Comparison of Ultrasound-Guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia (TEAVSESPB)

Comparison of Ultrasound-Guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Postoperative Analgesia Following Thoracotomy Surgeries: a Randomised Trial

There are limited studies comparing these two modalities ( thoracic epidural and erector spine block) for relieving the pain after thoracic surgeries .this study aim to investigate this purpose

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Other: THORACIC EPIDURAL BLOCK; Other: ERECTOER SPINE BLOCK

Detailed Description

The random sequence will be sealed in consecutively numbered opaque envelopes and kept by the study coordinator. Participants will be randomly divided into two groups according to the 1:1 ratio of ESPB group and TEB group. A research coordinator is designated to distribute and preserve randomization result. The coordinator will open the envelopes for allocation according to the order of enrolment and prepare the study drug.

The participants will be blinded to the allocation. Because the needle injection of ESPB and TEB are very close, participants themselves could hardly detect the clinical differences. Anaesthesiologists who perform the nerve block and take charge of intraoperative management and surgeons are independent individuals. Only the random sequence number rather than the specific nerve block type will be recorded in the electronic anaesthesia information management system .Researchers who do not take part in the nerve block and intraoperative management are designated to postoperative follow-up. Besides, trained anaesthesiologist who do not perform the block will be designated to evaluate the clinical features of the block objectively

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Shibin Elkom
    • Cairo, Shibin Elkom, Egypt, 23535
      • Menoufia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eligible patients will be from18-70 years old with ( American association of anaesthesiologist) ASA physical status I to III scheduled for elective thoracic surgeries.

Exclusion Criteria:

• Patients who are:
• Unable to cooperate.
• Patients who have allergy to any of the study drugs.
• Patients who are on opioids.
• Local infection at the site of injection or systemic infection.
• Patients with coagulation disorders or on anticoagulation therapy Unable to communicate preoperatively due to severe dementia, language barrier, or neuropsychiatric disorder
• Unable to perform nerve block procedure due to difficult anatomy through ultrasound scan.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TEB GROUP; In group TEB, The epidural catheter will be inserted preoperatively at the T5-T7 vertebral level; the exact level will be at the discretion of the attending anaesthesiologist. A loading dose of bupivacaine 0.25% (max 10 ml) will be administered, followed by an intraoperative infusion of bupivacaine 0.125 % with Fentanyl 1 μg/ml.].	Other: THORACIC EPIDURAL BLOCK; In group TEB, The epidural catheter will be inserted preoperatively at the T5-T7 vertebral level; the exact level will be at the discretion of the attending anaesthesiologist. A loading dose of bupivacaine 0.25% (max 10 ml) will be administered, followed by an intraoperative infusion of bupivacaine 0.125 % with fentanyl 1 μg/ml.].; Other Names: TEB
Active Comparator: ESPB group; In group ESPB, The ESP block will be performed as described by Forero et al. A Tuohy needle will be inserted with an in-plane technique in a caudal to cephalad direction until bony contact with the transverse process is obtained. Hydro dissection with normal saline will be performed to identify and open up the correct plane for injection. A loading dose of Bupivacaine will be injected followed by the insertion of an 18-g catheter 5 cm beyond the needle tip. No further local anaesthetic will be administered intra-operatively. Following the end of surgery, a continuous infusion of 5 ml/h of Bupivacaine 0.125%, supplemented by a 10-ml bolus injection every 3 h, will be administered through the ESPB catheter	Other: ERECTOER SPINE BLOCK; The ESP block will be performed as described by Forero et al; Other Names: ESPB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MORPHINE CONSUMPTION	cumulative 24 h opioid (morphine) consumption	24 hours
Numeric rating scale	is an 11-point scale scored from 0-10: "0" = no pain; "10" = the most intense pain imaginable Patients verbally select a value that is most in line with the intensity of pain that they have experienced in the last 24 hours.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for first rescue analgesia	Time for first rescue analgesia will be measured and recorded	24 hours
The number of rescue analgesics	the number of rescue analgesics within 24hrs after surgery will be recorded	24 hours
Time to ambulation	Time to ambulation WILL BE RECOREDED	24 hours
Complications	Complications like bradycardia or hypotension, itching, nausea and vomiting will be recorded.	24 hours

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Principal Investigator: AMAL G SAFAN, MD, Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: 8/2024ANET6-1

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
• product manufactured in and exported from the U.S.: No