Acute Pain, Analgesia, Anesthesia, Chronic Pain, Erector Spine Plane Block, Patient Controlled Analgesia, Pectoralis Nerve Block
Conditions
Keywords
Regional Anesthesia, Acute and chronical pain, Pectoralis nerve block, Erector spine plane block
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPectoralis nerve block II
PECS II block will be performed 30 min. before general anesthesia.
PROCEDUREErector spine plane block
ESP block will be performed 30 minutes before general anesthesia.
OTHERControl
Only general anesthesia will be performed.
Sponsors
CENGİZ KAYA (ckaya)
Ondokuz Mayıs University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
The anesthesia doctor who will perform the peripheral nerve block will be informed with a sealed envelope by an independent assistant outside the study.
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 generated random numbers.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ASA 1-2 patients between the age of 18-65, scheduled for elective unilateral segmental mastectomy + sentinel lymph node biopsy
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 (coagulopathy, 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 or communication difficulties * Patients with chest deformity * Patients with previous breast surgery except diagnostic biopsies * Patients who do not want to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption in the first 24 hours after surgery | 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 4 points or more when the arm is in the resting position. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative acute pain | 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) |
| Remifentanil consumption during the surgery | During the surgery | 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. |
| The number of patient required rescue analgesia | 1 day | The number of patient requires rescue analgesic will be recorded at 1-3-6-12-24. hours after surgery |
| Post-operative chronic pain | 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) |
| The incidences of post-operative nausea and vomiting (PONV) | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| The time of first analgesic demand from the PCA device. | 1 day | The time of first analgesic demand was defined as the time to first PCA bolus after patient PACU arrival. |
Countries
Turkey (Türkiye)
Outcome results
None listed