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The aim of researchers is to compare the effects of three different local anesthetic concentrations and volumes on opioid consumption, postoperative analgesic efficacy, and pain scores during ultrasound-guided SPSIP blocks in patients undergoing modified radical mastectomy. Additionally, we aim to map and identify the dermatomal areas where different concentrations and volumes of SPSIP blocks provide analgesia.
The researchers' hypothesis is that a lower concentration but higher volume of SPSIP block could provide similar analgesic efficacy to a higher concentration and lower volume block, while also improving the safety profile in terms of local anesthetic systemic toxicity by reducing the total local anesthetic load. In other words, we believe that using less than the 0.25% bupivacaine used in previous studies on this block could provide similar analgesic efficacy. This is because, in fascial plane blocks, separating the fascia is as important a technique as the local anesthetic administered. Facial plane blocks are volume-dependent blocks.
The Modified Aldrete scoring system is a routine assessment performed in our clinic's postoperative recovery room to determine whether a patient has recovered. Patients with an NRS score of 4 or higher, despite routine analgesia, will receive 50 mg tramadol hydrochloride as a rescue analgesic, administered intravenously over 30 minutes in 150 ml of saline solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 ml of 0.25% Bupivacaine | Active Comparator | A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 30 ml of 0.25% bupivacaine (15 ml of the drug + 15 ml of isotonic solution). |
|
| 40 ml of 0.125% Bupivacaine | Active Comparator | A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 40 ml of 0.125% bupivacaine (10 ml of the drug + 30 ml of isotonic solution). |
|
| 50 ml of 0.125% bupivacaine | Active Comparator | A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 50 ml of 0.125% bupivacaine (12.5 ml of the drug + 37.5 ml of isotonic solution). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serratus Posterior Superior Intercostal Plane (SPSIP) block 40 ml of 0.125% bupivacaine | Procedure | A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 40 ml of 0.125% bupivacaine (10 ml of the drug + 30 ml of isotonic solution). |
| Measure | Description | Time Frame |
|---|---|---|
| Total tramadol consumption | Postoperative total analgesic need was recorded as "milligram" in unit. | Postoperative 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Dermatome Area | Thirty minutes after the block procedure, we will perform a pinprick test by inserting a sterile needle from the tip of the syringe into the patient's skin and recording the areas where skin analgesia has developed. | 30th minute after the block |
| Numeric Rating Scale (NRS) Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| OĞUZ GÜNDOĞDU | Contact | +905545945469 | oguzgundogdu@cumhuriyet.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sivas Cumhuriyet University | Sivas | Sivas | 58140 | Turkey (Türkiye) |
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| Serratus Posterior Superior Intercostal Plane (SPSIP) 50 ml of 0.125% bupivacaine | Procedure | A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 50 ml of 0.125% bupivacaine (12.5 ml of the drug + 37.5 ml of isotonic solution). |
|
| Serratus Posterior Superior Intercostal Plane (SPSIP) 30 ml of 0.25% bupivacaine | Procedure | A Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed using 30 ml of 0.25% bupivacaine (15 ml of the drug + 15 ml of isotonic solution). |
|
Description: Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain |
| Postoperative 24 hours |
| 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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| ID | Term |
|---|---|
| D003766 | Dental Occlusion |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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