- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07426692
Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial
This prospective randomized controlled trial was conducted to compare the effectiveness of two ultrasound-guided regional anesthesia techniques, erector spinae plane block (ESPB) and serratus posterior superior intercostal plane block (SPSIPB), with standard patient-controlled analgesia (PCA) for postoperative pain management after video-assisted thoracoscopic surgery (VATS).
Adult patients undergoing elective VATS were randomly assigned to receive ESPB, SPSIPB, or PCA alone. The primary objective was to evaluate postoperative pain intensity during the first 48 hours after surgery. Secondary outcomes included opioid consumption, rescue analgesia requirements, patient satisfaction, and postoperative complications.
Study Overview
Status
Detailed Description
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive surgical technique; however, postoperative pain remains clinically significant and may delay recovery and increase opioid consumption. Ultrasound-guided fascial plane blocks have been increasingly incorporated into multimodal analgesia strategies in thoracic surgery.
This single-center, prospective, randomized controlled study included adult patients aged 18-75 years with ASA physical status I-III who were scheduled for elective VATS. After obtaining written informed consent and ethics committee approval, patients were randomly assigned in a parallel design to one of three groups: ESPB group, SPSIPB group, or control group receiving morphine patient-controlled analgesia (PCA) alone.
Both ESPB and SPSIPB were performed preoperatively under ultrasound guidance by an experienced anesthesiologist prior to induction of general anesthesia. Standardized general anesthesia and postoperative analgesia protocols were applied to all patients.
The primary outcome was postoperative pain intensity assessed using the Numeric Rating Scale (NRS, 0-10) at predefined time points up to 48 hours postoperatively. Secondary outcomes included cumulative morphine consumption, number of morphine demands, rescue analgesia requirements, patient satisfaction, and opioid-related adverse events.
The study aimed to determine whether SPSIPB provides analgesic efficacy comparable to ESPB and whether both regional techniques reduce opioid consumption compared with PCA alone.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Marmara University Faculty of Medicine Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 75 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective video-assisted thoracoscopic surgery (VATS)
- Ability to understand and use patient-controlled analgesia device
- Provided written informed consent
Exclusion Criteria:
- - Coagulation disorders or current anticoagulant therapy
- Infection at the block application site
- Known allergy to local anesthetic agents
- Anatomical abnormalities interfering with ultrasound-guided block
- Severe cardiac, renal, or hepatic failure
- Neurological or cognitive impairment preventing reliable pain assessment
- Emergency surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ESPB Group
Patients received ultrasound-guided erector spinae plane block prior to induction of general anesthesia in addition to standard postoperative PCA.
|
Ultrasound-guided erector spinae plane block performed preoperatively using local anesthetic.
|
|
Experimental: SPSIPB Group
Patients received ultrasound-guided serratus posterior superior intercostal plane block prior to induction of general anesthesia in addition to standard postoperative PCA.
|
Ultrasound-guided serratus posterior superior intercostal plane block performed preoperatively using local anesthetic.
|
|
Active Comparator: PCA Group
Patients received standard postoperative morphine patient-controlled analgesia without regional block.
|
Intravenous morphine administered via patient-controlled analgesia device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity
Time Frame: 0 to 48 hours postoperatively
|
Postoperative pain assessed using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain.
|
0 to 48 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative morphine consumption
Time Frame: 0 to 48 hours postoperatively
|
Total amount of intravenous morphine administered via patient-controlled analgesia device.
|
0 to 48 hours postoperatively
|
|
Rescue analgesia requirements
Time Frame: 12 hours postoperatively
|
12 hours postoperatively
|
Collaborators and Investigators
Sponsor
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
- 09.2025.25-0167
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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