- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07330479
Serratus Posterior Superior Intercostal Plane Block
Evaluation of the Efficacy of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block For Postoperative Analgesia in Thoracic Surgery
Background: Adequate pain control after video-assisted thoracoscopic surgery (VATS) remains a major clinical challenge. Traditional techniques such as thoracic epidural analgesia are effective but limited by potential complications. Interfascial plane blocks have recently gained interest as safer alternatives. The serratus posterior superior intercostal plane block (SPSIPB) is a novel regional anesthesia technique with potential benefits in thoracic surgery.
Objective: The purpose of this study was to evaluate the analgesic efficacy of ultrasound-guided SPSIPB compared with subcutaneous morphine administration in patients undergoing VATS.
Methods: In this prospective, randomized controlled trial, 60 patients scheduled for elective VATS were randomized into two groups: SPSIPB group (n=30) and control group receiving subcutaneous morphine (n=30). The primary outcome was postoperative pain intensity measured by the visual analog scale (VAS) at rest and during coughing. Secondary outcomes included opioid consumption, number of patient-controlled analgesia (PCA) demands, rescue analgesia requirements, and incidence of adverse effects.
Study Overview
Status
Conditions
Detailed Description
Background and Rationale:
Effective postoperative analgesia after thoracic surgery is essential to prevent pulmonary complications, enhance recovery, and improve patient satisfaction. Although thoracic epidural analgesia has traditionally been considered the gold standard, its use is limited due to potential complications such as hypotension, urinary retention, and technical difficulties. With the increased use of minimally invasive thoracic procedures, including video-assisted thoracoscopic surgery (VATS), safer and less invasive analgesic techniques are being explored.
The serratus posterior superior intercostal plane block (SPSIPB) is a newly described regional anesthesia technique that targets the posterior thoracic intercostal nerves. Preliminary evidence suggests that SPSIPB may provide effective postoperative analgesia while minimizing procedure-related risks.
Objective:
The aim of this study was to evaluate the analgesic efficacy and safety of ultrasound-guided SPSIPB compared with subcutaneous morphine injection for postoperative pain management in patients undergoing VATS.
Study Design:
This was a prospective, randomized controlled, single-center clinical trial conducted at Gaziantep University Faculty of Medicine, Department of Anesthesiology. Sixty patients scheduled for elective VATS under general anesthesia were enrolled. After obtaining informed consent, patients were randomly allocated into two groups:
SPSIPB Group (n = 30): Patients received an ultrasound-guided serratus posterior superior intercostal plane block with 20 mL of local anesthetic at the end of surgery.
Control Group (n = 30): Patients received subcutaneous morphine injection according to institutional standard practice.
Outcome Measures:
The primary outcome was postoperative pain intensity assessed by the Visual Analog Scale (VAS) at rest and during coughing at multiple time points within the first 24 hours after surgery. Secondary outcomes included total opioid consumption within 24 hours, the number of patient-controlled analgesia (PCA) demands, the need for rescue analgesia, and the incidence of adverse events such as nausea, vomiting, respiratory depression, or block-related complications.
Significance:
This study will contribute to the growing evidence on interfascial plane blocks in thoracic surgery. If proven effective, SPSIPB may serve as a safe and valuable alternative to conventional analgesic methods, reducing opioid consumption and related side effects in patients undergoing VATS.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Gaziantep, Turkey (Türkiye), 27410
- Gaziantep University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 70 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective video-assisted thoracoscopic surgery (VATS) under general anesthesia
- Provision of written informed consent
Exclusion Criteria:
- Conversion to thoracotomy during surgery
- Coagulopathy or ongoing anticoagulant therapy
- Local infection at the injection site
- Known allergy to local anesthetics or morphine
- Severe cardiopulmonary disease contraindicating regional anesthesia
- Refusal to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SPSIPB Group
Patients received an ultrasound-guided SPSIPB with 20 mL local anesthetic at the end of surgery.
|
Intervention Type: Procedure (Regional Anesthesia) Name: Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) Description: A single injection of 20 mL of local anesthetic was administered under ultrasound guidance into the serratus posterior superior intercostal plane at the end of surgery.
|
|
Active Comparator: Active Comparator
Patients received a subcutaneous morphine injection according to institutional standard practice after surgery.
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Intervention Type: Drug (Morphine) Name: Subcutaneous Morphine Description: Patients received a single subcutaneous injection of morphine (dose according to institutional standard practice) after surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Intensity
Time Frame: 24 hours after surgery (measured at 0, 2, 4, 8, 16, and 24 hours)
|
Pain intensity was assessed using the Visual Analog Scale (VAS; 0 = no pain, 10 = worst pain imaginable) at rest and during coughing.
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24 hours after surgery (measured at 0, 2, 4, 8, 16, and 24 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total opioid consumption within 24 hours
Time Frame: 24 hours after surgery (cumulative from 0 to 24 hours)
|
The cumulative opioid dose administered via patient-controlled analgesia (PCA) and rescue doses was recorded.
|
24 hours after surgery (cumulative from 0 to 24 hours)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elzem Şen, Assoc. Prof, University of Gaziantep
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
- 2023/376
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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