- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07467291
SPSIP Block vs SAP Block for Post-VATS Pain
Comparison of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block for Pain Management Following Video-Assisted Thoracoscopic Surgery
Comparison of Superior Serratus Posterior Intercostal Plane Block and Serratus Anterior Plane Block for Pain Management Following Video-Assisted Thoracoscopic Surgery: A Randomized Prospective Study
Introduction Video-assisted thoracoscopic surgery (VATS) is associated with lower postoperative pain, shorter hospital stays, and better preservation of pulmonary function compared with conventional thoracotomy, owing to its minimally invasive nature. Although VATS was initially performed using a multi-port technique, it has evolved into a single-port approach, reflecting advances in surgical techniques and equipment. In Uniportal VATS, limiting surgical trauma to a single intercostal space may reduce the risk of chronic postoperative pain by decreasing intercostal nerve damage.
Because inadequate pain control after VATS may predispose patients to developing chronic post-thoracotomy pain syndrome (PTPS), effective postoperative analgesia is critically important. Therefore, regional analgesic techniques are recommended as part of multimodal analgesia. PROSPECT guidelines do not recommend the routine use of thoracic epidural analgesia for VATS, despite its effectiveness, because of its invasiveness; instead, they emphasize peripheral blocks such as paravertebral block and erector spinae plane block.
Although not included among first-line analgesic interventions in PROSPECT guidelines, the serratus anterior plane block (SAPB) is a widely used and well-established technique in thoracic surgery. In addition, the superior serratus posterior intercostal plane block (SPSIPB) is gaining attention in VATS surgery because of its analgesic effect covering the C3-T10 dermatomes.
Although there are studies in the literature comparing SAPB with different regional techniques, there is no randomized controlled trial directly comparing it with SPSIPB. Therefore, this planned study aimed to evaluate whether SPSIPB is noninferior to SAPB for postoperative analgesia and to compare the postoperative analgesic efficacy of the two techniques performed under ultrasound guidance.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: AHMET AKSU
- Phone Number: +90 530 349 38 96
- Email: aaksu@firat.edu.tr
Study Locations
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-
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Elâzığ, Turkey (Türkiye), 23100
- Recruiting
- Fırat University Faculty of Medicine Hospital
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Contact:
- İsmail Demirel, Professor
- Phone Number: +90 533 466 88 66
- Email: ismaildemirel23@firat.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged 18-65 years,
- with American Society of Anesthesiologists (ASA) physical status classification I-III,
- Body Mass Index (BMI) < 35 kg/m²,
- and who read and signed the informed consent form were included.
Exclusion Criteria:
- inability to communicate in Turkish, refusal to consent,
- inability to use the numerical pain rating scale (NRS),
- allergy to local anesthetics or study-specific analgesics;
- pregnancy or breastfeeding;
- uncontrolled anxiety or substance dependence;
- history of thoracic surgery,
- trauma,
- neuromuscular or peripheral nerve disorders;
- diabetes mellitus,
- hepatic or renal insufficiency,
- coagulation disorders;
- chronic opioid or steroid use;
- widespread pain;
- anticoagulant therapy;
- infection at the block application site;
- early termination of surgery;
- absence of planned postoperative extubation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Serratus Anterior Plane Block (SAPB) group
|
The block was performed with the patient in the lateral decubitus position.
Ultrasound-guided SAPB was performed by the same anesthesiologist with over three years of experience in ultrasound-guided regional anesthesia, using a high-frequency linear probe (LOGIQ e Ultrasound, GE HealthCare, United States).
The probe was positioned parallel to the mid-axillary line, and the ribs were readily identified as hyperechogenic lines.
The fifth rib was identified in the mid-axillary line.
Using an in-plane technique, the needle was placed in the myofascial plane between the serratus anterior muscle and the fifth rib, and 20 mL of 0.25% ropivacaine was injected.
The needle was then withdrawn until it reached the myofascial plane formed by the serratus anterior and latissimus dorsi muscles, and a hydrodissection technique was used to confirm that the needle was located in the intended myofascial space.
After negative aspiration, 10 mL of 0.25% ropivacaine was injected.
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|
Active Comparator: Serratus posterior superior intercostal plane block Group
The procedure was performed with the patient in the lateral decubitus position.
After a slight lateral displacement of the scapula, the scapular spine was visualized with ultrasound, and the probe was moved medially.
After locating the tip of the scapular spine, the probe was placed sagittally at the superior angle of the scapula, and the third rib was visualized.
The block needle was advanced craniocaudally and placed between the posterior superior serratus muscle and the third rib.
Hydrodissection was performed with an injection of 2 mL of saline to confirm block needle placement.
After confirming the block site, 30 mL of 0.25% bupivacaine was injected.
|
The procedure was performed with the patient in the lateral decubitus position.
After a slight lateral displacement of the scapula, the scapular spine was visualized with ultrasound, and the probe was moved medially.
After locating the tip of the scapular spine, the probe was placed sagittally at the superior angle of the scapula, and the third rib was visualized.
The block needle was advanced craniocaudally and placed between the posterior superior serratus muscle and the third rib.
Hydrodissection was performed with an injection of 2 mL of saline to confirm block needle placement.
After confirming the block site, 30 mL of 0.25% bupivacaine was injected.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To determine the effectiveness of ultrasound-guided SPSIP block versus SAP block after VATS using postoperative NRS pain scores.
Time Frame: NRS scores will be assessed at 1, 6, 12, 18, and 24 hours postoperatively.
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The NRS score is based on the patient rating their pain on a scale from 0 to 10. Zero indicates no pain, while 10 indicates the most severe pain possible.
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NRS scores will be assessed at 1, 6, 12, 18, and 24 hours postoperatively.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
QoR-15 recovery score
Time Frame: up to 48 hours
|
The QoR-15 (Quality of Recovery-15) scale is a patient-reported outcome questionnaire used to evaluate the quality of postoperative recovery.
The QoR-15 consists of 15 items assessing five domains: pain, physical comfort, physical independence, psychological support, and emotional state.
The total score ranges from 0 to 150, with higher scores indicating a better quality of recovery.
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up to 48 hours
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time to first rescue analgesia
Time Frame: up to 48 hours
|
the time to first rescue analgesia (tramadol 0.5 mg/kg), defined as the time interval between recovery from anesthesia and the administration of the first analgesic dose (expressed in hours), was recorded.
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up to 48 hours
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The total amount of rescue analgesic consumption
Time Frame: up to 24 hours
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The total amount of rescue analgesic consumption within the first 24 postoperative hours (mg) was also documented.
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up to 24 hours
|
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the incidence of block-related complications.
Time Frame: up to 48 hours
|
block-related complications such as hematoma, paralysis, hypotension or other adverse events were recorded.
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up to 48 hours
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Collaborators and Investigators
Sponsor
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
- 43757
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
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