Mastectomy, Postoperative Pain, Quality of Recovery After Mastectomy, Serratus Anterior Plane Block
Conditions
Keywords
Serratus Anterior Plane Block, Postoperative Pain, Mastectomy, Regional Anesthesia, Pain Management, Bupivacaine, Quality of Recovery, CRP, Neutrophil-Lymphocyte Ratio, Inflammation, Breast Surgery
Brief summary
Postoperative pain following mastectomy may adversely affect early mobilization, patient comfort, and overall quality of recovery. Serratus anterior plane block is an ultrasound-guided regional anesthesia technique that provides analgesia to the anterolateral thoracic wall and is increasingly used as part of multimodal analgesia for breast surgery. Although the analgesic efficacy of serratus anterior plane block has been investigated in breast surgery, the clinical impact of the timing of block administration remains insufficiently defined. This prospective, randomized, controlled, patient and assessor blinded clinical trial will compare two different timings of ultrasound-guided serratus anterior plane block in adult female patients undergoing elective unilateral mastectomy under general anesthesia. Participants will be randomized to receive serratus anterior plane block either after induction of general anesthesia and before surgical incision, or after completion of surgery and before extubation. In both groups, the block will be performed under ultrasound guidance using 25 mL of 0.25% bupivacaine. The primary outcome is postoperative quality of recovery at 24 hours, assessed using the Quality of Recovery-15 questionnaire. Secondary outcomes include postoperative pain scores at predefined time points during the first 24 postoperative hours, intraoperative remifentanil consumption, postoperative opioid and non-opioid analgesic requirements, time to first analgesic requirement, postoperative nausea and vomiting, length of hospital stay, complications, inflammatory response markers including CRP and neutrophil-to-lymphocyte ratio, and intraoperative hemodynamic variables. The study is planned to enroll 80 participants at a single tertiary training and research hospital. The findings are expected to clarify whether preincisional administration of serratus anterior plane block provides superior postoperative recovery, analgesic efficacy, and modulation of inflammatory response compared with administration at the end of surgery.
Interventions
PROCEDUREUltrasound-Guided Serratus Anterior Plane Block
Ultrasound-guided serratus anterior plane block will be performed under general anesthesia on the operative side. With the patient in the supine position and the ipsilateral arm abducted, a high-frequency linear ultrasound probe will be placed at the midaxillary line around the fourth to fifth intercostal level. After identification of the latissimus dorsi and serratus anterior muscles, the block needle will be advanced using an in-plane technique, and 25 mL of 0.25% bupivacaine will be injected into the fascial plane between these muscles after negative aspiration. In the preincisional arm, the block will be performed after induction of general anesthesia and before surgical incision. In the end-of-surgery arm, the same block will be performed after completion of surgery and before extubation.
DRUGBupivacaine
Bupivacaine 0.25%, 25 mL (62.5 mg), will be administered as a single ultrasound-guided injection into the serratus anterior plane on the operative side. In the preincisional arm, administration will occur after induction of general anesthesia and before surgical incision. In the end-of-surgery arm, administration will occur after completion of surgery and before extubation.
Sponsors
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18 years or older * Scheduled for elective unilateral mastectomy surgery * Planned to undergo surgery under general anesthesia * American Society of Anesthesiologists physical status I-III * Willing and able to participate in the study * Provision of written informed consent
Exclusion criteria
* Refusal to participate in the study * Known allergy to local anesthetics planned for use in the study * Chronic opioid use * Current steroid or immunosuppressive therapy * Presence of chronic inflammatory disease * Surgical duration shorter than 30 minutes * Active infection * Coagulopathy * Infection at the planned block site * Pregnancy or lactation * Advanced hepatic failure or advanced renal failure * Reoperation due to recurrent disease * Inability to communicate adequately or to provide reliable pain scores * Psychiatric or neurological condition limiting reliable completion of the QoR-15 questionnaire or Numeric Rating Scale assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Quality of Recovery at 24 Hours | 24 hours after surgery | Postoperative quality of recovery will be assessed using the Quality of Recovery-15 questionnaire. The postoperative 24-hour QoR-15 score will be compared between the preincisional serratus anterior plane block group and the end-of-surgery serratus anterior plane block group. Higher scores indicate better quality of recovery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting Postoperative Pain Scores | Postoperative 0 to 24 hours | Resting pain intensity will be assessed using the Numeric Rating Scale at postoperative 0, 1, 4, 8, 12, 16, 20, and 24 hours. |
| Intraoperative Remifentanil Consumption | During surgery | Total intraoperative remifentanil consumption will be recorded and compared between groups. |
| Postoperative Opioid Consumption | Postoperative 0 to 24 hours | Total opioid consumption during the first 24 postoperative hours will be calculated based on tramadol use. |
| Postoperative Non-Opioid Analgesic Consumption | Postoperative 0 to 24 hours | Total non-opioid analgesic consumption during the first 24 postoperative hours will be recorded, including paracetamol use. |
| Time to First Analgesic Requirement | Postoperative 0 to 24 hours | The time from admission to the postoperative recovery unit to the first requirement for rescue analgesia will be recorded. |
| Postoperative Nausea and Vomiting | Postoperative 0 to 24 hours | The occurrence of postoperative nausea and vomiting will be assessed during the first 24 postoperative hours. |
| Length of Hospital Stay | From surgery until hospital discharge, assessed up to 30 days. | Length of hospital stay will be recorded as the number of days from surgery to discharge. |
| C-Reactive Protein Level | Postoperative 6 hours | Serum C-reactive protein concentration will be measured as a marker of postoperative inflammatory response and reported in mg/L. |
| White Blood Cell Count | Postoperative 6 hours | Absolute neutrophil count will be measured from the complete blood count and reported in ×10\^9/L. |
| Absolute Neutrophil Count | Postoperative 6 hours | Absolute neutrophil count will be measured from the complete blood count and reported in ×10\^9/L. |
| Absolute Lymphocyte Count | Postoperative 6 hours | Absolute lymphocyte count will be measured from the complete blood count and reported in ×10\^9/L. |
| Neutrophil-to-Lymphocyte Ratio | Postoperative 6 hours | The neutrophil-to-lymphocyte ratio will be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count. The ratio is unitless. |
| Intraoperative Heart Rate | From induction of general anesthesia to completion of surgery | Heart rate will be recorded in beats per minute during the intraoperative period and compared between groups. |
| Intraoperative Mean Arterial Pressure | From induction of general anesthesia to completion of surgery | Mean arterial pressure will be recorded in mmHg during the intraoperative period and compared between groups. |
Countries
Turkey (Türkiye)
Contacts
CONTACTFatma Çiğdem ÖZAKIN, MD
PRINCIPAL_INVESTIGATORFatma Çiğdem ÖZAKIN, MD
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Outcome results
None listed