Continuous Ultrasound Guided Erector Spinae Plane Block vs Thoracic Paravertebral Block

Continuous Ultrasound Guided Erector Spinae Plane Block vs Thoracic Paravertebral Block for Postoperative Analgesia in Patients Undergoing Thoractomy

in this study the investigators will investigate and compare the analgesic efficacy of two techniques (continuous TPVB and continuous ESPB) in relieving thoracotomy pain

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Other: continuous Thoracic paravertebral block; Other: continuous Erector spinae plane block

Detailed Description

General Anesthesia will be induced with Fentanyl (1-2 μg/kg), Propofol (2-3 mg/kg), and Atracurium (0.5-0.8 mg/kg). Pressure controlled Volume guarantee Ventilation mode will be used to maintain O2 Saturation Above 98% and End tidal co2 Around 30-35 mmHg. Anesthesia will be maintained with Isoflurane 1.2 Minimum Alveolar Concentration inhalation after induction Group A: Patients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous infusion U/S-Guided TPVB of 5 ml/h of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative and Group B: Patients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous U/S-Guided ESPB of 5 ml/h of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Shibin Elkom
    • Cairo, Shibin Elkom, Egypt
      • Menoufia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- Eligible 40 patients will be older than 21 years old with American society of anesthesia physical status I& II scheduled for elective thoracotomy

Exclusion Criteria:

• Patients who are:
• Uncooperative.
• Having allergy to any of the study drugs.
• Known abuse of alcohol or medication.
• Having Local infection at the site of injection or systemic infection.
• Pregnancy.
• With coagulation disorders or on anticoagulation therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Patients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous infusion U/S-Guided TPVB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative	Other: continuous Thoracic paravertebral block; continuous infusion U/S-Guided TPVB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative.; Other Names: TPVB
Active Comparator: Group B; Patients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous U/S-Guided ESPB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative.	Other: continuous Erector spinae plane block; continuous U/S-Guided ESPB of 5 ml/hr of 0.125% bupivacaine started through the catheter before the surgical procedure; Other Names: ESPB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the VAS score postoperative of (U/S)-guided continuous (ESPB) to continuous (TPVB) following thoracotomy	visual analogue scale (VAS) Score	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 st call analgesia	mg	1 hour
Total rescue opioid dose used	mg	48 hour
patient satisfaction at 24 hours		24 hours
occurrence of adverse events		24hours
hospital stay	days	1 week

Collaborators and Investigators

• Sponsor: Amal Gouda Elsayed Safan
• Collaborators: Mohamed Emad Basune; Wesam Eldin Sultan; Rabab Mohammed Habeeb
• Investigators: Study Director: Wesam Eldin Sultan, MD, Menoufia University; Principal Investigator: Mohamed Emad Basune, Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Actual): October 10, 2023
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2/2023ANET10-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No