Efficacy and Duration of Pain Relief in Transforaminal and Lumbar Sympathetic Blocks

NCT06438952 | Recruiting

• 1 other identifier: E.142568
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Low back pain is a symptom that is frequently seen in the general population and reduces the quality of life of patients. Conventional medical treatment for patients with low back pain includes oral medication, lifestyle modification, education, exercises, lumbar traction and manual manipulation, heat application, and other interventional procedures. Epidural injections, one of the interventional procedures, are one of the common treatment methods for low back pain, especially caused by disc prolapse. Steroids are commonly used to reduce inflammation in the epidural space. Epidural steroid injection can be given to the lumbar epidural space via transforaminal, interlaminar and caudal routes, and the effectiveness rate of each is different. These interventional methods used to treat low back pain can be applied in combination. The main purpose of this study is to observe how adding lumbar sympathetic blockade will affect the patient's pain in the postoperative period in patients to whom we applied caudal epidural and transforaminal steroid injection.

Conditions

Low Back Pain; Lumbar Disc Herniation

Keywords

Transforaminal Steroid İnjection; Lumbar Sympathetic Blockade; Lumbar Disc Herniation; Neuropathic Pain Questionnaire; Numerical Rating Scale

Outcome Measures

Primary Outcomes (1)

• Pain intensity score

  Postoperative pain assessed with numeric rating scale (NRS 0: no pain 10:pain as bad as can be )

  Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month

Secondary Outcomes (3)

• Oswestry Disability Index (ODI)

  Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month

• Neuropathic pain questionnaire

  Preoperative and postoperative 24th hour, 1st week, 1st month and 6th month

• Patient satisfaction

  Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)

Study Arms (2)

Addition of lumbar sympathetic blockade to transforaminal steroid injection

ACTIVE COMPARATOR

The patient will receive both transforaminal steroid injection and lumbar sympathetic blockade.

Procedure: Transforaminal steroid injection combined with lumbar sympathetic blockade

Transforaminal steroid injection only

PLACEBO COMPARATOR

The patient will only receive transforaminal steroid injection.

Procedure: Transforaminal steroid injection only

Interventions

Transforaminal steroid injection combined with lumbar sympathetic blockade PROCEDURE

Transforaminal steroid injection will be made with 2 mg dexamethason + 20 mg lidocaine + 5mg bupivacaine + 5 mcg fentanyl + 100mg magnesium under US-guidance Lumbar sympathetic blockade will be made with 5 ml 0.5% bupivacaine + 6 mg dexamethason + 10 ml NaCl

Addition of lumbar sympathetic blockade to transforaminal steroid injection

Transforaminal steroid injection only PROCEDURE

Transforaminal steroid injection will be made with 2 mg dexamethason + 20 mg lidocaine + 5mg bupivacaine + 5 mcg fentanyl + 100mg magnesium under US-guidance

Transforaminal steroid injection only

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II-III
• Patients who underwent facet joint injection and transforaminal injection due to lumbar disc herniation

You may not qualify if:

• Patients with known allergies to the drugs to be used in treatment
• Infection near the puncture site
• Known coagulation disorders
• Patients with internal fixation or severe anatomical variation such as scoliosis and tumor
• History of sympathetic chemical or thermal neurolysis
• Alcohol and drug use
• Disorder of consciousness
• Liver failure, renal failure, advanced cardiac failure
• Uncontrolled diabetes mellitus
• Morbid obesity (body mass index (BMI) \> 35 kg m-2)
• Female patients during pregnancy and breastfeeding
• Not approving the informed consent form

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (2)

Aylin Ceren Şanlı

Istanbul, Turkey (Türkiye)

RECRUITING

Aylin Ceren

Istanbul, Turkey (Türkiye)

COMPLETED

MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Study Officials

• Zübeyde Özdemir

  ethics committee chairman

  STUDY CHAIR

Central Study Contacts

Zübeyde Özdemir

CONTACT

+90 2125232288; etikkurul@bezmialem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: June 3, 2024
• Study Start: June 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

TU (2)