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This randomized, double-blind, placebo-controlled study aims to evaluate the effect of the serratus posterior superior intercostal plane (SPSIP) block on postoperative pain and opioid consumption in patients undergoing minimally invasive cardiac valve surgery via mini-thoracotomy.
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block in patients undergoing minimally invasive cardiac valve surgery via mini-thoracotomy. Postoperative pain following thoracic cardiac surgery may impair respiratory function and delay recovery, making effective analgesia essential.
Participants will be randomly assigned to receive an ultrasound-guided SPSIP block with either bupivacaine or normal saline under identical conditions. All patients will receive standardized general anesthesia and postoperative multimodal analgesia. Blinding will be ensured for patients and outcome assessors.
The study aims to determine whether SPSIP block with local anesthetic reduces postoperative opioid consumption and improves pain control compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block with Bupivacaine | Experimental | Participants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block with bupivacaine prior to surgery, in addition to standard general anesthesia and multimodal analgesia. |
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| Serratus Posterior Superior Intercostal Plane Block with Saline | Placebo Comparator | Participants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block with normal saline under identical conditions, in addition to standard general anesthesia and multimodal analgesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serratus Posterior Superior Intercostal Plane Block With Bupivacaine | Procedure | Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block prior to surgery using 30 mL of 0.25% bupivacaine, in addition to standard general anesthesia and multimodal analgesia. |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour cumulative opioid consumption | Total opioid consumption within the first 24 hours after surgery, expressed as intravenous morphine milligram equivalents (IV-MME). | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain intensity at rest (NRS) | Pain intensity at rest measured using the Numeric Rating Scale (0-10). | 4, 6, 12, and 24 hours after surgery |
| Postoperative pain during movement (NRS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatma Acil, M.D. | Contact | +905337225225 | acilfatma@gmail.com |
| 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 | Recruiting | Diyarbakır | Outside of the US | 21070 | Turkey (Türkiye) |
De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared.
Starting 6 months and ending 36 months following article publication.
Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to acilfatma@gmail.com
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Participants will be randomly assigned in a 1:1 ratio to receive either SPSIP block with bupivacaine or SPSIP block with saline. Both groups will undergo identical procedures under standardized conditions, and outcomes will be compared between parallel groups.
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Participants, care providers, investigators, and outcome assessors will be blinded to group allocation. Study solutions (bupivacaine or normal saline) will be prepared by an independent anesthesiologist according to the randomization sequence. The syringes will be identical in appearance, volume, and labeling. The anesthesiologist performing the block will not be aware of the syringe content.
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| Serratus Posterior Superior Intercostal Plane Block With Saline | Procedure | Participants in this group will receive an ultrasound-guided placebo block using 30 mL of normal saline under identical conditions, in addition to standard general anesthesia and multimodal analgesia. |
|
Pain intensity during coughing or deep breathing measured using the Numeric Rating Scale (0-10).
| 4, 6, 12, and 24 hours after surgery |
| Time to first rescue analgesia | Time from the end of surgery to the first administration of rescue analgesia. | Within 24 hours after surgery |
| Time to extubation | Time from the end of surgery to extubation. | From the end of surgery until extubation, assessed up to 24 hours |
| Length of intensive care unit stay | Duration of stay in the intensive care unit. | Through study completion, an average of 48 hours |
| Length of hospital stay | Total duration of hospitalization. | From date of admission until discharge, up to 30 days |
| Inspiratory Spirometry Test | Inspiratory spirometry performance will be assessed using an incentive spirometer. Inspiratory capacity will be estimated based on the number of rising balls: 1 ball = 600 mL, 2 balls = 900 mL, and 3 balls = 1200 mL. The score ranges from a minimum of 1 ball to a maximum of 3 balls, with higher scores indicating better inspiratory function. | 4, 6, 12, and 24 hours after surgery |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| 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 |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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