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This randomized prospective study aims to compare the analgesic efficacy of serratus posterior superior intercostal plane (SPSIP) block and standard local anesthetic infiltration in patients undergoing port catheter implantation.
This prospective, randomized controlled study evaluates the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block compared with standard local anesthetic infiltration in patients undergoing port catheter implantation. Although the procedure is usually performed under local anesthesia, patients may experience significant pain during port pocket creation.
Participants will be randomized in a 1:1 ratio to receive either ultrasound-guided SPSIP block or local anesthetic infiltration. All patients will receive standardized monitoring and premedication. Pain intensity during different procedural stages, postoperative pain scores, analgesic consumption, and satisfaction levels will be assessed.
The study aims to determine whether SPSIP block improves intraoperative analgesia and reduces analgesic requirements compared to local infiltration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block | Experimental | Participants will receive an ultrasound-guided SPSIP block prior to port catheter implantation. |
|
| Local Infiltration | Active Comparator | Participants will receive standard local anesthetic infiltration during port catheter implantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block | Procedure | Ultrasound-guided Serratus Posterior Superior Intercostal plane block performed prior to the procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity during port pocket creation | Pain intensity during port pocket creation measured using the Numeric Rating Scale (0-10), where higher scores indicate greater pain. Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain. | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum intraoperative pain score | The highest pain intensity recorded during any procedural stage will be assessed using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. | During the procedure |
| Pain intensity during procedural stages |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fatma Acil, M.D. | Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fatma Acil | Diyarbakır | Outside of the US | 21070 | Turkey (Türkiye) |
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Participants will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIP block) or local anesthetic infiltration. Both groups will undergo the procedure under standardized conditions, and outcomes will be compared between parallel groups.
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Participants and care providers will not be blinded due to the nature of the interventions. Investigators responsible for data analysis and outcome assessors responsible for postoperative evaluations will be blinded to group allocation.
|
| Local Anesthetic Infiltration | Procedure | Standard local anesthetic infiltration performed at the surgical site during port catheter implantation. |
|
Pain intensity will be assessed during skin puncture, catheter tunneling, and skin closure using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. |
| During the procedure |
| Total supplemental local anesthetic amount | Total amount of additional local anesthetic administered during the procedure will be recorded in milliliters. | During the procedure |
| Postoperative pain scores | Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. | 0, 2, 6, 12, and 24 hours after the procedure |
| Total tramadol consumption | Total intravenous tramadol consumption within the first 24 hours after the procedure will be recorded in milligrams. | Within 24 hours after the procedure |
| Duration of effective analgesia | Duration of effective analgesia will be defined as the time interval from completion of the procedure to the first administration of rescue analgesia. | Within 24 hours after the procedure |
| Patient satisfaction score | Patient satisfaction will be assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied. Higher scores indicate greater satisfaction. | After the procedure |
| Surgeon satisfaction score | Surgeon satisfaction will be assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied. Higher scores indicate greater satisfaction. | After the procedure |
| Procedure-related complications | Procedure-related complications, including pneumothorax, hematoma, local anesthetic systemic toxicity, methemoglobinemia, and infection, will be recorded. | During and within 24 hours after the procedure |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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