Analgesic Efficacy of SPSIP Block Versus Paravertebral Block Following Thoracotomy

NCT07275047 | Recruiting

• 1 other identifier: Bursa City Hospital 13
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-thoracotomy Pain

Keywords

Post-thoracotomy pain; Serratus posterior superior intercostal plane block; Paravertebral Block; Pain management

Outcome Measures

Primary Outcomes (1)

• Postoperative 24-Hour PCA Opioid Consumption

  Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 24 hours after surgery, recorded in milligrams (mg).

  Postoperative 24 hours

Secondary Outcomes (4)

• NRS Pain Scores at Rest and Movement

  2, 4, 8, 16, 24, and 48 hours postoperatively

• QoR-15 Recovery Score

  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

  3 months postoperatively

• Rescue Analgesic Requirement

  Postoperative 0-48 hours

Study Arms (2)

Group SPSIP

ACTIVE COMPARATOR

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.

Procedure: Serratus Posterior Superior Intercostal Plane Block

Group Paravertebral

ACTIVE COMPARATOR

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.

Procedure: Thoracic Paravertebral Block

Interventions

Serratus Posterior Superior Intercostal Plane Block PROCEDURE

Ultrasound-guided regional anesthesia technique performed between the serratus posterior superior muscle and intercostal muscles.

Also known as: SPSIP Block

Group SPSIP

Thoracic Paravertebral Block PROCEDURE

Ultrasound-guided injection of local anesthetic into the thoracic paravertebral space to provide unilateral analgesia.

Also known as: Paravertebral Block

Group Paravertebral

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa City Hospital: lead

Study Sites (1)

Bursa City Hospital

Bursa, 16110, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mursel Ekinci, Assoc prof,MD

CONTACT

+905067137596; drmurselekinci@gmail.com

Mustafa Dikici, MD

CONTACT

+905055346540; mus.dikici88@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)