Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025-KAEK-47 | Other Identifier | Clinical Research Ethics Committee of University of Health Sciences Bursa Faculty of Medicine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bursa City Hospital | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
This prospective randomized double-blind controlled trial aims to compare the postoperative analgesic efficacy and dermatomal spread of rhomboid intercostal-subserratus plane (RISS) block and serratus posterior superior intercostal plane (SPSIP) block in patients undergoing modified radical mastectomy. Postoperative pain scores, opioid consumption, rescue analgesic requirements, block-related complications, and quality of recovery outcomes will be evaluated.
Breast cancer surgery is frequently associated with moderate to severe postoperative pain, which may negatively affect recovery and increase opioid consumption. Ultrasound-guided fascial plane blocks have become an important component of multimodal analgesia strategies for breast surgery.
The rhomboid intercostal-subserratus plane (RISS) block and serratus posterior superior intercostal plane (SPSIP) block are recently described regional anesthesia techniques that may provide effective postoperative analgesia by blocking the lateral and posterior branches of the thoracic spinal nerves. However, comparative clinical evidence regarding their analgesic efficacy and dermatomal coverage in modified radical mastectomy remains limited.
This prospective randomized double-blind controlled trial will compare RISS block and SPSIP block in adult patients undergoing modified radical mastectomy under general anesthesia. Participants will be randomly allocated to receive either RISS block or SPSIP block before surgery. The primary objective is to compare postoperative opioid consumption. Secondary outcomes include postoperative pain scores, dermatomal sensory spread, time to first rescue analgesia, quality of recovery, opioid-related adverse events, and block-related complications.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RISS Block | Experimental | Patients will receive an ultrasound-guided rhomboid intercostal-subserratus plane (RISS) block before modified radical mastectomy for postoperative analgesia. |
|
| SPSIP Block | Experimental | Patients will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block before modified radical mastectomy for postoperative analgesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhomboid Intercostal-Subserratus Plane Block | Procedure | Ultrasound-guided rhomboid intercostal-subserratus plane block performed before modified radical mastectomy for postoperative analgesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Postoperative Opioid Consumption | Total opioid consumption during the first 24 hours after modified radical mastectomy. | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Scores | Postoperative pain intensity measured using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. | 0-24 hours after surgery |
| Compartmental Pain Scores Using Numeric Rating Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yusuf Alan, MD | Contact | +905396210977 | dryusufalan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mürsel Ekinci, MD | Bursa City Hospital | Principal Investigator |
| Yusuf Alan, MD | Bursa City Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bursa City Hospital | Recruiting | Bursa | Nilüfer | 16100 | Turkey (Türkiye) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
Participants will be randomized in a 1:1 ratio to receive either a Rhomboid Intercostal-Subserratus Plane (RISS) block or a Serratus Posterior Superior Intercostal Plane (SPSIP) block before modified radical mastectomy. Outcomes will be compared between two parallel groups.
Not provided
Not provided
Participants and outcome assessors will be blinded to group allocation. Regional blocks will be performed by an anesthesiologist not involved in postoperative assessments.
| Serratus Posterior Superior Intercostal Plane Block | Procedure | Ultrasound-guided serratus posterior superior intercostal plane block performed before modified radical mastectomy for postoperative analgesia. |
|
Numeric Rating Scale (NRS) score (0-10 points) measured separately for axillary pain, anterolateral chest wall pain, and surgical drain insertion site pain. A score of 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. |
| 0-24 hours after surgery |
| Dermatomal Sensory Block Distribution | Number of dermatomes blocked, assessed by pinprick sensory testing 30 minutes after block performance. Higher values indicate wider sensory block distribution. | 30 minutes after block performance |
| Quality of Recovery-15 Score | Quality of Recovery-15 (QoR-15) questionnaire score ranging from 0 to 150, where higher scores indicate better postoperative recovery and patient satisfaction. | 24 hours after surgery |
| Intraoperative Remifentanil Consumption | Total intraoperative remifentanil consumption will be recorded and compared between groups. | During surgery |
| Block- and Opioid-Related Complications | Complications related to block performance and opioid use will be recorded. | 24 hours after surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |