Postoperative Complications, Postoperative Pain, Side Effect
Conditions
Brief summary
The effects of anterior chest wall blocks (PECS and SAP will be used in this study) performed for postoperative analgesia on pain scores (to be checked with visual analogue scale (VAS), opioid consumption, length of hospital stay, mobilization time, side effects and complications in the postoperative period will be examined.
Detailed description
Patients meeting the inclusion criteria and providing written informed consent were randomly assigned to one of three parallel study groups using a computer-generated randomization sequence prepared by an independent investigator. Participants were allocated in a 1:1:1 ratio to: Group S (Serratus Anterior Plane Block - SAP): Following coronary artery bypass grafting (CABG), patients were transferred to the cardiovascular intensive care unit (ICU). Within the first 30 minutes after ICU admission, an ultrasound-guided serratus anterior plane (SAP) block was performed using an 8-cm peripheral block needle. After appropriate aseptic preparation of the anterior chest wall, 30 mL of 0.25% bupivacaine was injected into the fascial plane either superficial or deep to the serratus anterior muscle at the level of the fourth rib. All patients additionally received standardized multimodal systemic analgesia. Group P (Pectoral Nerve Block - PECS I-II): After transfer to the ICU, patients received an ultrasound-guided PECS I-II block within the first 30 minutes. Following sterile preparation, 15 mL of 0.25% bupivacaine was injected into the interpectoral plane (between pectoralis major and minor muscles) for PECS I, and an additional 15 mL was injected into the plane between pectoralis minor and serratus anterior muscles for PECS II, totaling 30 mL. Standardized systemic analgesia was also administered. Group C (Control - Standard Systemic Analgesia): Patients received standardized multimodal systemic postoperative analgesia without any regional nerve block. Postoperative analgesia included scheduled intravenous paracetamol and rescue opioid administration as needed. Participants and outcome assessors were blinded to group allocation. The anesthesiologist performing the regional block was not blinded. ICU clinicians responsible for extubation decisions were unaware of treatment allocation. The study primarily evaluated the duration of mechanical ventilation (time from ICU admission to successful extubation within the first 24 postoperative hours). Secondary outcomes included ICU length of stay, postoperative pain intensity (VAS at 0, 4, 8, 12, and 24 hours post-extubation), total rescue opioid consumption (morphine equivalents), time to first mobilization, postoperative nausea and vomiting (PONV), and length of hospital stay.
Interventions
PROCEDURESerratus anterior plane block
Serratus anterior plane block
PROCEDUREPECS I-II
PECS I-II
Standard postoperative multimodal systemic analgesia without regional nerve block. Postoperative analgesia includes scheduled intravenous paracetamol and rescue opioid administration as needed.
Sponsors
Yuzuncu Yil University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors were blinded to group allocation. The anesthesiologist performing the regional block was not blinded. ICU clinicians responsible for extubation decisions were unaware of treatment allocation.
Intervention model description
Prospective, randomized, parallel-group, controlled clinical trial with three arms.
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Agreeing to participate in the study, * 20-65 years old * ASA I-II-III * Open heart surgery
Exclusion criteria
* Refusal to participate in the study * 20 years old, over 65 years old * Pregnancy * Presence of bleeding diathesis * Liver or kidney failure * Receiving effective treatment on immunity * Immune suppressed * Those with BMI ≥30
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Mechanical Ventilation | Within the first 24 postoperative hours | Time (in hours) from ICU admission to successful extubation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Intensive Care Unit (ICU) Stay | Assessed once at the time of ICU discharge, measured as total hours from ICU admission to ICU discharge (expected within 30 postoperative days). | Total duration of ICU stay measured in hours from ICU admission to ICU discharge. |
| Postoperative Pain Intensity at Rest (VAS) | Assessed at 0, 4, 8, 12, and 24 hours after extubation within the first 24 hours post-extubation. | Pain intensity measured using the Visual Analog Scale (VAS; 0-10 cm, 0=no pain and 10=worst imaginable pain). Assessments performed after extubation when adequate consciousness was confirmed. |
| Total Rescue Opioid Consumption (Morphine Equivalents) | Within the first 24 hours after extubation | Total rescue analgesic requirement within 24 hours, calculated by converting administered tramadol and pethidine doses to intravenous morphine equivalents using predefined equianalgesic ratios. |
| Time to First Mobilization | Assessed once when first active sitting at bedside is achieved, within 48 hours after ICU admission. | Time (in hours) from ICU admission to the first active sitting at the bedside with assistance under ICU staff supervision. |
| Postoperative Nausea and Vomiting (PONV) | Assessed at 0-24, 24-48, and 48-72 hours after extubation during postoperative ICU and ward follow-up. | Presence of nausea and/or vomiting recorded as a binary outcome (present/absent) during routine assessments and on patient report. |
| Length of Hospital Stay | Assessed once at hospital discharge, measured as total days from date of surgery to hospital discharge (expected within 30 postoperative days). | Total duration of hospital stay measured in days from the day of surgery to hospital discharge. |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRSchool of Medicine Department of Anesthesiology and Reanimation
Yuzuncu Yil University
Outcome results
None listed