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Not yet recruiting NCT07437027

Analgesic Efficiency of Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Patients Undergoing Lateral Thoracotomy Using Opoid Sparing Anesthesia

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: Group A :Thoracic paravertebral block, Erector Spinae Plane Block.
Who it may be relevant to
Registry conditions: Post Thoracotomy Pain. Basic parameters: 18 years — 70 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 Efficiency of Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Patients Undergoing Lateral Thoracotomy Using Opoid Sparing Anesthesia . A Comparative Study

Overview

AimoftheWork To assess the efficiency of Opoid free anaesthesia with paravertebral block compared to opoid free anaesthesia with erector spinae plane block in patients undergoing Thoracotomy.

Detailed description

There is growing evidence showing that opoid-free anesthesia (OFA), including loco-regional anesthesia and non-opioid drugs, is feasible in several surgical settings. The surgeries for pathologies involving the lungs and mediastinum involves different types of thoracic surgical incision such as anterolateral or posterolateral.

Post thoracotomy pain affects 30%-50% of the patients undergoing thoracotomy.Poorly managed pain following thoracotomy can lead to increase the risk of complications such as lung collapse and chest infections due to altered mechanical functions of the lungs and ventilation-perfusion mismatch. Acute thoracotomy pain is multifactorial in nature. It involves nociceptive and neuropathic mechanisms originating from somatic and visceral afferents. The main sources of pain are intercostal nerves,the vagus nerve and phrenic nerve in the pleura, the superficial cervical plexus, and the brachial plexus in the ipsilateral shoulder.

So, Analgesia is a major determinant of balanced anesthesia and it is usually achieved by administering opioid agents, which are well tolerated and maintain hemodynamic stability in the perioperative period. However, perioperative opioid administration is not risk-free. Opioids are associated with life-threatening side effects such as respiratory depression, postoperative nausea and vomiting, opioid-induced hyperalgesia, constipation, urinary retention, immunomodulation and neurotoxicity. In addition, opioid prescription after surgery seems to trigger the development of opioid addiction, thus contributing to the widespread opioid misuse observed worldwide. Several studies found a correlation between postoperative opioid administration, the development of chronic pain and opioid addiction.

Therefore,opioid administration should be reduced or avoided as much as possible.

Thoracic epidural analgesia (TEA) is considered as the gold standard for thoracotomy pain(4)However, according to a recent systematic review, The thoracic paravertebral block (TPVB) has been shown to be as effective as TEA with reduction of the risks of minor complications compared to TEA.

Emerging research has shown that the novel erector spinaeplane block(ESPB) can be employed as a simple and safe alternative analgesic technique for acute postsurgical, post-traumatic, and chronic neuropathic thoracic pain in adults.

The goal of this study is to assess the Analgesic efficiency of erector spinae plane block versus thoracic paravertebral block in patients undergoing lateral thoracotomy using opoid sparing anesthesia.

Interventions

  • Procedure Group A :Thoracic paravertebral block
    Ultrasound guided thoracic paravertebral block performed at the T5 level using 20 ml of 0.5% bupivacaine for postoperative analgesia in patients undergoing lateral thoracotomy
  • Procedure Erector Spinae Plane Block
    ultrasound guided erector spinae plane block will be performed at the T5 level using 20 ml of 0.5% bupivacaine as part of an opoid sparing anesthesia protocol for lateral thoracotomy

Primary outcome measures

  • Total morphine consumption for the first 24 hours postoperative [Time frame: Within the first 24 hours postoperative]
Secondary outcome measures (1)
  • Postoperative pain [Time frame: At 0,2,6,12,24 hours post operative]

Eligibility criteria

Inclusion criteria

  • Patients age between 18 and 70 .
  • Patients with ASAII and IIIstatus.
  • Patients undergoing open surgical Thoracotomy as in lobectomy, pneumonectomy, segmentectomy and decortication.
  • Gender both males and females.

2.Exclusioncriteria

  • Refusal of the patient.
  • Allergy to local anesthetic
  • Infection of the skin at the site of local infiltration
  • Cardiovascular problems (arrhythmia, heart block, SVT,AF, multiple extra systole).
  • Any contraindication to regional anesthesia as coagulopathy
  • Patients with chronic pain or on opoid medication preoperative

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
Quadruple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Kasr al aini hospital — Cairo

Publications

  • Doan LV, Augustus J, Androphy R, Schechter D, Gharibo C. Mitigating the impact of acute and chronic post-thoracotomy pain. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):1048-56. doi: 10.1053/j.jvca.2014.02.021. No abstract available. PMID 25107721
  • Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20. PMID 18443635
  • Marshall K, McLaughlin K. Pain Management in Thoracic Surgery. Thorac Surg Clin. 2020 Aug;30(3):339-346. doi: 10.1016/j.thorsurg.2020.03.001. Epub 2020 Apr 29. PMID 32593366
  • Mamoun N, Wright MC, Bottiger B, Plichta R, Klinger R, Manning M, Raghunathan K, Gulur P. Pain Trajectories After Valve Surgeries Performed via Midline Sternotomy Versus Mini-Thoracotomy. J Cardiothorac Vasc Anesth. 2022 Sep;36(9):3596-3602. doi: 10.1053/j.jvca.2022.05.007. Epub 2022 May 10. PMID 35641410

Identifiers

NCT: NCT07437027 · Post thoracotomy pain

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗