Coronary Artery Bypass Grafting, Postoperative Pain
Conditions
Keywords
Serratus Anterior Plane Block, PECS II Block, Regional Anesthesia, Opioid-Sparing, Coronary Artery Bypass Grafting, post operative pain
Brief summary
This prospective randomized placebo-controlled trial was designed to evaluate the effects of ultrasound-guided bilateral pectoralis (PECS II) and serratus anterior plane (SAP) blocks on postoperative recovery in adult patients undergoing elective coronary artery bypass grafting (CABG). Patients were randomized to receive bilateral PECS II block, bilateral SAP block, or bilateral sham fascial plane injections in addition to standardized systemic analgesia. The study evaluated postoperative pain intensity using the Visual Analog Scale (VAS), opioid consumption, postoperative nausea and vomiting (PONV), block-related complications, duration of mechanical ventilation, time to first mobilization, and intensive care unit (ICU) length of stay.
Detailed description
This prospective, randomized, placebo-controlled trial evaluated the postoperative analgesic efficacy of ultrasound-guided bilateral serratus anterior plane (SAP) block and bilateral PECS II block in adult patients undergoing elective coronary artery bypass grafting (CABG). Participants were randomly assigned to one of three groups: bilateral SAP block, bilateral PECS II block, or bilateral sham fascial plane injections (placebo comparator). All participants received the same standardized postoperative systemic analgesic regimen. To preserve allocation concealment and blinding, an investigator not involved in patient management prepared identical coded syringes according to the randomization sequence. The physician performing the ultrasound-guided procedures was unaware of syringe contents. All participants underwent bilateral injections at both the PECS II and SAP fascial planes; depending on group allocation, each fascial plane received either 0.25% bupivacaine or 0.9% saline. Postoperative outcome assessment was performed by investigators blinded to treatment allocation. The primary outcome was postoperative pain intensity measured using the Visual Analog Scale (VAS) at predefined time points after extubation. Secondary outcomes included cumulative opioid consumption during the first 24 postoperative hours, postoperative nausea and vomiting (PONV), and block-related complications. Additional recovery-related outcomes included duration of mechanical ventilation, time to first mobilization, and intensive care unit (ICU) length of stay. These recovery outcomes were analyzed as exploratory endpoints because ICU clinicians were not blinded and important perioperative factors influencing recovery were not systematically collected.
Interventions
PROCEDUREBilateral Serratus Anterior Plane Block
Ultrasound-guided bilateral serratus anterior plane (SAP) block performed using 20 mL of 0.25% bupivacaine on each side after ICU admission while patients remained intubated following elective coronary artery bypass grafting.
PROCEDUREBilateral PECS II Block
Ultrasound-guided bilateral PECS II block was performed using the standard two-injection technique after ICU admission while patients remained intubated following elective coronary artery bypass grafting. On each side, a total of 20 mL of 0.25% bupivacaine was injected between the pectoralis major and minor muscles and between the pectoralis minor and serratus anterior muscles.
PROCEDURESham Fascial Plane Procedure
Ultrasound-guided bilateral sham fascial plane procedure was performed after ICU admission while patients remained intubated following elective coronary artery bypass grafting. On each side, 20 mL of 0.9% saline was injected at both the PECS II and serratus anterior plane injection sites using identical coded syringes to maintain study blinding.
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The allocation sequence and coded syringes were prepared by an investigator who was not involved in intervention administration, postoperative care, or outcome assessment. Each participant had two identical-appearing syringes labelled "PECS" and "SAP." The active syringe contained bupivacaine and the other contained 0.9% saline; both syringes contained saline in the sham group. A blinded anesthesiologist performed ultrasound-guided injections in both anatomical regions for every participant and was unaware of syringe contents and allocation. Participants, ICU clinicians responsible for postoperative care, ventilator weaning and extubation, and postoperative outcome assessors were blinded. Only the investigator preparing the syringes had access to the allocation sequence.
Intervention model description
Prospective, randomized, placebo-controlled, parallel-group, double-dummy trial comparing postoperative bilateral serratus anterior plane block, PECS II block, and sham intervention in mechanically ventilated patients undergoing elective coronary artery bypass grafting.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged 20 years and older ASA physical status II-IV Scheduled for elective coronary artery bypass grafting (CABG) via median sternotomy Extubated in the intensive care unit after surgery Provided written informed consent
Exclusion criteria
Refusal to participate or inability to provide informed consent Pregnancy Known allergy or contraindication to bupivacaine or other amide local anesthetics Coagulopathy or ongoing anticoagulation precluding regional anesthesia Local infection at the planned injection site Severe hepatic or renal failure Pre-existing chronic opioid use or chronic pain requiring opioid treatment Pre-existing neurological disorders affecting pain assessment Requirement for emergency surgery or concomitant cardiac procedures other than isolated CABG Reoperation for postoperative bleeding before outcome assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity assessed using the Visual Analog Scale (VAS) | 4, 8, 12, and 24 hours after extubation | Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Assessments will be performed at 4, 8, 12, and 24 hours after extubation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea and vomiting (PONV) | Within 24 hours after surgery | The occurrence of postoperative nausea and/or vomiting will be recorded during the first 24 hours after surgery. |
| Block-related complications | During hospitalization | Block-related complications, including local anesthetic systemic toxicity, hematoma, infection, pneumothorax, vascular puncture, nerve injury, or other procedure-related adverse events, will be recorded. |
| Length of intensive care unit (ICU) stay | From ICU admission to ICU discharge (assessed up to 30 days). | Length of stay in the intensive care unit (ICU), measured in hours from ICU admission to ICU discharge. |
| Time to first mobilization | From ICU admission to first mobilization (assessed up to 7 days). | Time from ICU admission to first mobilization, measured in hours. |
| Duration of mechanical ventilation | From ICU admission to successful extubation (assessed up to 7 days). | Duration of mechanical ventilation, measured as the time from ICU admission to successful extubation, in hours. |
| Total tramadol and pethidine consumption within the first 24 postoperative hours | Within the first 24 postoperative hours | Cumulative intravenous tramadol and pethidine doses administered during the first 24 postoperative hours will be recorded and reported separately in milligrams. |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRSchool of Mdicine Department of Anesthesiology and Reanimation
Yuzuncu Yil University
Outcome results
None listed