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This prospective, randomized, assessor-blinded study will compare serratus posterior superior intercostal plane block and erector spinae plane block in adult female patients undergoing unilateral breast surgery. The primary outcome is chronic postoperative pain at 3 months, assessed using the Brief Pain Inventory-Short Form.
This single-center, prospective, randomized, controlled, assessor-blinded study will include adult female patients scheduled for elective unilateral breast surgery. Participants will be randomized in a 1:1 ratio to receive either serratus posterior superior intercostal plane block or erector spinae plane block before general anesthesia.
The study aims to compare the effects of these two regional anesthesia techniques on chronic postoperative pain at 3 months. Chronic pain will be assessed using the Brief Pain Inventory-Short Form.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPSIP Block | Active Comparator | Participants will receive an ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) with 30 mL of 0.25% bupivacaine prior to induction of general anesthesia. |
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| ESPB Block | Active Comparator | Participants will receive an ultrasound-guided erector spinae plane block (ESPB) with 30 mL of 0.25% bupivacaine prior to induction of general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block | Procedure | An ultrasound-guided interfascial plane block performed between the serratus posterior superior muscle and the underlying ribs prior to general anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Postoperative Pain Assessed by the Brief Pain Inventory-Short Form | Chronic postoperative pain will be assessed using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF assesses pain severity (worst, least, average, and current pain) and pain interference with daily activities. Pain severity items are scored on a 0-10 numeric rating scale (0 = no pain; 10 = pain as bad as you can imagine). Pain interference items are scored on a 0-10 numeric rating scale (0 = does not interfere; 10 = completely interferes). Higher scores indicate worse pain severity and greater pain-related interference. | Time Frame: T0: 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathic Pain Assessed by the DN4 Questionnaire | Neuropathic pain will be assessed using the Douleur Neuropathique 4 Questions (DN4) questionnaire. The DN4 consists of 10 items with a total score ranging from 0 to 10 (0 = no neuropathic pain characteristics; 10 = all neuropathic pain characteristics present). Higher scores indicate a greater likelihood of neuropathic pain. A total score of 4 or higher is considered indicative of neuropathic pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Engin Çetin, M.D. | Contact | 05321206004 | 90 | Doccetin52@gmail.com |
| Engin Çetin, M.D | Contact | 05321206004 | 90 | Doccetin52@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Engin Çetin, M.D | Kocaeli City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences Kocaeli City Hospital | İzmit | Kocaeli | 41200 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Participants will be randomized in a 1:1 ratio to receive either serratus posterior superior intercostal plane block (SPSIPB) or erector spinae plane block (ESPB)
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The patient and the outcome assessor will be blinded to group allocation. The anesthesiologist performing the block will not be blinded.
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| Ultrasound-guided Erector Spinae Plane Block | Procedure | An ultrasound-guided erector spinae plane block performed prior to induction of general anesthesia using 30 mL of 0.25% bupivacaine. |
|
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| T0: 3 months postoperatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |