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

NCT05238688 | Completed

• 1 other identifier: AP2109-30108
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effectiveness of ultrasound guided Erector Spinae Plane Block (ESPB) in controlling post thoracotomy ipsilateral shoulder pain.

Conditions

Thoracotomy; Erector Spinae Plane Block; Thoracic Cancer; Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  one hour postoperatively

Secondary Outcomes (6)

• Time to first rescue analgesia

  24 hours postoperatively

• Changes in postoperative heart rate

  Preoperatively, intraoperatively, and 24 hours postoperatively

• Changes in postoperative in mean arterial blood pressure

  Preoperatively, intraoperatively, and 24 hours postoperatively.

• Total intra-operative fentanyl consumption.

  intraoperatively

• Changes in postoperative oxygen saturation

  24 hours postoperatively

Study Arms (2)

Thoracic Epidural Analgesia (TEA) group

EXPERIMENTAL

Patients in this group will receive Thoracic Epidural analgesia.

Procedure: Thoracic Epidural Analgesia (TEA) group

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

EXPERIMENTAL

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

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

Interventions

Thoracic Epidural Analgesia (TEA) group PROCEDURE

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.

Thoracic Epidural Analgesia (TEA) group

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

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.

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Tea; Population Groups

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Demography; Population Characteristics

Study Officials

• Muhammad Megahed, MSc

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: August 12, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the study.

Locations

EG (1)