Postoperative Delirium, Postoperative Pain Management, Sternotomy
Conditions
Keywords
sternotomy, post-sternotomy pain, postoperative pain, postoperative delirium, erector spinae plane blocks, superficial parasternal intercostal plane blocks
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREProcedure: Erector Spinae Plane (ESP) Block
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).
PROCEDUREErector Spinae Plane (ESP) Block + Superficial Parasternal Intercostal Plane (SPIP) Block
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.
Sponsors
Ankara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for elective cardiac surgery via median sternotomy under the ERACS protocol * Age between 18 and 80 years * ASA physical status II-III * Body Mass Index (BMI) between 18 and 35 kg/m² * No cognitive impairment (able to cooperate and follow commands) * No history of chronic pain or regular analgesic use * Provided written informed consent after detailed explanation of the study
Exclusion criteria
* Age \< 18 years or \> 80 years * ASA physical status ≥ IV * Emergency surgery * Pregnant or breastfeeding women * Redo coronary artery bypass surgery * Pre-existing cognitive disorder or psychiatric illness affecting pain or delirium evaluation * Infection or skin lesion at the injection site * Known allergy or hypersensitivity to local anesthetics (bupivacaine or amide type) * Chronic pain or opioid use prior to surgery * Unwillingness to participate or withdrawal of consent at any stage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS (resting) | Up to 72 hours post-extubation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS (movement) | 0-72 hours | Mean VAS scores during movement at all time points |
| Total rescue tramadol use (mg) | 0-72 hours | Cumulative IV tramadol dose |
| Time to first rescue analgesic (min) | 0-72 hours | Time between extubation and first rescue tramadol |
| Delirium incidence (Nu-DESC ≥ 2) | 12, 24, 48, 72 hours | 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 |
| RASS score profile | 0, 12, 24, 48, 72 hours | Richmond Agitation-Sedation Scale distribution Sedation level was assessed using the Richmond Agitation-Sedation Scale (RASS). RASS scores were classified as: * 4 = combative, * 3 = very agitated, * 2 = agitated, * 1 = restless, 0 = alert and calm, * 1 = drowsy, * 2 = light sedation, * 3 = moderate sedation, * 4 = deep sedation, * 5 = unarousable. |
Countries
Turkey (Türkiye)
Outcome results
None listed