- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07729488
ESPB Versus SPSIPB for Quality of Recovery After Video-Assisted Thoracoscopic Surgery
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block for Quality of Recovery After Video-Assisted Thoracoscopic Surgery: A Randomized Double-Blind Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Video-assisted thoracoscopic surgery (VATS) has become the preferred surgical approach for many thoracic procedures because of its minimally invasive nature. Nevertheless, patients frequently experience moderate to severe postoperative pain, which may impair respiratory function, delay mobilization, prolong hospitalization, and negatively affect overall recovery. Effective multimodal analgesia is therefore essential for optimizing postoperative outcomes.
Ultrasound-guided erector spinae plane block (ESPB) and serratus posterior superior intercostal plane block (SPSIPB) are interfascial plane blocks that have demonstrated promising analgesic efficacy in thoracic surgery. Although both techniques are increasingly used in clinical practice, evidence directly comparing their effects on postoperative quality of recovery following VATS is limited.
This prospective, randomized, double-blind, parallel-group clinical trial will enroll 128 adult patients (18-70 years, ASA physical status I-III) undergoing elective VATS. Participants will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided ESPB or ultrasound-guided SPSIPB before surgery.
The primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 hours after surgery. Secondary outcomes include postoperative pain scores at rest and during coughing, cumulative 24-hour tramadol consumption, time to first rescue analgesia, rescue analgesic requirement, postoperative nausea and vomiting, sedation level, patient satisfaction, length of hospital stay, block-related complications, perioperative hemodynamic variables, and additional analgesic requirements.
The results of this study are expected to provide high-quality evidence regarding the comparative effectiveness of ESPB and SPSIPB in improving postoperative recovery and analgesic outcomes after VATS and may contribute to optimizing regional analgesia strategies for thoracic surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fatma Acil, M.D.
- Phone Number: +905337225225
- Email: acilfatma@gmail.com
Study Locations
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-
Outside of the US
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Diyarbakır, Outside of the US, Turkey (Türkiye), 21070
- Fatma Acil
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Turkey
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Diyarbakır, Turkey, Turkey (Türkiye), 21070
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18-85 years.
- ASA physical status I-III.
- Scheduled for elective VATS under general anesthesia.
- Able to understand and complete the QoR-15 questionnaire.
- Written informed consent provided.
Exclusion Criteria:
- Refusal to participate or inability to provide written informed consent.
- Known allergy or contraindication to bupivacaine, paracetamol, dexketoprofen, or tramadol.
- Infection at the planned block injection site.
- Coagulopathy or ongoing anticoagulant therapy precluding regional anesthesia.
- Severe hepatic or renal insufficiency.
- Chronic opioid use or chronic pain requiring regular analgesic treatment.
- Previous thoracic surgery on the operative side.
- Pregnancy or breastfeeding.
- Cognitive impairment, psychiatric illness, or language barrier preventing completion of the QoR-15 questionnaire.
- Body mass index (BMI) >35 kg/m².
- Conversion from VATS to thoracotomy.
- Failed or incomplete regional block.
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: Ultrasound-Guided Erector Spinae Plane Block (ESPB)
An ultrasound-guided erector spinae plane block (ESPB) will be performed before induction of general anesthesia using 30 mL of 0.25% bupivacaine for postoperative analgesia in patients undergoing elective video-assisted thoracoscopic surgery (VATS).
|
An ultrasound-guided erector spinae plane block will be performed preoperatively for postoperative analgesia in patients undergoing elective video-assisted thoracoscopic surgery.
The block will be performed using the standardized study protocol.
Other Names:
|
|
Experimental: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block
An ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) will be performed before induction of general anesthesia using 30 mL of 0.25% bupivacaine for postoperative analgesia in patients undergoing elective video-assisted thoracoscopic surgery (VATS).
|
An ultrasound-guided serratus posterior superior intercostal plane block will be performed preoperatively for postoperative analgesia in patients undergoing elective video-assisted thoracoscopic surgery.
The block will be performed using the standardized study protocol.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Recovery-15 (QoR-15) Score
Time Frame: 24 hours after surgery
|
Postoperative quality of recovery will be assessed using the validated Turkish version of the Quality of Recovery-15 questionnaire.
The total score ranges from 0 to 150, with higher scores indicating better recovery.
The preoperative QoR-15 score will be recorded as a baseline measurement and considered in the analysis of the postoperative 24-hour score.
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24 hours after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain at Rest
Time Frame: 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery.
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Postoperative pain intensity at rest will be assessed using an 11-point Numerical Rating Scale (NRS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
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30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery.
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Postoperative Pain Intensity During Coughing
Time Frame: 30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery.
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Postoperative pain intensity during coughing will be assessed using an 11-point Numerical Rating Scale (NRS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
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30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery.
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Time to First Rescue Analgesia
Time Frame: During the first 24 hours after surgery
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The time from arrival in the post-anesthesia care unit (PACU) to the first administration of rescue analgesia will be recorded in minutes.
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During the first 24 hours after surgery
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Cumulative Postoperative Tramadol Consumption
Time Frame: During the first 24 hours after surgery
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The total amount of tramadol administered for postoperative rescue analgesia during the first 24 hours after surgery will be recorded in milligrams (mg).
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During the first 24 hours after surgery
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Requirement for Rescue Analgesia
Time Frame: During the first 24 hours after surgery
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The proportion of participants requiring at least one dose of rescue analgesia during the first 24 hours after surgery will be recorded.
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During the first 24 hours after surgery
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Postoperative Nausea and Vomiting Impact Score
Time Frame: During the first 24 hours after surgery
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Postoperative nausea and vomiting will be assessed using the Simplified Postoperative Nausea and Vomiting Impact Scale.
The scale combines the number of vomiting episodes and the perceived impact of nausea on recovery, with a total score ranging from 0 to 6. Higher scores indicate a greater impact of postoperative nausea and vomiting, and a score of 5 or greater indicates clinically important PONV.
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During the first 24 hours after surgery
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Patient Satisfaction With Postoperative Analgesia
Time Frame: 24 hours after surgery
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Patient satisfaction with postoperative pain management will be assessed using a 5-point Likert scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, and 5 = very satisfied.
Higher scores indicate greater patient satisfaction.
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24 hours after surgery
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Postoperative Length of Hospital Stay
Time Frame: From surgery until hospital discharge (up to 30 days)
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Postoperative length of hospital stay will be recorded as the number of days from surgery until hospital discharge.
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From surgery until hospital discharge (up to 30 days)
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Incidence of Block-Related Complications
Time Frame: From block performance until hospital discharge (up to 30 days)
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The incidence of block-related complications, including local anesthetic systemic toxicity, pneumothorax, hematoma, infection, vascular puncture, and other procedure-related adverse events, will be recorded.
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From block performance until hospital discharge (up to 30 days)
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Collaborators and Investigators
Investigators
- Principal Investigator: Fatma Acil, M.D., Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07/20/2026-xxx
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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