Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Medial vs Lateral in Anteroposterior View

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02867046
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious complication can be developed. Against this backdrop, if there is any difference of frequency of intravascular injection incidence during S1 (sacrum 1) TFESI between method using medial approach and method using lateral approach in anteroposterior view, the result can be crucial factor in selecting the approach. In addition, appropriate volume of injection will be checked in each approach.

Condition or disease Intervention/treatment Phase
Lumbosacral Radicular Pain Drug: S1 transforaminal epidural steroid(dexamethasone) injection Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Actual Study Start Date : July 29, 2016
Actual Primary Completion Date : November 28, 2016
Actual Study Completion Date : November 28, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: medial approach group Drug: S1 transforaminal epidural steroid(dexamethasone) injection

medial approach group (n=85): check intravascular injection while performing S1 transforaminal epidural steroid(dexamethasone) injection in medial side of S1 foramen under fluoroscopy

lateral approach group (n=85): same as medial approach group except using lateral side of S1 foramen


Active Comparator: lateral approach group Drug: S1 transforaminal epidural steroid(dexamethasone) injection

medial approach group (n=85): check intravascular injection while performing S1 transforaminal epidural steroid(dexamethasone) injection in medial side of S1 foramen under fluoroscopy

lateral approach group (n=85): same as medial approach group except using lateral side of S1 foramen





Primary Outcome Measures :
  1. the incidence of intravascular injection in the medial approach group in S1 foramen [ Time Frame: 5 seconds after injection of contrast media via block needle. ]
  2. the incidence of intravascular injection in the lateral approach group in S1 foramen [ Time Frame: 5 seconds after injection of contrast media via block needle. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Adult patients (20-80 years of age) who were scheduled to receive S1 transforaminal epidural steroid injection for lumbosacral radicular pain at pain management clinic

Exclusion Criteria:

  1. pregnancy
  2. coagulopathy
  3. systemic infection
  4. any active infection at the injection site
  5. history of allergy to contrast media, local anesthetics, corticosteroid
  6. patients unable to communicate or patients with cognitive dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867046


Locations
Layout table for location information
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02867046     History of Changes
Other Study ID Numbers: 4-2016-0442
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action