Comparison Between Ultrasound-Guided Erector Spinae Plane Block Versus Ultrasound-Guided Caudal Injection

NCT06336161 | Not Yet Recruiting DMC

• 1 other identifier: ESPB versus CEI
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Patient-controlled analgesia is typically used to relieve postoperative pain. Patient-controlled analgesia, on the other hand, is prone to opioid-related side effects. Furthermore, standard postoperative analgesia has a limited analgesic impact. If postoperative lumbosacral spine pain is not successfully treated, it can progress to chronic pain, compromising patients' quality of life. The methods of access for epidural injections are characterized as transforaminal, interlaminar, or caudal. Caudal epidural injections (CEI) are often utilized as a diagnostic or therapeutic tool in a range of lumbosacral-originating spinal pain problems, and they are especially useful in patients with complicated lumbar epidural access diseases, such as post laminectomy syndrome. It is regarded as a very simple treatment in the realm of interventional pain management, and it is also recognized to have a reduced risk of inadvertent Dural puncture than other epidural techniques

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Measurement of Post-operative Pain

  Assessment of Pain after operations will be evaluated using the VAS consisting of a horizontal or vertical line, 10 centimeters long (100 mm) anchored at the extremes by two verbal descriptors referring to the pain status

  the first 24 hours postoperatively

Study Arms (2)

Group A ( Erector Spinae Plane Block)

ACTIVE COMPARATOR

About 40 patients who will be subjected to Ultrasound-Guided Erector Spinae Plane Block.for Postoperative Pain Management

Drug: Fentanyl

Group B (Caudal Injection)

ACTIVE COMPARATOR

About 40 patients who will be subjected to Ultrasound-Guided Caudal Injection in Lumbosacral Spine Surgeries for Postoperative Pain Management

Drug: Fentanyl

Interventions

Fentanyl DRUG

to compare between Ultrasound-Guided ESPB and Ultrasound-Guided CEI for postoperative pain relief in patients who underwent lumbosacral surgeries.

Also known as: propofol 2Mg/Kg

Group A ( Erector Spinae Plane Block); Group B (Caudal Injection)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing lumbosacral spine surgeries from (L4-L5) level to end of spinal cord.
• American society of anesthesiologists' classification (ASA) I \& II.

You may not qualify if:

• Patient's refusal.
• History of any previous back surgeries.
• History of any spinal cord deformities e.g., Scoliosis, Lordosis, Kyphosis, Ankylosing Spondylitis
• Bleeding disorders (platelets count \< 80,000; International normalized ratio \>1.4; PC\< 70%) and coagulopathies.
• Skin lesion, wounds, or infection at the injection site.
• Known allergy to local anesthetic drugs.
• Peripheral and Central Neuropathy.
• Patients with pre-operative opioid consumption.
• Chronic opioids or analgesics users.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University hospitals

Cairo, Egypt

Location

Related Publications (2)

• Patel Y, Ramachandran K, Shetty AP, Chelliah S, Subramanian B, Kanna RM, Shanmuganathan R. Comparison Between Relative Efficacy of Erector Spinae Plane Block and Caudal Epidural Block for Postoperative Analgesia in Lumbar Fusion Surgery- A Prospective Randomized Controlled Study. Global Spine J. 2025 Mar;15(2):639-647. doi: 10.1177/21925682231203653. Epub 2023 Sep 22.

  PMID: 37737097 RESULT

• Shah M, Halalmeh DR, Sandio A, Tubbs RS, Moisi MD. Anatomical Variations That Can Lead to Spine Surgery at the Wrong Level: Part III Lumbosacral Spine. Cureus. 2020 Jul 28;12(7):e9433. doi: 10.7759/cureus.9433.

  PMID: 32864257 RESULT

Related Links

• Acute Postoperative Pain: Patient-Controlled Analgesia
• Caudal epidural steroid injection ultrasound-guided versus fluoroscopy-guided in treatment of refractory lumbar disc prolapse with radiculopathy

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fentanyl; Propofol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Tarek Monir, Professor

  Anesthesiology, Intensive care, and Pain Management, Faculty of Medicine, Al-Azhar University

  STUDY CHAIR

Central Study Contacts

Mohamed Khalil, Resident

CONTACT

+201001297071; khalil.mohamed24mkh@gmail.com

Othman Yahia, Lecturer

CONTACT

+201001297071; khalil.mohamed24mkh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cairo,Egypt

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

EG (1)