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NCT Number: NCT07275047

Analgesic Efficacy of SPSIP Block Versus Paravertebral Block Following Thoracotomy

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.

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Key information

Conditions

Post-thoracotomy Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serratus Posterior Superior Intercostal Plane Block

Procedure

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

Other names: SPSIP Block

Thoracic Paravertebral Block

Procedure

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

Other names: Paravertebral Block

Primary outcomes

  1. Postoperative 24-Hour PCA Opioid Consumption

    Time frame: Postoperative 24 hours

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

Secondary outcomes

  1. NRS Pain Scores at Rest and Movement

    Time frame: 2, 4, 8, 16, 24, and 48 hours postoperatively

    Numeric Rating Scale (NRS) (0-10) pain scores at rest and during movement or coughing at predefined postoperative hours.

  2. 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.]

    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

  3. Chronic Pain Assessment

    Time frame: 3 months postoperatively

    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.

    • Pain Severity Subscale (4 Items): Assesses pain intensity over the last 24 hours. (0-10) What is your pain level right now What was your pain at its least in the last 24 hours What was your pain at its worst in the last 24 hours What was your pain on average in the last 24 hours
    • Pain Interference Subscale (7 Items): Assesses the degree to which pain interferes with daily functioning Questions: The patient rates how much pain interfered with: (0-10) General activity Mood Walking ability Normal work Relations with people Sleep Enjoyment of life

  4. Rescue Analgesic Requirement

    Time frame: Postoperative 0-48 hours

    Number of patients requiring rescue analgesia (IV meperidine 0.5 mg/kg) and total dose administered when NRS ≥ 4.

Study contacts

Contact information is provided by the study sponsor or research team.

Mursel Ekinci, Assoc prof,MD

CONTACT

[email protected]

+905067137596

Mustafa Dikici, MD

CONTACT

[email protected]

+905055346540

Sponsors and collaborators

Lead sponsor

Bursa City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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