Analgesic Efficacy of SPSIP Block Versus Paravertebral Block Following Thoracotomy

NCT ID: NCT07275047

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-12-15

Brief Summary

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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

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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.

Conditions

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Post-thoracotomy Pain

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Serratus Posterior Superior Intercostal Plane Block

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Thoracic Paravertebral Block

Intervention Type PROCEDURE

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

Interventions

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Serratus Posterior Superior Intercostal Plane Block

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

Intervention Type PROCEDURE

Thoracic Paravertebral Block

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

Intervention Type PROCEDURE

Other Intervention Names

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SPSIP Block Paravertebral Block

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bursa City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mursel Ekinci

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bursa City Hospital

Bursa, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Mursel Ekinci, Assoc prof,MD

Role: CONTACT

Phone: +905067137596

Email: [email protected]

Mustafa Dikici, MD

Role: CONTACT

Phone: +905055346540

Email: [email protected]

Facility Contacts

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Mustafa Dikici, MD

Role: primary

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 24968967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19307137 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37465231 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36883093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38664657 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31741339 (View on PubMed)

Other Identifiers

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Bursa City Hospital 13

Identifier Type: -

Identifier Source: org_study_id