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

March 22, 2024 updated by: Mohamed Khalil Elsayed Khalil, Al-Azhar University

Comparison Between Ultrasound-Guided Erector Spinae Plane Block Versus Ultrasound-Guided Caudal Injection in Lumbosacral Spine Surgeries for Postoperative Pain Management

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Major lumbosacral surgery results in considerable postoperative discomfort that normally lasts at least three days. According to several research, the most discomfort occurs in the first four postoperative hours and gradually decreases by the third postoperative day. Efficient and safe postoperative analgesic treatments following lumbosacral surgery are useful for early recovery and hence required.

Traditional caudal epidural injections, on the other hand, pose a potential risk of epidural venous plexus or dura penetration, with the incidence of accidental intravascular injections, as confirmed by contrast enhanced fluoroscopy, ranging from 11 to 42% in patients who had received caudal epidural injections. Furthermore, there have been a few instances of unintended Dural puncture during the caudal approach because of an unusually low Dural sac termination in the sacral canal.

Such complications of intravascular and intrathecal drug injections might result in systemic toxicity of local anesthetics and complete spinal anesthesia. Thus, ultrasonography (US) can be utilized to guide caudal injections, increasing the efficacy of pain treatment while decreasing the risk of complications and incorrect injections. Previous investigations shown the feasibility of using ultrasound to locate the sacral hiatus and guide the needle into the caudal epidural area, with a reported success rate of 100%.

Another technique for postoperative pain relief is the Erector spinae plane block (ESPB), which was introduced in 2016. It is a relatively new regional anesthesia technique in which local anesthetic is injected into the fascial plane between the transverse process of the vertebra and the erector spinae muscles. It has acquired favor in perioperative analgesia for a variety of surgical procedures, including breast, thoracic, abdominal, and lumbar spine operations.

The addition of US to ESPB allows the needle to be guided to efficiently deposit the anesthetic agents deep to the erector spinae muscle, resulting in the blockage of the ventral and dorsal rami of many spinal neurons, boosting the efficiency of pain control.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A ( Erector Spinae Plane Block)
About 40 patients who will be subjected to Ultrasound-Guided Erector Spinae Plane Block.for Postoperative Pain Management
Drug: Fentanyl
to compare between Ultrasound-Guided ESPB and Ultrasound-Guided CEI for postoperative pain relief in patients who underwent lumbosacral surgeries.
Other Names:
  • propofol 2Mg/Kg
Active Comparator: Group B (Caudal Injection)
About 40 patients who will be subjected to Ultrasound-Guided Caudal Injection in Lumbosacral Spine Surgeries for Postoperative Pain Management
Drug: Fentanyl
to compare between Ultrasound-Guided ESPB and Ultrasound-Guided CEI for postoperative pain relief in patients who underwent lumbosacral surgeries.
Other Names:
  • propofol 2Mg/Kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Post-operative Pain
Time Frame: the first 24 hours postoperatively
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Study Chair: Tarek Monir, Professor, Anesthesiology, Intensive care, and Pain Management, Faculty of Medicine, Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESPB versus CEI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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