- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07524673
Comprasion of SPSIP and Rhomboid Intercostal Plan Blocks on VATS
Comparison of the Analgesic Efficacy of Rhomboid Intercostal Plane Block and Serratus Posterior Superior Intercostal Plane Block on Postoperative Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients were randomly allocated into two groups: RIB and SPSIPB. All patients received postoperative paracetamol and dexketoprofen, and intravenous tramadol hydrochloride was administered via patient-controlled analgesia. Postoperative static and dynamic NRS scores, total tramadol consumption, side effects, and the need for additional analgesia were monitored and recorded at regular intervals. Primary outcome was NRS scores and secondary outcome was total tramadol consumption.
Block Techniques
All blocks were performed following surgical closure, prior to extubation, with the patient in lateral decubitus and the skin prepared with 10% povidone-iodine.
RIB:Rhomboid intercostal plane block procedure is performed using a high-frequency linear ultrasound probe. First, the rhomboid and intercostal muscles are located in the area called the auscultation triangle, at the level of thoracic 4-5 o'clock. A needle, visible on ultrasound, is advanced between the rhomboid and intercostal muscles using an in-plane technique. After aspiration is performed to ensure no blood or air is present, a total of 30 ml of 0.25% bupivacaine will be injected between the two muscle planes. The rhomboid intercostal plane block creates sensory paresthesia (sensory numbness) in a dermatomal region between T3 and T9 o'clock.
SPSIPB: The USG probe was placed 2-3 cm medial to the scapular spine to visualize the trapezius, rhomboid major, and serratus posterior superior muscles. At the level of the 2nd-3rd ribs, a needle was advanced into the plane between the serratus posterior superior muscle and the rib. After confirming negative aspiration, 30 mL of 0.25% bupivacaine was injected.
All blocks were performed unilaterally, targeting the surgical hemithorax.
Postoperative Analgesia and Assessments
Twenty minutes before extubation, all patients received 1 g IV paracetamol and 50 mg IV dexketoprofen. In the recovery room, patient-controlled analgesia (PCA) with IV tramadol hydrochloride was initiated (4 mg/mL concentration, 10 mg bolus, 20-minute lockout, maximum 3 boluses/hour).
Postoperative NRS scores (static at rest and dynamic during movement or coughing) were recorded at 0, 1, 2, 6, 12, 18, and 24 hours. The first NRS assessment (0 hour) was performed when the patient achieved an Aldrete score of 9. If NRS ≥ 4, an additional 50 mg IV tramadol was administered. Additional analgesic consumption was recorded. Side effects such as nausea, vomiting, and pruritus were documented.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: OĞUZ GÜNDOĞDU
- Phone Number: +905545945469
- Email: droguzgundogdu@gmail.com
Study Contact Backup
- Name: Melike Avşar
- Phone Number: +905309324606
- Email: melikekarabork@gmail.com
Study Locations
-
-
Merkez
-
Sivas, Merkez, Turkey (Türkiye), 58000
- Completed
- Sivas Cumhuriyet University
-
-
Sivas
-
Sivas, Sivas, Turkey (Türkiye), 58140
- Recruiting
- Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
-
Contact:
- Oğuz Gündoğdu
- Phone Number: +905544595469
- Email: droguzgundogdu@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Forty adult patients scheduled for elective wedge resection or biopsy under VATS, classified as American Society of Anesthesiologists (ASA) physical status I-III, were enrolled after providing written informed consent.
Exclusion Criteria:
- ASA class IV or higher,
- morbid obesity (BMI > 40 kg/m²),
- body weight ≤ 50 kg,
- skin infection at the block site,
- refusal to participate,
- inability to cooperate during postoperative pain assessment,
- conversion to open surgery,
- preexisting pain,
- known allergy to any study medication,
- coagulopathy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: SPSIP BLOCK
Arm Description: The USG probe was placed 2-3 cm medial to the scapular spine to visualize the trapezius, rhomboid major, and serratus posterior superior muscles.
At the level of the 2nd-3rd ribs, a needle was advanced into the plane between the serratus posterior superior muscle and the rib.
After confirming negative aspiration, 30 mL of 0.25% bupivacaine was injected.
The block was performed unilaterally, targeting the surgical hemithorax.
|
The USG probe was placed 2-3 cm medial to the scapular spine to visualize the trapezius, rhomboid major, and serratus posterior superior muscles.
At the level of the 2nd-3rd ribs, a needle was advanced into the plane between the serratus posterior superior muscle and the rib.
After confirming negative aspiration, 30 mL of 0.25% bupivacaine was injected.
The block was performed unilaterally, targeting the surgical hemithorax.
|
|
Active Comparator: RIB BLOCK
Arm Description:Rhomboid intercostal plane block procedure, 10% povidone-iodine will be used for skin cleansing.
The procedure is performed using a high-frequency linear ultrasound probe.
First, the rhomboid and intercostal muscles are located in the area called the auscultation triangle, at the level of thoracic 4-5 o'clock.
A needle, visible on ultrasound, is advanced between the rhomboid and intercostal muscles using an in-plane technique.
After aspiration is performed to ensure no blood or air is present, a total of 30 ml of 0.25% bupivacaine will be injected between the two muscle planes.
The rhomboid intercostal plane block creates sensory paresthesia (sensory numbness) in a dermatomal region between T3 and T9 o'clock.
|
30 mL of 0.25% bupivacaine was injected deep to the rhomboid intercostal spinal block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NUMERICAL RATING SCORE(NRS)
Time Frame: postoperative 24 hours
|
Numerical rating scale is used for pain assessment.
The scores of the numerical rating scale changes between 0 to 10 points.
10 points mean "the most severe pain that the patient ever had".
0 point means "there is no pain."
Higher scores mean worse outcome.
|
postoperative 24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: OĞUZ GÜNDOĞDU, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-04/01
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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