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Recruiting NCT07275047

Analgesic Efficacy of SPSIP Block Versus Paravertebral Block Following Thoracotomy

No phase Interventional Post-thoracotomy Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Serratus Posterior Superior Intercostal Plane Block, Thoracic Paravertebral Block.
Who it may be relevant to
Registry conditions: Post-thoracotomy Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of Ultrasound Guided Serratus Posterior Superior Intercostal Plane Block Versus Paravertebral Block for Postoperative Analgesia After Thoracotomy

Overview

Thoracotomy causes severe postoperative pain that may impair respiratory function and increase complications. This study compares the postoperative analgesic effectiveness of the serratus posterior superior intercostal plane (SPSIP) block and the paravertebral block in patients undergoing thoracotomy. The aim is to determine whether the newly described serratus posterior superior intercostal plane block can serve as a safe and effective alternative to established techniques.

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.

Interventions

  • Procedure Serratus Posterior Superior Intercostal Plane Block
    Ultrasound-guided regional anesthesia technique performed between the serratus posterior superior muscle and intercostal muscles.
  • Procedure Thoracic Paravertebral Block
    Ultrasound-guided injection of local anesthetic into the thoracic paravertebral space to provide unilateral analgesia.

Primary outcome measures

  • Postoperative 24-Hour PCA Opioid Consumption [Time frame: Postoperative 24 hours]
Secondary outcome measures (4)
  • NRS Pain Scores at Rest and Movement [Time frame: 2, 4, 8, 16, 24, and 48 hours postoperatively]
  • 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.]]
  • Chronic Pain Assessment [Time frame: 3 months postoperatively]
  • Rescue Analgesic Requirement [Time frame: Postoperative 0-48 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Bursa City Hospital — Bursa

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. PMID 24968967
  • 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. PMID 19307137
  • 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. PMID 37465231
  • 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. PMID 36883093
  • 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. PMID 38664657
  • 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. PMID 31741339

Identifiers

NCT: NCT07275047 · Bursa City Hospital 13

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗