Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04824300
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2021-03-27
Brief Title:
Efect of Erector Spina Plane Block on Mastectomy
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
The Effect of Erector Spina Plane Block on Postoperative Pain and Opiod Consumption After Mastectomy
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
After breast cancer surgery more than 60 of patients experience persistent painAlthough 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 vomitingErector spina plane block ESPB is a technique used in many surgeries for anesthesia and analgesiaIt is frequently preferred by anesthesiologists for postoperative analgesia recently because it is easy to apply and no complications are reported in the literatureESPB with arms of iliocostalis longissimus and spinalis is located parallel to the spine from the back of the skull to the pelvisThe injected local anesthetic is distributed in many levels in the cranio-caudal direction and blocks the intercostal spinal nerves causing sensory blockProviding the necessary perioperative analgesia due to the complex innervation of the breast tissue is a big controversy among anesthesiologistsMultimodal analgesia methods with various regional blocks are more preferredESPB block is also preferred as another method since it provides both perioperative and postoperative analgesiaIn studies conducted on cadavers it has been shown that local analgesia spreads to the paravertebral area when applied under the Erektor Spina muscleTechnically compared to the paravertebral blockthe 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 painAnalyzes the instantaneous changes in heart rate due to the activation of the parasympathetic nervous system using respiratory sinus arrhythmiaA value between 0-100 is obtainedIf parasympathetic modulation is very low a value of 0 is obtained if it is high a value of 100 is obtainedANI 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 sufficientand values 50 are the following 10 minutesHemodynamic reactivity 20 increase in heart rate or blood pressure will occur and the level of analgesia is insufficientand values 70 indicate that there is no painful stimulus or that more analgesic drugs are used
ANI is a monitoring method used in the evaluation of acute nociception and painAnalyzes the instantaneous changes in heart rate due to the activation of the parasympathetic nervous system using respiratory sinus arrhythmiaA value between 0-100 is obtainedIf parasympathetic modulation is very low a value of 0 is obtained if it is high a value of 100 is obtainedANI 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 sufficientand values 50 are the following 10 minutesHemodynamic reactivity 20 increase in heart rate or blood pressure will occur and the level of analgesia is insufficientand 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 21 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 21 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 21 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 21 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
ANI is a monitoring method used in the evaluation of acute nociception and pain Figure 21 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 21 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 21 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 21 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None