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| Name | Class |
|---|---|
| CENGİZ KAYA (ckaya) | UNKNOWN |
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This study evaluates the analgesic effects of pectoralis nerve block (PECS II) and erector spinae plane block (ESP) in patients having segmental mastectomy and sentinel lymph node biopsy (SLNB). Each one-third of patients will have ESP block and pectoralis nerve block (PECS II) 30 min before general anesthesia , while other one-third of patients will have only general anesthesia.
It has been proven that PECS II and 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 II 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 / chronic pain and opioid consumption will be searched.
In this study patients are divided into three groups. Patients in PECS group will have PECS II 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.
Patients in ESP group will have ESP block in a separate section from the operating rooms (PNB practice room). In addition, PCA will be used in the first 24 hours postoperatively.
Patients in control group will not be performed nerve block. Only general anesthesia (GA) will be performed in the operation room. In addition, PCA will be used in the first 24 hours postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PECS II or ESP | Experimental | PECS II or ESP block are performed 30 minutes before general anesthesia. PCA is used for all the patients in the first 24 hours postoperatively. |
|
| Control | Active Comparator | In the control group, patients will have only general anesthesia. PCA is used for all the patients in the first 24 hours postoperatively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pectoralis nerve block II | Procedure | PECS II block will be performed 30 min. before general anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption in the first 24 hours after surgery | 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 4 points or more when the arm is in the resting position. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative acute pain | 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) | 1 day |
| Remifentanil consumption during the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The time of first analgesic demand from the PCA device. | The time of first analgesic demand was defined as the time to first PCA bolus after patient PACU arrival. | 1 day |
Inclusion Criteria:
Exclusion Criteria:
Women with breast cancer having segmental mastectomy and sentinel lymph node biopsy (SLNB)
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| Name | Affiliation | Role |
|---|---|---|
| CENGİZ KAYA, MD | Ondokuz Mayıs University Faculty of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ondokuz Mayıs University Faculty of Medicine | Samsun | 55270 | Turkey (Türkiye) |
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Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer generated generated random numbers.
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The anesthesia doctor who will perform the peripheral nerve block will be informed with a sealed envelope by an independent assistant outside the study.
| Erector spine plane block | Procedure | ESP block will be performed 30 minutes before general anesthesia. |
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| Control | Other | Only general anesthesia will be performed. |
|
Following induction of general anesthesia, anesthesia maintenance will be continued with sevoflurane to BIS 40-60 (bispectral index). When the BIS is between 40-60, 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. |
| During the surgery |
| The incidences of post-operative nausea and vomiting (PONV) | 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) | 1 day |
| The number of patient required rescue analgesia | The number of patient requires rescue analgesic will be recorded at 1-3-6-12-24. hours after surgery | 1 day |
| Post-operative chronic pain | 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) | 3. month after surgery |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D059787 | Acute Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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