Clinical Efficacy of Local Anesthetic Agents With Interlaminar Epidural Steroid Injection for Chronic Neck Pain: A Prospective, Observational Study
Conditions: Chronic Neck Pain
Sponsor: Mustafa Kurçaloğlu

(Date of the document: 08.01.2021) 
Title of the manuscript: Clinical Efficacy of Local Anesthetic Agents with Interlaminar 
Epidural Steroid Injection for Chronic Neck Pain: A Prospective, Observational Study 
 
STUDY PROTOCOL AND STATISTICAL ANALYSIS 
 
 
Patients who were planned to have a cervical epidural injection due to the pain originated from 
intervertebral disc herniation following examination at the Algology Clinic between 01.01.2022 
and 07.30.2022 were included in the study.  Patients younger than18, those who were unwilling 
to participate, those who were pregnant or possibly pregnant, with infection or anatomic 
variations in the region of the procedure, allergic to the drugs to be used in the procedure and 
with coagulation disorders were excluded from the study 
Demographic data including age and sex, comorbidities, duration of symptoms, and 
surgical history of the cervical disk were recorded. The hallmarks of cervical disk hernia as 
evidenced by magnetic resonance imaging (MRI) were documented.  
To assess pain severity and functional status, the Numerical Rating Scale (NRS) and the 
Neck Disability Index (NDI) were used. Treatment success was defined as ≥50% reduction in 
NRS  at one, three, and six months during follow-up.  
Operative technique 
Cervical ESIs were performed under the guidance of C-arm fluoroscopy imaging by 
algology specialists with at least five years of experience. An intravenous access was opened 
with the aim of managing possible complications and side effects. In the operating room, the 
patient was placed in prone position on the procedure table and a pillow was placed under the 
chest to ensure the head was in flexion position. The region of the procedure was cleaned with 
antiseptic solution (povidone-iodine complex) and covered with a sterile drape. Local 
anesthesia was administered to the region with 3 cc 2% lidocaine to skin and subdermal tissue 
and patients were left for at least 2 min. The epidural intervention was performed through the 
C7-T1 interlaminar space with the ‘loss of resistance technique’ using an 18-gauge Tuohy 
needle. Contralateral oblique images were obtained with the aim of checking the depth of the 
needle tip. When loss of resistance was felt, a 0.5 to 2 mL contrast agent was administered and 

the spread of the contrast material in the epidural space was observed and possible intravenous 
and subdural/intrathecal spread was excluded. After the needle was ensured to be in the correct 
position, Group S were administered 6 mg betamethasone (Celestone®, Merck Sharp Dohme 
İlaçları Ltd. Şti, İstanbul, Türkiye) (1 mL) and 4 mL physiological saline for a 5 mL total 
injection. Group SLA were administered 6 mg betamethasone (Celestone®) (1 mL), 5 mg 0.5% 
bupivacaine (Marcaine®, AstraZeneca İlaç Sanayi Ltd. Şti, İstanbul, Türkiye) (1 ml) and 3 mL 
physiological saline for a 5 mL total injection. After the procedure, all patients were monitored 
for at least 2 hours and then discharged. The patients were assessed before the procedure and 
in the first week and at one, three and six months after the procedure.  
Statistical Analysis 
Study power analysis and sample size calculation were performed using the G*Power 
version 3.1.9.2 software (Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany). Using 
an alpha value of 0.05 and study power 0.95, the number of patients to be included in the sample 
was 30 patients in the study group and 30 patients in the control group, as prescribed by 
Manchikanti et al. (8). Finally, a total of 60 patients who met the inclusion criteria were 
recruited. The patients were divided into two groups as those administered steroids and local 
anesthetics (Group SLA, n=30) with ESI and those only given steroids (Group S, n=30).  
Statistical analysis was performed using the SPSS version 27.0 software (IBM Corp., 
Armonk, NY, USA). Continuous data were presented in mean ± standard deviation (SD) or 
median (min-max), while categorical data were presented in number and frequency. The 
Student t-test was used to compare normally distributed variables for independent groups, while 
the Mann-Whitney U test was used to analyze non-normally distributed variables. The 
dependent groups t-test was used to analyze data with a normal distribution, while the Wilcoxon 
signed-rank test was applied to data that did not follow a normal distribution, both before and 
after the implementation. The Pearson or Spearman correlation analyses were used to examine 
possible correlations between scale scores and demographic data. A p value of <0.05 was 
considered statistically significant.