pleural puncture risk. ANI is a monitoring method used in the evaluation of acute nociception and pain.Analyzes the instantaneous changes in heart rate due to the activation of the parasympathetic nervous system using respiratory sinus arrhythmia.A value between 0-100 is obtained.If parasympathetic modulation is very low, a value of 0 is obtained, if it is high, a value of 100 is obtained.ANI detects the noxious stimulus more specifically and sensitively than heart rate and blood pressure changes. Application of anesthesia and having ANI value between 50-70 in the early postoperative period indicates that analgesia is sufficient,and values <50 are the following 10 minutes.Hemodynamic reactivity (20% increase in heart rate or blood pressure) will occur and the level of analgesia is insufficient,and values> 70 indicate that there is no painful stimulus or that more analgesic drugs are used.
Detailed Description
After breast cancer surgery, more than 60% of patients experience persistent pain (1). Although opioids are the main method of use in postoperative pain management, there are side effects such as constipation, sedation, respiratory depression, urinary retention, itching, postoperative nausea and vomiting (2). Erector spina plane block (ESP) is a technique used in many surgeries for anesthesia and analgesia. It is frequently preferred by anesthesiologists for postoperative analgesia recently because it is easy to apply and no complications are reported in the literature. Erector spina muscle, with arms of iliocostalis, longissimus and spinalis, is located parallel to the spine, from the back of the skull to the pelvis. The injected local anesthetic is distributed in many levels in the cranio-caudal direction and blocks the intercostal spinal nerves, causing sensory block (3). Providing the necessary perioperative analgesia due to the complex innervation of the breast tissue is a big controversy among anesthesiologists. Multimodal analgesia methods with various regional blocks are more preferred. Erector Spina Plane block is also preferred as another method since it provides both perioperative and postoperative analgesia (4). In studies conducted on cadavers, it has been shown that local analgesia spreads to the paravertebral area when applied under the Erektor Spina muscle. Technically, compared to the paravertebral block, the Erektor Spina block has proven to be more reliable and easier in terms of pleural puncture risk (5). ANI is a monitoring method used in the evaluation of acute nociception and pain (Figure 2.1). Analyzes the instantaneous changes in heart rate due to the activation of the parasympathetic nervous system using respiratory sinus arrhythmia. A value between 0-100 is obtained. If parasympathetic modulation (stress level eg presence of pain) is very low, a value of 0 is obtained, if it is high, a value of 100 is obtained (7). ANI detects the noxious stimulus more specifically and sensitively than heart rate and blood pressure changes (6). The "yellow colored value" on the upper right corner of the ANI monitor shows the instantaneous ANI value, while the orange colored one shows the average ANI value in the last 4 minutes. (Figure 2.1). Application of anesthesia and having ANI value between 50-70 in the early postoperative period indicates that analgesia is sufficient, and values <50 are the following 10 minutes. A hemodynamic reactivity (20% increase in heart rate or blood pressure) will occur and the level of analgesia is insufficient, and values> 70 indicate that there is no painful stimulus or that more analgesic drugs are used (6). After breast cancer surgery, more than 60% of patients experience persistent pain (1). Although opioids are the main method of use in postoperative pain management, there are side effects such as constipation, sedation, respiratory depression, urinary retention, itching, postoperative nausea and vomiting (2). Erector spina plane block (ESP) is a technique used in many surgeries for anesthesia and analgesia. It is frequently preferred by anesthesiologists for postoperative analgesia recently because it is easy to apply and no complications are reported in the literature. Erector spina muscle, with arms of iliocostalis, longissimus and spinalis, is located parallel to the spine, from the back of the skull to the pelvis. The injected local anesthetic is distributed in many levels in the cranio-caudal direction and blocks the intercostal spinal nerves, causing sensory block (3). Providing the necessary perioperative analgesia due to the complex innervation of the breast tissue is a big controversy among anesthesiologists. Multimodal analgesia methods with various regional blocks are more preferred. Erector Spina Plane block is also preferred as another method since it provides both perioperative and postoperative analgesia (4). In studies conducted on cadavers, it has been shown that local analgesia spreads to the paravertebral area when applied under the Erektor Spina muscle. Technically, compared to the paravertebral block, the Erektor Spina block has proven to be more reliable and easier in terms of pleural puncture risk (5). ANI is a monitoring method used in the evaluation of acute nociception and pain (Figure 2.1). Analyzes the instantaneous changes in heart rate due to the activation of the parasympathetic nervous system using respiratory sinus arrhythmia. A value between 0-100 is obtained. If parasympathetic modulation (stress level eg presence of pain) is very low, a value of 0 is obtained, if it is high, a value of 100 is obtained (7). ANI detects the noxious stimulus more specifically and sensitively than heart rate and blood pressure changes (6). The "yellow colored value" on the upper right corner of the ANI monitor shows the instantaneous ANI value, while the orange colored one shows the average ANI value in the last 4 minutes. (Figure 2.1). Application of anesthesia and having ANI value between 50-70 in the early postoperative period indicates that analgesia is sufficient, and values <50 are the following 10 minutes. A hemodynamic reactivity (20% increase in heart rate or blood pressure) will occur and the level of analgesia is insufficient, and values> 70 indicate that there is no painful stimulus or that more analgesic drugs are used (6).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Opioid Use
Keywords
erector spinae plane block, opioid consumption, mastectomy, Analgesia nosiseption index

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
erector spinae plane block group
Arm Type
Active Comparator
Arm Description
All patients were monitored with standard monitoring (electrocardiography (ECG), noninvasive blood pressure, peripheral oxygen saturation (SpO2)), bispectral index (BIS, Medtronic, Mineapolis) and ANI (analgesia nociception index) -90-120 min) data were recorded.Group ESPB was applied before general anesthesia by the same anesthesiologist with block experience. In the sitting position, using an ultrasound-guided linear probe (6-13 MHz) on the side to be operated, T3 is marked 3 cm from the lateral of the spinous processes and with the in-plane technique, a 22G block needle (100mm, B-Braun, Germany) in the cranio-caudal direction first After it was observed that the erector spina muscle was separated from the transverse process with -2 ml normal saline, 20 ml 0.5% bupivacaine and 100 mg lidocaine were administered. And the drug was found to spread to the craniocaudal line at the ESP on ultrasound.Postoperative pain of the patients was evaluated using VAS (visual analogue scale).
Arm Title
non block control group
Arm Type
No Intervention
Arm Description
All patients were monitored with standard monitoring (electrocardiography (ECG), noninvasive blood pressure, peripheral oxygen saturation (SpO2)), bispectral index (BIS, Medtronic, Mineapolis) and ANI (analgesia nociception index) -90-120 min) data were recorded.15 minutes before the end of the surgery, 1 gr paracetamol and 100 mg tramadol were given to the control group. Postoperative pain of the patients was evaluated using VAS (visual analogue scale).
Intervention Type
Procedure
Intervention Name(s)
erector spinae block
Intervention Description
Erector spina plane block (ESP) is a technique used in many surgeries for anesthesia and analgesia. It is frequently preferred by anesthesiologists for postoperative analgesia recently because it is easy to apply and no complications are reported in the literature. Erector spina muscle, with arms of iliocostalis, longissimus and spinalis, is located parallel to the spine, from the back of the skull to the pelvis. The injected local anesthetic is distributed in many levels in the cranio-caudal direction and blocks the intercostal spinal nerves, causing sensory block. Providing the necessary perioperative analgesia due to the complex innervation of the breast tissue is a big controversy among anesthesiologists. Multimodal analgesia methods with various regional blocks are more preferred. Erector Spina Plane block is also preferred as another method since it provides both perioperative and postoperative analgesia
Primary Outcome Measure Information:
Title
intraoperative opioid consumption
Description
measurement with analgesia nosiception index monitor
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
postoperative changes in vas ( visual analog scor)
Description
recorde postoperative vas changes by anesthesist
Time Frame
postoperative first 24 hours.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult female patients ASA 1-3 25-70 years old were included in the study. Exclusion Criteria: Severe respiratory and heart disease liver or kidney failure coagulopathy local infection at the injection site spine or chest wall deformity allergy to drugs to be used opioid addiction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MELIHA ORHON ERGUN
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University
City
Istanbul
State/Province
Maltepe
ZIP/Postal Code
34854
Country
Turkey

12. IPD Sharing Statement

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Efect of Erector Spina Plane Block on Mastectomy

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