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Efficacy of Ipsilateral High Thoracic Ultrasound-guided Erector Spinae Plane Block in Thoracic Cancer Surgeries

Primary Purpose

Thoracotomy, Erector Spinae Plane Block, Thoracic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Thoracic Epidural Analgesia (TEA) group
Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thoracotomy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. American Society of Anesthesiologists (ASA) physical status class I and II.
  2. Age ≥ 18 and ≤ 60 Years.
  3. Patients undergoing thoracic surgery e.g.: metastatectomy, lobectomy, pneumonectomy or pleuro-pneumonectomy.

Exclusion Criteria:

  1. Patient refusal.
  2. Local infection at the puncture site.
  3. Coagulopathy with the international normalized ratio (INR) ≥ 1.6: hereditary (e.g. hemophilia, fibrinogen abnormalities and deficiency of factor II) - acquired (e.g. impaired liver functions with prothrombin concentration less than 60 %, vitamin K deficiency & therapeutic anticoagulants drugs).
  4. Unstable cardiovascular disease.
  5. History of psychiatric and cognitive disorders.
  6. Patients allergic to medication used.

Sites / Locations

  • National Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Thoracic Epidural Analgesia (TEA) group

Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group

Arm Description

Patients in this group will receive Thoracic Epidural analgesia.

Patients in this group will receive Thoracic Epidural analgesia in addition to high thoracic ultrasound-guided erector spinae plane block (ESPB).

Outcomes

Primary Outcome Measures

Percentage of patients with ipsilateral shoulder pain.
Percentage of patients with ipsilateral shoulder pain with a Visual Analogue Scale (VAS) ≥ 3 where (0 = no pain and 10 = severe pain) in the first postoperative hour.

Secondary Outcome Measures

Time to first rescue analgesia
Time to first analgesic request after surgery in the form of intravenous morphine in a dose (0.05 mg/kg)
Changes in postoperative heart rate
Heart rate will be recorded before block performance and before induction of anesthesia, intraoperatively every 10 min till the end of surgery and after surgery at T (30 min in Post-Anesthesia Care Unit (PACU), 2, 4, 6, 12, 24 hours).
Changes in postoperative in mean arterial blood pressure
Mean arterial blood pressure will be recorded before block performance and before induction of anesthesia, intraoperatively every 10 min till the end of surgery and after surgery at T (30 min in Post-Anesthesia Care Unit (PACU), 2, 4, 6, 12, 24 hours).
Total intra-operative fentanyl consumption.
In case of an elevation of heart rate or mean arterial blood pressure ≥ 20% of the baseline will be treated by fentanyl 0.5 μg / kg.
Changes in postoperative oxygen saturation
Mean oxygen saturation at predetermined time intervals (1, 2, 6, 12 and 24 hours).
Complications occurrence
Adverse events as bradycardia, hypotension, failed block, local anesthetic toxicity, drowsiness and dizziness.

Full Information

First Posted
February 3, 2022
Last Updated
February 17, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05238688
Brief Title
Efficacy of Ipsilateral High Thoracic Ultrasound-guided Erector Spinae Plane Block in Thoracic Cancer Surgeries
Official Title
Evaluation of the Efficacy of Ipsilateral High Thoracic Ultrasound-guided Erector Spinae Plane Block in Preventing Post-thoracotomy Shoulder Pain in Thoracic Cancer Surgeries: A Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 12, 2022 (Actual)
Primary Completion Date
March 15, 2023 (Anticipated)
Study Completion Date
March 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the effectiveness of ultrasound guided Erector Spinae Plane Block (ESPB) in controlling post thoracotomy ipsilateral shoulder pain.
Detailed Description
The aim of thoracotomy surgery is to explore the thoracic cavity and manage different pathologies including pulmonary, diaphragmatic, mediastinal, esophageal and vascular pathologies. It can be performed posterolaterally, anterolaterally or even anteriorly. Post-thoracotomy Ipsilateral Shoulder Pain could undermine pain management in the post-thoracotomy patient. Erector spinae plane block is a relatively novel block and was first described for chronic thoracic neuropathic pain in 2016. It is an inter-fascial plane block, but it may be classified as a paraspinal block due to its mechanism of action and injection site. It has been reported for a variety of indications, as in thoracic neuropathic pain and in postoperative analgesia after major open abdominal surgery. Erector spinae plane block has been successfully used to treat chronic shoulder pain, and the local anesthetic spread was reported to reach the level of C3 when it was performed at T2. Ultrasound imaging made the practice of regional anesthesia easier in visualization and identification of usual and unusual position of nerves, blood vessels, needle during its passage through the tissues, as well as deposition and spread of local anesthetics in the desired plane and around the desired nerve.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracotomy, Erector Spinae Plane Block, Thoracic Cancer, Shoulder Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thoracic Epidural Analgesia (TEA) group
Arm Type
Experimental
Arm Description
Patients in this group will receive Thoracic Epidural analgesia.
Arm Title
Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group
Arm Type
Experimental
Arm Description
Patients in this group will receive Thoracic Epidural analgesia in addition to high thoracic ultrasound-guided erector spinae plane block (ESPB).
Intervention Type
Procedure
Intervention Name(s)
Thoracic Epidural Analgesia (TEA) group
Intervention Description
Under full aseptic conditions while the patient is in setting position, skin infiltration will be done with 2 ml of 1% lidocaine an 18-G Tuohy needle with a 20-G catheter (Perifix, B.Braun, Germany) will be inserted through the T6-T7 interspace, and the epidural space located using the loss of resistance technique. The catheter then advanced approximately 3 cm cephalic. A test dose of 3 ml of 1% lidocaine containing epinephrine in a ratio of 1:200,000 administered to detect unintentional intrathecal . After negative response, 15 ml of 0.25% epidural bupivacine will be injected and the patient will be turned to the supine position.
Intervention Type
Procedure
Intervention Name(s)
Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group
Intervention Description
Thoracic Epidural Analgesia will be done at first. Then, the ultrasound probe will be placed longitudinally 2-3 cm lateral to the T2 spinous process in the sagittal line. The T2 spinous process will be identified by counting down anatomically from the vertebral prominens (C7), and the T2 transverse process will be visualized by counting down from the first rib via real-time ultrasound guidance. The erector spinae muscle will be visualized above the T2 transverse process. The needle will be inserted in a caudal cranial direction using the in-plane technique. A dose of 5 mL normal saline will be injected into the inter-fascial area between the erector spinae muscle and the transverse process for the correction of the injection site (hydro-dissection). After hydro-dissection, 15 mL of 0.25% bupivacaine will be injected here, and the linear spread of the solution will be visualized in the inter-fascial plane.
Primary Outcome Measure Information:
Title
Percentage of patients with ipsilateral shoulder pain.
Description
Percentage of patients with ipsilateral shoulder pain with a Visual Analogue Scale (VAS) ≥ 3 where (0 = no pain and 10 = severe pain) in the first postoperative hour.
Time Frame
one hour postoperatively
Secondary Outcome Measure Information:
Title
Time to first rescue analgesia
Description
Time to first analgesic request after surgery in the form of intravenous morphine in a dose (0.05 mg/kg)
Time Frame
24 hours postoperatively
Title
Changes in postoperative heart rate
Description
Heart rate will be recorded before block performance and before induction of anesthesia, intraoperatively every 10 min till the end of surgery and after surgery at T (30 min in Post-Anesthesia Care Unit (PACU), 2, 4, 6, 12, 24 hours).
Time Frame
Preoperatively, intraoperatively, and 24 hours postoperatively
Title
Changes in postoperative in mean arterial blood pressure
Description
Mean arterial blood pressure will be recorded before block performance and before induction of anesthesia, intraoperatively every 10 min till the end of surgery and after surgery at T (30 min in Post-Anesthesia Care Unit (PACU), 2, 4, 6, 12, 24 hours).
Time Frame
Preoperatively, intraoperatively, and 24 hours postoperatively.
Title
Total intra-operative fentanyl consumption.
Description
In case of an elevation of heart rate or mean arterial blood pressure ≥ 20% of the baseline will be treated by fentanyl 0.5 μg / kg.
Time Frame
intraoperatively
Title
Changes in postoperative oxygen saturation
Description
Mean oxygen saturation at predetermined time intervals (1, 2, 6, 12 and 24 hours).
Time Frame
24 hours postoperatively
Title
Complications occurrence
Description
Adverse events as bradycardia, hypotension, failed block, local anesthetic toxicity, drowsiness and dizziness.
Time Frame
24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status class I and II. Age ≥ 18 and ≤ 60 Years. Patients undergoing thoracic surgery e.g.: metastatectomy, lobectomy, pneumonectomy or pleuro-pneumonectomy. Exclusion Criteria: Patient refusal. Local infection at the puncture site. Coagulopathy with the international normalized ratio (INR) ≥ 1.6: hereditary (e.g. hemophilia, fibrinogen abnormalities and deficiency of factor II) - acquired (e.g. impaired liver functions with prothrombin concentration less than 60 %, vitamin K deficiency & therapeutic anticoagulants drugs). Unstable cardiovascular disease. History of psychiatric and cognitive disorders. Patients allergic to medication used.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Megahed, MSc
Phone
1002035763
Ext
+20
Email
Mu.megahed@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Megahed, MSc
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad M Megahed
Phone
00201002035763
Email
mamdouh.mahmoud@nci.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
This study will be available upon a reasonable request from the corresponding author.
IPD Sharing Time Frame
One year after the end of the study.

Learn more about this trial

Efficacy of Ipsilateral High Thoracic Ultrasound-guided Erector Spinae Plane Block in Thoracic Cancer Surgeries

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