- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05958823
Effects of Serratus Anterior Plane Block (SAP), Pectoral Nerve Blocks (PECS I-II), and Standard Systemic Analgesia on Early Postoperative Recovery After Coronary Artery Bypass Grafting
A Prospective, Randomized Controlled Trial Comparing Serratus Anterior Plane Block (SAP), Pectoral Nerve Blocks (PECS I-II), and Standard Systemic Analgesia on Mechanical Ventilation Duration and Postoperative Recovery After Coronary Artery Bypass Grafting
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Turkey
-
Van, Turkey, Turkey (Türkiye), 65100
- Van Yüzüncü Yil University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group S - Serratus Anterior Plane Block
Patients received an ultrasound-guided serratus anterior plane (SAP) block with 30 mL of 0.25% bupivacaine within the first 30 minutes after ICU admission in addition to standardized systemic analgesia.
|
Serratus anterior plane block
|
|
Experimental: Group P - Pectoral Nerve Block (PECS I-II)
Patients received ultrasound-guided PECS I-II block with a total of 30 mL of 0.25% bupivacaine within the first 30 minutes after ICU admission in addition to standardized systemic analgesia.
|
PECS I-II
|
|
Active Comparator: Group C - Standard Systemic Analgesia
Patients received standardized multimodal systemic analgesia without any regional block.
Postoperative analgesia consisted of scheduled intravenous paracetamol and rescue opioid administration as needed.
|
Standard postoperative multimodal systemic analgesia without regional nerve block.
Postoperative analgesia includes scheduled intravenous paracetamol and rescue opioid administration as needed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of Mechanical Ventilation
Time Frame: Within the first 24 postoperative hours
|
Time (in hours) from ICU admission to successful extubation.
|
Within the first 24 postoperative hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of Intensive Care Unit (ICU) Stay
Time Frame: 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.
|
Assessed once at the time of ICU discharge, measured as total hours from ICU admission to ICU discharge (expected within 30 postoperative days).
|
|
Postoperative Pain Intensity at Rest (VAS)
Time Frame: 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.
|
Assessed at 0, 4, 8, 12, and 24 hours after extubation within the first 24 hours post-extubation.
|
|
Total Rescue Opioid Consumption (Morphine Equivalents)
Time Frame: 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.
|
Within the first 24 hours after extubation
|
|
Time to First Mobilization
Time Frame: 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.
|
Assessed once when first active sitting at bedside is achieved, within 48 hours after ICU admission.
|
|
Postoperative Nausea and Vomiting (PONV)
Time Frame: 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.
|
Assessed at 0-24, 24-48, and 48-72 hours after extubation during postoperative ICU and ward follow-up.
|
|
Length of Hospital Stay
Time Frame: 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.
|
Assessed once at hospital discharge, measured as total days from date of surgery to hospital discharge (expected within 30 postoperative days).
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: School of Medicine Department of Anesthesiology and Reanimation, Yuzuncu Yil University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22.05.2023-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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