Comparison of Postoperative Analgesic Effectiveness of Erector Spinae Plane Block and Combined With Superficial Parasternal Intercostal Plane Block Within the Enhanced Recovery After Cardiac Surgery (ERACS) Program: A Prospective, Randomized, Double-Blind Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ankara University
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- VAS (resting)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, 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.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
VAS (resting)
Time Frame: 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.
VAS (resting)
Time Frame: 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 Outcomes
- VAS (movement)(0-72 hours)
- Total rescue tramadol use (mg)(0-72 hours)
- Time to first rescue analgesic (min)(0-72 hours)
- Delirium incidence (Nu-DESC ≥ 2)(12, 24, 48, 72 hours)
- RASS score profile(0, 12, 24, 48, 72 hours)
- VAS (movement)(0-72 hours)
- Total rescue tramadol use (mg)(0-72 hours)
- Time to first rescue analgesic (min)(0-72 hours)
- Delirium incidence (Nu-DESC ≥ 2)(12, 24, 48, 72 hours)
- RASS score profile(0, 12, 24, 48, 72 hours)
Investigators
FATMA CANDAN YEREBAKAN
Principal Investigator
Ankara University