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

NCT ID: NCT06571188

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2024-12-10

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

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

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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.\].

Group Type: ACTIVE_COMPARATOR

THORACIC EPIDURAL BLOCK

Intervention Type: 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.\].

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

Group Type: ACTIVE_COMPARATOR

ERECTOER SPINE BLOCK

Intervention Type: OTHER

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

Interventions

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.\].

Intervention Type: OTHER

ERECTOER SPINE BLOCK

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

Intervention Type: OTHER

Other Intervention Names

TEB; ESPB

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Amal Gouda Elsayed Safan

lecturer of anaethesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AMAL G SAFAN, MD

Role: PRINCIPAL_INVESTIGATOR

Menoufia University

Locations

Menoufia university

Cairo, Shibin Elkom, Egypt

Countries

Egypt

Other Identifiers

8/2024ANET6-1

Identifier Type: -

Identifier Source: org_study_id