- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02343432
Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections?
Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections? :A Randomised, Clinical Trial
This study was aimed to investigate the impact of using different epidural volumes.
Patients with acute discogenic pain were included in the study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objectives: This study was aimed to investigate the impact of using different epidural volumes.
Methods: Seventy five patients with acute discogenic pain were included in the study.The patients were randomly assigned to three groups. All patients received a single epidural dose of triamcinolone [80 mg] and 12.5 mg bupivacaine combination. The patients in Group 1, Group 2 and Group 3 received a volume of 10 mL, 15 mL, and 20 mL by epidural injections, respectively. The efficacy of treatment was assessed with VAS (visual analog scale) [O= no pain, 10 = unbearable pain], SLET(straight leg elevation test) [0° = worst, 85° = best], and Oswestry Disability Index; ODI [0% to 20%:minimal disability , 80% to 100%:bed bound patients] before and 2 weeks after the EPSI.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- acute discogenic pain with less than three months duration not responding to other modalities of conservative management [NSAIDs, physiotherapy, bracing, etc.],
- radiological disc bulging accompanying unilateral root impingement symptoms,
- an Oswestry daily activity score more than 20 percent, and
- resistance to treatment.
Exclusion Criteria:
- Patients with bilateral root impingement symptoms, neurological deficits, and/or history of previous lumbar disc surgery, severe cardiac, pulmonary, gastrointestinal, renal diseases, glaucoma, urinary retention, and/or known allergy to the drugs used in the study were excluded from the study.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Epidural Volume 10mL
Epidural Volume 10mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 10mL Intervention: Drug: Bupivacaine 12.5mg
|
Bupivacaine
Other Names:
Triamcinolone
Other Names:
Epidural Volume
|
Experimental: Epidural Volume 15mL
Epidural Volume 15mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 15 mL Intervention: Drug: Bupivacaine 12.5mg
|
Bupivacaine
Other Names:
Triamcinolone
Other Names:
Epidural Volume
|
Experimental: Epidural Volume 20mL
Epidural Volume 20mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 20 mL Intervention: Drug: Bupivacaine 12.5mg
|
Bupivacaine
Other Names:
Triamcinolone
Other Names:
Epidural Volume
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
VAS (visual analog scale) [O= no pain, 10 = unbearable pain]
Time Frame: 2 weeks
|
2 weeks
|
SLET(straight leg elevation test) [0° = worst, 85° = best]
Time Frame: 2 weeks
|
2 weeks
|
Oswestry Disability Index; ODI [0% to 20%:minimal disability , 80% to 100%:bed bound patients]
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Lütfiye Budak, University of Gaziantep
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-2008/23
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.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Bupivacaine
-
Hospital Civil de GuadalajaraRecruitingEffect of Subarachnoid Hyperbaric Bupivacaine in Obese Pregnant Patients Undergoing Cesarean SectionAnesthesia | Obstetric Anesthesia ProblemsMexico
-
Hospital Civil de GuadalajaraCompletedAnesthesia, ObstetricalMexico
-
DurectNycomedCompletedPostoperative PainAustria, Germany, Latvia, Poland, Sweden
-
DurectNycomedCompletedPostoperative PainFrance, Germany, Hungary, Latvia, Sweden, United Kingdom
-
Indiana UniversityCompletedPain, Postoperative | Acute Pain | ThoracicUnited States
-
Seoul National University HospitalUnknownAnesthesia, Spinal [E03.155.086.331] | Operating Tables [E07.325.662]Korea, Republic of
-
Vanderbilt University Medical CenterCompletedAnesthesia | Breast Reconstruction | Transverse Abdominis Plane BlockUnited States
-
Indiana UniversityCompleted
-
Coordinación de Investigación en Salud, MexicoInstituto Mexicano del Seguro SocialCompletedObstetric PainMexico
-
University of Texas Southwestern Medical CenterCompleted