- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07232940
ESP vs SPSIP Block in VATS Analgesia
Comparison of the Effects of Ultrasound-Guided Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia Management in Patients Undergoing Video-Assisted Thoracoscopic Surgery
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive procedure performed through small thoracic incisions, but postoperative pain remains significant due to tissue and rib trauma. Poorly controlled pain may lead to chronic postoperative pain; therefore, optimal analgesia is essential.
According to PROSPECT guidelines, erector spinae plane block (ESPB) or paravertebral block (PVB) are recommended for VATS. The recently defined serratus posterior superior intercostal plane block (SPSIPB) provides analgesia between C3-T10 levels, but its efficacy compared with ESPB has not been studied.
This study aims to compare postoperative analgesic efficacy and patient satisfaction between ESPB and SPSIPB in VATS patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive procedure performed through small thoracic incisions, but postoperative pain remains significant due to tissue and rib trauma. Poorly controlled pain may lead to chronic postoperative pain; therefore, optimal analgesia is essential.
According to PROSPECT guidelines, erector spinae plane block (ESPB) or paravertebral block (PVB) are recommended for VATS. The recently defined serratus posterior superior intercostal plane block (SPSIPB) provides analgesia between C3-T10 levels, but its efficacy compared with ESPB has not been studied.
This study aims to compare postoperative analgesic efficacy and patient satisfaction between ESPB and SPSIPB in VATS patients.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: emre ulusoy
- Phone Number: +905379492799
- Email: emreulusoy36@gmail.com
Study Contact Backup
- Name: Eralp Çevikkalp
- Phone Number: +905054554875
- Email: eralpcevikkalp@hotmail.com
Study Locations
-
-
Nilüfer
-
Bursa, Nilüfer, Turkey (Türkiye), 16110
- Recruiting
- Bursa City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18-65 years with ASA physical status I-III who will undergo elective video-assisted thoracoscopic surgery (VATS) will be included.
Exclusion Criteria:
- Patients who do not consent to participate in the study
Patients with coagulopathy
Patients with a history of local anesthetic allergy or toxicity
Patients with hepatic or renal failure
Patients with uncontrolled diabetes
Patients with uncontrolled hypertension
Mentally disabled patients
Patients receiving chronic pain treatment (opioid users)
Patients using antidepressant medication
Patients with neuropathic pain
Mentally disabled patients
Presence of infection at the injection site
Pregnant or breastfeeding women, or those with suspected pregnancy
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 |
|---|---|
|
Active Comparator: Erector spinae plane block
|
A high-frequency linear ultrasound probe (GE ML6-15-D Matrix Linear) will be covered with a sterile sheath.
At the T5 vertebral level, the erector spinae muscle layers and the transverse process of the T5 vertebra, located immediately beneath them, will be identified.
After confirming the transverse process, 30 mL of 0.25% bupivacaine (Buvicaine 0.5%®, Polifarma, Tekirdağ, Türkiye) containing 7.5 µg epinephrine (1:200,000) (Adrenalin Bas Galen®; Galen, İstanbul, Türkiye) will be administered as the local anesthetic solution.
|
|
Active Comparator: Serratus posterior superior intercostal plane block (SPSIPB)
|
A high-frequency linear ultrasound probe (GE ML6-15-D Matrix Linear) will be covered with a sterile sheath, and the T3 level will be identified just above the medial border of the scapula.
After visualizing the trapezius, rhomboid major, and serratus posterior superior muscles (from superficial to deep), 30 mL of 0.25% bupivacaine (Buvicaine 0.5%®, Polifarma, Tekirdağ, Türkiye) containing 7.5 µg epinephrine (1:200,000) (Adrenalin Bas Galen®; Galen, İstanbul, Türkiye) will be administered as the local anesthetic solution.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
opioid consumption
Time Frame: 0, 2, 4, 8, 16 and 24 hours
|
Tramadol will be prepared as 5mg/ml and patient-controlled analgesia will be administered without basal infusion, with a locking time of 20 minutes and a bolus dose of 10mg.
|
0, 2, 4, 8, 16 and 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")
Time Frame: 0, 2, 4, 8, 16 and 24 hours
|
Postoperative 24 hours period.
Patients' pain scores will be questioned at 0, 2, 4, 8, 16 and 24 hours.
|
0, 2, 4, 8, 16 and 24 hours
|
|
Global recovery scoring system (patient satisfaction scale)- QoR-15
Time Frame: The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.
|
Researchers will use the Turkish version of the Quality Improvement Survey/QoR-15.
PART A: Participants will be asked by researchers how they felt in the last 24 hours.(0
to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent]) 1. Able to breathe easily 2. Been able to enjoy food 3. Feeling rested 4. Have had a good sleep 5. Able to look after personal toilet and hygiene unaided 6. Able to communicate with 7. Getting support from hospital doctors and nurses 8. Able to return to work or usual home activities 9. Feeling comfortable and in control 10.
Having a feeling of general well-being PART B Participants will be asked by the researchers whether they have experienced any of the following in the last 24 hours.
(10 to 0, where: 10 = none of the time [excellent] and 0 = all of the time [poor]) 11.
Moderate pain 12. Severe pain 13.
Nausea or vomiting 14.
Feeling worried or anxious 15.
Feeling sad or depressed
|
The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.
|
|
Brief Pain Inventory
Time Frame: postoperative third month
|
Brief Pain Inventory (BPI-Short Form) At the postoperative third month, patients will be contacted by phone, and chronic pain will be assessed using the Brief Pain Inventory - Short Form (BPI-SF). The BPI-SF consists of two main components: Pain Severity Score (0-10): Four numeric rating items evaluating worst, least, average, and current pain. Higher scores indicate more severe pain. Pain Interference Score (0-10): Seven numeric rating items evaluating interference with general activity, mood, walking ability, normal work, sleep, relations with others, and enjoyment of life. Higher scores indicate greater interference with daily activities. |
postoperative third month
|
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: On the morning of surgery and at the 3rd postoperative month
|
The Hospital Anxiety and Depression Scale (HADS) was administered preoperatively and at the 3rd postoperative month. The change between these two time points will be included in the analysis. HADS consists of 14 items, divided into two subscales: HADS-Anxiety (HADS-A): 7 items HADS-Depression (HADS-D): 7 items Each item is scored on a 0-3 Likert scale, resulting in: HADS-A total score range: 0-21 HADS-D total score range: 0-21 Higher scores indicate worse anxiety or worse depression. |
On the morning of surgery and at the 3rd postoperative month
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Steinthorsdottir KJ, Wildgaard L, Hansen HJ, Petersen RH, Wildgaard K. Regional analgesia for video-assisted thoracic surgery: a systematic review. Eur J Cardiothorac Surg. 2014 Jun;45(6):959-66. doi: 10.1093/ejcts/ezt525. Epub 2013 Nov 27.
- Mehta S, Jen TTH, Hamilton DL. Regional analgesia for acute pain relief after open thoracotomy and video-assisted thoracoscopic surgery. BJA Educ. 2023 Aug;23(8):295-303. doi: 10.1016/j.bjae.2023.05.001. Epub 2023 Jun 22. No abstract available.
- Wong MKH, Sit AKY, Au TWK. Minimally invasive thoracic surgery: beyond surgical access. J Thorac Dis. 2018 Jun;10(Suppl 16):S1884-S1891. doi: 10.21037/jtd.2018.05.196.
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 (Estimated)
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
- Bursa City Hospital 001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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