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

Not Applicable

Completed

• Conditions: Post Operative Pain
• Interventions: Other: ERECTOER SPINE BLOCK; Other: THORACIC EPIDURAL BLOCK

• Registration Number: NCT06571188
• Lead Sponsor: Menoufia University

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

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-01
• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Study First Posted: 2024-08-26
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-10
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESPB group	ERECTOER SPINE BLOCK	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
TEB GROUP	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.\].

Primary Outcome Measures

Name	Time	Method
MORPHINE CONSUMPTION	24 hours	cumulative 24 h opioid (morphine) consumption
Numeric rating scale	24 hours	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Menoufia university; 🇪🇬 Cairo, Shibin Elkom, Egypt