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Clinical Trials/NCT05409144
NCT05409144
Unknown
Not Applicable

Impact of Thoracic Epidural Infusion Versus Continuous Serratus Anterior Plane Block Versus Continuous Erector Spinae Plane Block on Incidence of Post Thoracotomy Pain Syndrome: A Randomized Controlled Trial

National Cancer Institute, Egypt0 sites111 target enrollmentJune 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-thoracotomy Pain Syndrome
Sponsor
National Cancer Institute, Egypt
Enrollment
111
Primary Endpoint
Incidence of patients developing post-thoracotomy pain syndrome
Last Updated
3 years ago

Overview

Brief Summary

The aim of this study is to evaluate the impact of Ultrasound-guided Erector Spinae plane block compared to Ultrasound-guided serratus anterior plane block on the emergence of post-thoracotomy pain syndrome in patients undergoing lobectomy for lung cancer.

Detailed Description

Lung cancer has the highest incidence of all malignancies worldwide and accounts for approximately 13% of all cancer cases. Lung cancer is still the most common cause of cancer-related deaths, and lung resection surgeries could be the main therapeutic option. Hence, the number of thoracotomy procedures is progressively increasing as is the incidence of post-thoracotomy pain. In addition to amputation and mastectomy, thoracotomy is considered the main etiology of severe and long-term acute and chronic post-surgical pain syndromes (CPSPs). The prevalence of post-thoracotomy pain syndrome (PTPS) is widely variable (30%-50%) and may range from 11% to 80%, according to other studies. The International Association for the Study of Pain (IASP) has defined post-thoracotomy pain syndrome as "pain that recurs or persists along the thoracotomy scar at least 2 months after the procedure". In addition, post-thoracotomy pain syndrome is mostly described with neuropathic manifestations along the thoracotomy scar and in the mammary, inframammary, ipsilateral scapular and interscapular areas. The ultrasound-guided erector spinae plane (ESP) block is a novel technique for thoracic analgesia that promises to be a relatively simple and safe alternative to more complex and invasive techniques of neural blockade.

Registry
clinicaltrials.gov
Start Date
June 20, 2022
End Date
April 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Cancer Institute, Egypt
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Shaban Mohammed

assisstant lecturer

National Cancer Institute, Egypt

Eligibility Criteria

Inclusion Criteria

  • Age (18-65) Years
  • Physical status American Society of Anesthesiologists Classification II, III
  • Patients undergoing lobectomy through lateral thoracotomy
  • Body mass index (BMI): (20-40) kg/m2

Exclusion Criteria

  • Patient refusal.
  • Age \<18 years or \>65 years
  • Body mass index (BMI) \<20 kg/m2 and \>40 kg/m2
  • Known sensitivity or contraindication to drugs used in the study
  • Contraindication to regional anesthesia e.g. local infection at site of introduction, pre-existing peripheral neuropathies and coagulopathy.
  • Pregnancy.
  • Physical status American Society of Anesthesiologists Classification IV
  • patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
  • patients with a history of drug abuse
  • patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia

Outcomes

Primary Outcomes

Incidence of patients developing post-thoracotomy pain syndrome

Time Frame: 12 weeks postoperatively

The incidence of patients developing post-thoracotomy pain syndrome according to grading system for neuropathic pain (GSNP

Secondary Outcomes

  • Morphine consumption(48 hours Postoperatively)
  • Fentanyl consumption(Intraoperatively)
  • Post-thoracotomy pain syndrome severity(12 weeks postoperatively)
  • Patient's Quality of life(12 weeks postoperatively)
  • Postoperative Patient's activity level(12 weeks postoperatively)
  • Heart rate(Intraoperatively)
  • Mean arterial blood pressure(Intraoperatively)
  • Nausea and vomiting(24 hours postopertivley)
  • Post-operative pain(24 hours postopratively)
  • Time taken till 1st rescue analgesic request(24 hours postopratively)
  • Postoperative pulmonary complications(24 hours postopratively)

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