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This prospective, randomized, double-blind, parallel-group clinical trial within the Enhanced Recovery After Cardiac Surgery (ERACS) program compares postoperative analgesic effectiveness of bilateral erector spinae plane (ESP) block versus ESP combined with superficial parasternal intercostal plane (SPIP) block in adult patients undergoing elective cardiac surgery via median sternotomy.
Rationale: Effective multimodal, opioid-sparing analgesia is crucial in cardiac surgery to enhance recovery and reduce pulmonary and cognitive complications. Neuraxial techniques (e.g., epidural) carry increased hematoma risk under anticoagulation; hence, fascial plane blocks like ESP and SPIP are safer alternatives.
Methodology: Randomized (ResearchRandomizer.org), 1:1 allocation, opaque sealed envelopes. ESP and SPIP performed under ultrasound guidance at standardized doses and locations.
Blinding: Patients and postoperative evaluators are blinded; block-performing anesthesiologist unblinded but uninvolved in assessment.
Follow-up: 0-72 hours after extubation with predefined time points for VAS, RASS, and Nu-DESC evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Erector Spinae Plane Block (Group E) | Experimental | After induction of general anesthesia, patients will receive a bilateral ultrasound-guided erector spinae plane block at the T4--T5 vertebral level. A total of 30 mL of 0.25% bupivacaine per side (prepared as 10 mL saline + 10 mL 0.5% bupivacaine per syringe) will be injected into the deep fascial plane beneath the erector spinae muscle using an 80 mm block needle under aseptic conditions. The spread of the local anesthetic will be observed in a craniocaudal direction in real time. The procedure will be repeated bilaterally. All patients will subsequently receive standardized postoperative analgesia with paracetamol 1 g IV every 6 hours; if VAS > 4, tramadol 50 mg IV will be given as rescue analgesia. |
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| Erector Spinae Plane Block + Superficial Parasternal Intercostal Plane Block (Group EP) | Active Comparator | Following induction of general anesthesia, patients will receive a bilateral ESP block (same technique as in Group E) with 20 mL of 0.25% bupivacaine per side. Afterward, a bilateral superficial parasternal intercostal plane block (SPIP) will be performed in the 4th-5th intercostal spaces, approximately 2-3 cm lateral to the midline, using a linear ultrasound probe and 80 mm block needle. After confirming negative aspiration and hydrodissection with 1-3 mL saline, 10 mL of 0.25% bupivacaine per side will be injected into the interfacial plane. The total local anesthetic volume for both blocks combined will be 60 mL, kept below the toxic threshold. Standard postoperative analgesia will be identical to Group E (paracetamol 1 g IV every 6 hours, and tramadol 50 mg IV if VAS > 4). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure: Erector Spinae Plane (ESP) Block | Procedure | A bilateral ultrasound-guided erector spinae plane block will be performed at the T4-T5 vertebral level after induction of general anesthesia. Using an 80 mm peripheral nerve block needle and an in-plane approach, 30 mL of 0.25% bupivacaine per side will be injected into the fascial plane deep to the erector spinae muscle. The spread of the local anesthetic will be visualized in real time in a craniocaudal direction. This technique provides multidermatomal somatic and visceral analgesia (approximately T2-T9). |
| Measure | Description | Time Frame |
|---|---|---|
| VAS (resting) | Average of VAS scores at 0, 1, 6, 12, 24, 48, and 72 hours after extubation (t=0). Lower scores indicate better analgesia. Pain was assessed using the 0-10 Visual Analog Scale (VAS). Pain severity was classified as follows: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Rescue analgesia was administered when VAS score was > 4. | Up to 72 hours post-extubation |
| Measure | Description | Time Frame |
|---|---|---|
| VAS (movement) | Mean VAS scores during movement at all time points | 0-72 hours |
| Total rescue tramadol use (mg) | Cumulative IV tramadol dose |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara University Faculty of Medicine | Ankara | 06230 | Turkey (Türkiye) |
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This study is designed as a prospective, randomized, double-blind, parallel-group clinical trial conducted within the Enhanced Recovery After Cardiac Surgery (ERACS) program.
A total of 42 adult patients undergoing elective cardiac surgery via median sternotomy will be randomized in a 1:1 ratio into two groups using a computer-generated randomization sequence and sealed opaque envelopes.
Group E: Bilateral erector spinae plane (ESP) block
Group EP: Bilateral ESP block combined with superficial parasternal intercostal plane (SPIP) block
Both interventions will be performed under ultrasound guidance after induction of general anesthesia.
Postoperative assessments-including VAS pain scores, sedation (RASS), and delirium screening (Nu-DESC)-will be recorded at standardized time points up to 72 hours after extubation.
The study aims to compare postoperative analgesic effectiveness and the impact of pain control on postoperative delirium.
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The study will be double-blind, meaning neither the researchers nor the participants will know which treatment group they belong to, ensuring unbiased outcome assessment.
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| Erector Spinae Plane (ESP) Block + Superficial Parasternal Intercostal Plane (SPIP) Block | Procedure | After induction of general anesthesia, patients will receive: Bilateral ESP block with 20 mL of 0.25% bupivacaine per side, performed as described above at the T5 level, and Bilateral SPIP block performed at the 4th-5th intercostal spaces, approximately 2-3 cm lateral to the midline, using a linear ultrasound probe. For the SPIP block, after confirming needle placement with hydrodissection (1-3 mL saline) and negative aspiration, 10 mL of 0.25% bupivacaine per side will be injected between the pectoralis major and external intercostal muscles. |
|
| 0-72 hours |
| Time to first rescue analgesic (min) | Time between extubation and first rescue tramadol | 0-72 hours |
| Delirium incidence (Nu-DESC ≥ 2) | Nursing Delirium Screening Scale (Nu-DESC) score ≥ 2 Delirium was assessed using the Nursing Delirium Screening Scale (NU-DESC). NU-DESC consists of five items, each scored from 0 to 2 (total score: 0-10). A total NU-DESC score ≥ 2 was considered positive for delirium. Items: Disorientation Inappropriate behavior Inappropriate communication Illusions / hallucinations Psychomotor retardation | 12, 24, 48, 72 hours |
| RASS score profile | Richmond Agitation-Sedation Scale distribution Sedation level was assessed using the Richmond Agitation-Sedation Scale (RASS). RASS scores were classified as:
| 0, 12, 24, 48, 72 hours |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D010268 | Parapsychology |
| D003766 | Dental Occlusion |
| ID | Term |
|---|---|
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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