Postoperative Pain
Conditions
Keywords
Breast Surgery, Serratus Posterior Superior Intercostal Plane Block, SPSIP Block, Regional Anesthesia, Opioid Consumption, Postoperative Analgesia
Brief summary
This randomized, double-blind study will compare the effectiveness of three different volumes of serratus posterior superior intercostal plane block for postoperative pain control in patients undergoing unilateral breast surgery with axillary lymph node dissection. Ninety participants will be randomly assigned to receive 20 mL, 30 mL, or 40 mL of 0.25% bupivacaine. The primary outcome is total tramadol consumption during the first 24 hours after surgery. Pain scores, time to first analgesic request, rescue analgesic use, quality of recovery, postoperative nausea and vomiting, block success, and block-related complications will also be evaluated.
Interventions
DRUGBupivacaine 0.25% (20 mL)
A single ultrasound-guided serratus posterior superior intercostal plane block will be performed before general anesthesia using 20 mL of 0.25% bupivacaine. The local anesthetic will be injected between the serratus posterior superior and intercostal muscles at the T3-T4 level.
DRUGBupivacaine 0.25% (30 mL)
A single ultrasound-guided serratus posterior superior intercostal plane block will be performed before general anesthesia using 30 mL of 0.25% bupivacaine. The local anesthetic will be injected between the serratus posterior superior and intercostal muscles at the T3-T4 level.
DRUGBupivacaine 0.25% (40 mL)
A single ultrasound-guided serratus posterior superior intercostal plane block will be performed before general anesthesia using 40 mL of 0.25% bupivacaine. The local anesthetic will be injected between the serratus posterior superior and intercostal muscles at the T3-T4 level.
Sponsors
Bursa City Hospital
Ulusoy, Emre, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18 to 75 years * American Society of Anesthesiologists physical status I-III * Scheduled for elective unilateral breast surgery under general anesthesia * Able to provide written informed consent
Exclusion criteria
* Refusal to participate * Coagulopathy * Known allergy to local anesthetics or a history of local anesthetic systemic toxicity * Liver or kidney failure * Uncontrolled diabetes mellitus * Uncontrolled hypertension * Cognitive impairment or inability to understand the study procedures * Chronic pain requiring opioid therapy * Current antidepressant use * Neuropathic pain * Infection at the block injection site * Pregnancy, suspected pregnancy, or breastfeeding * Clinically significant frailty
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Postoperative Tramadol Consumption | During the first 24 hours after surgery | Cumulative tramadol consumption delivered through patient-controlled analgesia will be recorded in milligrams and compared among the 20 mL, 30 mL, and 40 mL SPSIP block groups. Higher values indicate greater opioid consumption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity | At 0, 2, 4, 8, 16, and 24 hours after surgery | Pain intensity will be assessed using the 11-point Numerical Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain). Static pain will be evaluated at rest. Dynamic pain will be evaluated during 30-60 degrees of arm abduction on the operated side and during deep inspiration. Higher scores indicate greater pain intensity. |
| Quality of Recovery-15 Score | At 24 hours after surgery | Postoperative quality of recovery will be assessed using the Quality of Recovery-15 questionnaire. The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery. |
Countries
Turkey (Türkiye)
Contacts
CONTACTEMRE ULUSOY, MD
Outcome results
None listed