- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07275047
Analgesic Efficacy of SPSIP Block Versus Paravertebral Block Following Thoracotomy
Comparison of Ultrasound Guided Serratus Posterior Superior Intercostal Plane Block Versus Paravertebral Block for Postoperative Analgesia After Thoracotomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Thoracotomy often causes strong postoperative pain because the ribs, muscles, nerves, and pleura are affected during surgery. This pain can make it difficult for patients to breathe well and may increase the chance of lung problems. Paravertebral block is a well-known method for reducing pain after thoracic surgery, but it can sometimes lead to side effects such as low blood pressure or complications related to deeper needle placement.
The serratus posterior superior intercostal plane block is a newer ultrasound-guided technique. In this method, local anesthetic is injected between the serratus posterior superior muscle and the intercostal muscles. Early studies suggest that it may provide wide pain relief, but its effectiveness specifically in thoracotomy patients has not yet been studied.
This randomized study aims to compare the pain-relieving effects of the serratus posterior superior intercostal plane block with those of the paravertebral block after thoracotomy. The goal is to find out whether this new block can be a safe and effective option for postoperative pain management.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mustafa Dikici, MD
- Phone Number: +905055346540
- Email: mus.dikici88@gmail.com
Study Contact Backup
- Name: Mursel Ekinci, Assoc prof,MD
- Phone Number: +905067137596
- Email: drmurselekinci@gmail.com
Study Locations
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Bursa, Turkey (Türkiye), 16110
- Recruiting
- Bursa City Hospital
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Contact:
- Mustafa Dikici, MD
- Phone Number: +905055346540
- Email: mus.dikici88@gmail.com
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Contact:
- Phone Number: +90224975 00 00
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Scheduled to undergo thoracotomy
- ASA physical status I-III according to the American Society of Anesthesiologists classification
- Able to understand the study procedures and provide written informed consent
Exclusion Criteria:
- Declines or is unable to provide informed consent
- Allergy or hypersensitivity to local anesthetics or opioids
- Known or suspected coagulopathy
- Infection at the injection site
- History of thoracic surgery
- Severe cardiovascular disease
- Hepatic or renal failure
- Pregnant, suspected pregnancy, or breastfeeding
Significant neurological or psychiatric disorder that may interfere with study participatio
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 |
|---|---|
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Active Comparator: Group SPSIP
Participants in this arm will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane Block.
The block will be performed preoperatively with the patient in the appropriate position.
A local anesthetic solution will be injected between the serratus posterior superior muscle and the intercostal muscles under real-time ultrasound guidance.
The technique aims to achieve postoperative analgesia by providing sensory blockade across targeted thoracic dermatomes.
No additional regional block will be performed in this group.
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Ultrasound-guided regional anesthesia technique performed between the serratus posterior superior muscle and intercostal muscles.
Other Names:
|
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Active Comparator: Group Paravertebral
Participants in this arm will receive an ultrasound-guided thoracic paravertebral block.
The block will be performed preoperatively with the patient in the appropriate position.
Under real-time ultrasound guidance, a local anesthetic solution will be injected into the thoracic paravertebral space at the planned level to achieve unilateral somatic and sympathetic nerve blockade.
This intervention is intended to provide postoperative analgesia following thoracotomy.
No additional regional block will be administered in this group.
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Ultrasound-guided injection of local anesthetic into the thoracic paravertebral space to provide unilateral analgesia.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative 24-Hour PCA Opioid Consumption
Time Frame: Postoperative 24 hours
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Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 24 hours after surgery, recorded in milligrams (mg).
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Postoperative 24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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QoR-15 Recovery Score
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.]
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The investigators will use the Turkish version of Quality of Recovery (QoR) / QoR-15 questionairre PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent]) Able to breathe easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate with Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being PART B Have you had 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]) Moderate pain Severe pain Nausea or vomiting Feeling worried or anxious 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.]
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Rescue Analgesic Requirement
Time Frame: Postoperative 0-48 hours
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Number of patients requiring rescue analgesia (IV meperidine 0.5 mg/kg) and total dose administered when NRS ≥ 4.
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Postoperative 0-48 hours
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NRS Pain Scores at Rest and Movement
Time Frame: 2, 4, 8, 16, 24, and 48 hours postoperatively
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Numeric Rating Scale (NRS) (0-10) pain scores at rest and during movement or coughing at predefined postoperative hours.
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2, 4, 8, 16, 24, and 48 hours postoperatively
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Chronic Pain Assessment
Time Frame: 3 months postoperatively
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Pain status using the Brief Pain Inventory (BPI) via telephone follow-up. General Scoring: The BPI comprises the Pain Severity and Pain Interference subscales. Each item is scored on a 0 (None/No interference) to 10 (Worst imaginable/Completely disabling) numerical scale. Higher scores indicate a worse clinical outcome. Subscale scores are calculated by taking the arithmetic mean of relevant items.
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3 months postoperatively
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bayman EO, Brennan TJ. Incidence and severity of chronic pain at 3 and 6 months after thoracotomy: meta-analysis. J Pain. 2014 Sep;15(9):887-97. doi: 10.1016/j.jpain.2014.06.005. Epub 2014 Jun 23.
- Wildgaard K, Ravn J, Kehlet H. Chronic post-thoracotomy pain: a critical review of pathogenic mechanisms and strategies for prevention. Eur J Cardiothorac Surg. 2009 Jul;36(1):170-80. doi: 10.1016/j.ejcts.2009.02.005.
- Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
- Yildirim Y, Parlar Kilic S, Eyigor S, Eyigor C, Yildirim Y, Karaman E, Oyur Celik G, Uyar M. Validity and reliability of Turkish version of the Brief Pain Inventory-Short Form for patients with chronic nonmalignant pain. Agri. 2019 Nov;31(4):195-201. doi: 10.14744/agri.2019.25901.
- 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.
- Akin AN, Yildiz Y, Alver S, Ciftci B. Continuous serratus posterior superior intercostal plane block for postoperative analgesia management in the patient who underwent right atrial mass excision: a case report. BMC Anesthesiol. 2024 Apr 25;24(1):159. doi: 10.1186/s12871-024-02535-4.
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 13
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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