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Recruiting NCT06618599

Mid-transverse Process Combined With Erector Spinae Block Versus Paravertebral Plane Block

No phase Interventional Lung Cancer

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: Mid-transverse process to pleura block combined with erector spinae block, paravertebral block.
Who it may be relevant to
Registry conditions: Lung Cancer. 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
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Analgesic Effect of Mid-transverse Process to Pleura Block Combined With Erector Spinae Block Versus Paravertebral Plane Block in Thoracic Surgery for Lung Cancer Patients

Overview

This study aims to compare efficacy of Mid-transverse process to pleura block combined with erector spinae block versus paravertebral plane block in cancer patients undergoing thoracotomy surgeries.

Detailed description

Thoracic paravertebral block (TPVB) application has also been used in recent years due to the lower incidence of side effects. The erector spinae plane block (ESPB)has been used as a part of multimodal analgesia in recent years. In ESPB is aimed to treat the postoperative pain of the thoracoabdominal region by injecting a local anesthetic into the interfacial area under the erector spinae muscle . ESPB creates an effect that covers the posterior and lateral thorax by affecting the dorsal rami and branches of the spinal nerves . Midtransverse process to pleura (MTP) block is less invasive as the position of the needle in this block is midway between the transverse process' posterior border and the pleura. Due to fenestrations present in the superior costotransverse ligament (SCTL), the drug reaches the paravertebral space

Interventions

  • Procedure Mid-transverse process to pleura block combined with erector spinae block
    The probe will be placed vertically 3 cm lateral to the T5 spinous process and the transverse process will be identified. The needle will be introduced in an in-plane fashion until the tip lay deep in the erector spinae muscle. One milliliter of normal saline will be injected to confirm the correct needle tip position by visualizing the spread under the erector spinae muscle. 20 mL of 0.25% bupivacaine will be injected .The needle will be directed aiming for the midpoint between the transverse p
  • Procedure paravertebral block
    the transducer will be positioned laterally 3 cm to the midline at T5 spinous process, defining the spinous process, pleura, transverse process, the paravertebral (PV) space, and superior costotransverse ligament. The trapezius, rhomboid major, and erector spinae muscles will be recognized as superficial to the hyperechoic transverse process shadow. However, when the rhomboid major muscle disappeared, this indicated that we will be at the 7th thoracic vertebra's level. Local infiltration using 2

Primary outcome measures

  • visual analogue score changes during rest and cough for the three groups. [Time frame: for 24 hours postoperative]

Eligibility criteria

Inclusion criteria

  • lung cancer patients for thoracotomy surgeries.
  • Physical status American Society of Anesthesiologists (ASA )II, III.
  • Age ≥ 18 and ≤ 65 Years.
  • Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2

Exclusion criteria

  • Patient refusal
  • physical status ASA IV,
  • Age \<18 years or \>65 years
  • BMI \< 20 kg/m2 and \>35 kg/m2
  • Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
  • History of psychological disorders and/or chronic pain.
  • Contraindication to regional anesthesia e.g., local sepsis, pre- existing peripheral neuropathies, and coagulopathy.
  • Severe respiratory, cardiac, hepatic or renal disease.

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

Egypt · 1 center
  • Cairo University — Cairo

Publications

  • Zengin M, Alagoz A. Comparison of Thoracic Epidural Analgesia and Thoracic Paravertebral Block Applications in the Treatment of Acute Pain After Thoracotomy in Geriatric Patients. Cureus. 2021 Oct 22;13(10):e18982. doi: 10.7759/cureus.18982. eCollection 2021 Oct. PMID 34820237
  • Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366. PMID 26509324
  • Liu L, Ni XX, Zhang LW, Zhao K, Xie H, Zhu J. Effects of ultrasound-guided erector spinae plane block on postoperative analgesia and plasma cytokine levels after uniportal VATS: a prospective randomized controlled trial. J Anesth. 2021 Feb;35(1):3-9. doi: 10.1007/s00540-020-02848-x. Epub 2020 Sep 4. PMID 32886200

Identifiers

NCT: NCT06618599 · analgesia in thoracotomy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗