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

NCT06571188 | Completed DMC

• 1 other identifier: 8/2024ANET6-1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (2)

• MORPHINE CONSUMPTION

  cumulative 24 h opioid (morphine) consumption

  24 hours

• Numeric rating scale

  is an 11-point scale scored from 0-10: 1. "0" = no pain 2. "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 Outcomes (4)

• Time for first rescue analgesia

  24 hours

• The number of rescue analgesics

  24 hours

• Time to ambulation

  24 hours

• Complications

  24 hours

Study Arms (2)

TEB GROUP

ACTIVE COMPARATOR

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

ESPB group

ACTIVE COMPARATOR

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

Interventions

THORACIC EPIDURAL BLOCK OTHER

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.\].

Also known as: TEB

TEB GROUP

ERECTOER SPINE BLOCK OTHER

The ESP block will be performed as described by Forero et al

Also known as: ESPB

ESPB group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia university

Cairo, Shibin Elkom, 23535, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• AMAL G SAFAN, MD

  Menoufia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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 . 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.Anaesthesiologists who perform the nerve block and take charge of intraoperative management and surgeons are independent individuals.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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anaethesia

Model Details: 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

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 10, 2024
• Last Updated: March 20, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)