Comparison of PECS II Block and Combined Serratus Anterior Plane Block to Reduce Acute Pain After Mastectomy

Study Overview
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Brief Summary
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In this study, PECS II block or CSAB will be applied to patients who have had a modified radical mastectomy under general anesthesia for postoperative pain relief by using 30 ml of 0.25% bupivacaine .All patients will receive tramadol with a patient-controlled analgesia device during the postoperative period. Pain, nausea-vomiting, additional analgesic and antiemetic drug requirement, within 24 hours postoperatively will be compared between groups. In this study, it was aimed to compare the efficacy of both peripheral nerve block methods in patients after mastectomy.

Detailed Description
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Breast cancer ranks first among the most common malignant neoplasms in women. Surgery has been a mainstay of breast cancer treatment for several decades and historically, a modified radical mastectomy was the primary method of treatment for breast cancer. Poorly controlled acute postoperative pain is associated with increased morbidity, functional and quality-of-life impairment. Additionally, severe acute postoperative pain is found to be a risk factor for chronic pain. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abirritation during modified radical mastectomy, but their application is limited due to the complex nature of the procedures and serious complications. There is growing interest in the pectoralis nerve (PECS) blocks and serratus anterior block (SAB) which are less invasive as an analgesic technique during breast surgeries to reduce postoperative pain. The Pecs I block is a single injection of local anaesthetic between pectoralis major and pectoralis minor muscles at the level of the 3rd rib to anaesthetise the lateral and medial pectoral nerves. The Pecs II block is a modified Pecs I block and can be achieved with one needle insertion point. Local anaesthetic is placed between pectorals major and minor as for a Pecs I block and then between pectoralis minor and serratus anterior muscles. Numerous clinical studies focusing on the analgesic potential of PECS block in breast augmentation surgery, small breast surgery and breast cancer surgery have yielded positive results. SAD is more superficial, easy to access and less likely to have complications like PECS block. SAPB can be implemented in two ways. Deep SAB (DSAB) is applied under the serratus anterior muscle, while superficial SAB (YSAB) is applied over the serratus anterior muscle. In recent years, deep and superficial SAB, that is, combined SAB (CSAB), has been started to be applied in order to increase the effect area of local anesthetics and to prevent block failure. In this study, PECS II block or CSAB will be applied to patients who have had a modified radical mastectomy under general anesthesia for postoperative pain relief by using 30 ml of 0.25% bupivacaine .All patients will receive tramadol with a patient-controlled analgesia device during the postoperative period. Pain, nausea-vomiting, additional analgesic and antiemetic drug requirement, within 24 hours postoperatively will be compared between groups. In this study, it was aimed to compare the efficacy of both peripheral nerve block methods in patients after mastectomy.

Official Title
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Comparison of PECS II Block and Combined Serratus Anterior Plane Block to Reduce Acute Pain After Mastectomy

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Other: PECS II Block
* Other: Combined Serratus Anterior Plane Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between the ages of 18-80 Patients with ASA score I-II-III Patients with a body mass index (BMI) between 18 and 40 Patients who underwent PECS-II block or CSAB with mastectomy in the operating room Exclusion Criteria: Patients under the age of 18 and over the age of 80 Patients with an ASA score of IV and above Patients with advanced co-morbidity Patients with a history of bleeding diathesis Patients who have infection in the area which is to be blocked BMI below 18 and over 40 Patients undergoing emergency surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with PECS II Block<br> | Other: PECS II Block<br>* The Pecs II block is applied to the patients after induction of anesthesia .<br>|
| Patients with Combined Serratus Anterior Plane Block<br> | Other: Combined Serratus Anterior Plane Block<br>* Combined Serratus Anterior Plane Block is applied to the patients after induction of anesthesia .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on the Numeric Rating Scale (NRS) | Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible. | 0 hours postoperatively | 
| Pain on the Numeric Rating Scale (NRS) | Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible. | 2 hours postoperatively | 
| Pain on the Numeric Rating Scale (NRS) | Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible. | 4 hours postoperatively | 
| Pain on the Numeric Rating Scale (NRS) | Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible. | 8 hours postoperatively | 
| Pain on the Numeric Rating Scale (NRS) | Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible. | 12 hours postoperatively | 
| Pain on the Numeric Rating Scale (NRS) | Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible. | 24 hours postoperatively | 
| PONV Score | Postoperative nausea and vomiting recording in patients undergone mastectomy. 0=no PONV: patient reports no nausea and has had no emesis episodes; 1=mild PONV: patient reports nausea but declines antiemetic treatment; 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomiting. | 0 hours postoperatively | 
| PONV Score | Postoperative nausea and vomiting recording in patients undergone mastectomy. 0=no PONV: patient reports no nausea and has had no emesis episodes; 1=mild PONV: patient reports nausea but declines antiemetic treatment; 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomiting. | 2 hours postoperatively | 
| PONV Score | Postoperative nausea and vomiting recording in patients undergone mastectomy. 0=no PONV: patient reports no nausea and has had no emesis episodes; 1=mild PONV: patient reports nausea but declines antiemetic treatment; 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomiting. | 4 hours postoperatively | 
| PONV Score | Postoperative nausea and vomiting recording in patients undergone mastectomy. 0=no PONV: patient reports no nausea and has had no emesis episodes; 1=mild PONV: patient reports nausea but declines antiemetic treatment; 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomiting. | 8 hours postoperatively | 
| PONV Score | Postoperative nausea and vomiting recording in patients undergone mastectomy. 0=no PONV: patient reports no nausea and has had no emesis episodes; 1=mild PONV: patient reports nausea but declines antiemetic treatment; 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomiting. | 12 hours postoperatively | 
| PONV Score | Postoperative nausea and vomiting recording in patients undergone mastectomy. 0=no PONV: patient reports no nausea and has had no emesis episodes; 1=mild PONV: patient reports nausea but declines antiemetic treatment; 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomiting. | 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PECS II Block, Combined Serratus Anterior Plane Block, Mastectomy