Study of the Use of Ultrasound Scan for Lumbar Regional Anesthesia
Phase: NA
Conditions: Lumbar Ultrasound
Sponsor: 424 General Military Hospital

STYDY PROTOCOL 
 
Title: 
Study of the use of the ultrasound scan for performing lumbar regional 
anesthesia. 
Date:  
10/09/2015 
NCT02553746 
Principal investigator: Georgios Kotsovolis, Department of Anesthesia, 424 Army General 
Hospital, Thessaloniki, gskotsos@gmail.com 
 
OBJECTIVE 
The main objective of the study is to evaluate if the ultrasound scan of the lumbar 
spine can facilitate the performance of spinal, epidural or combined spinal-epidural 
anesthesia, increase the success rate of these techniques and decrease the complication 
rate.  
 
MATERIAL AND METHODS 
Participants 
Number: 80 
The patients will be allocated to 2 groups. According to data from other similar 
studies, 40 patients in each group are required to reach statistically significant results with 
p=0,05 and power 80%. 
 
Origin: 
The patients scheduled for surgery under spinal, epidural or combined spinal-
epidural anesthesia will participate in the study. Enrollment will begin at 10th September 
2015 and will finish when the number of 80 participants is reached. 
 
Inclusion criteria: 
 Written consent to participate in the study signed by the patient. 
 Surgery under spinal, epidural or combined spinal-epidural anesthesia. 
 ASA 1-3. 
 Age 18-80 years. 
 

Exclusion criteria: 
 Contraindication for regional anesthesia. 
 History of lumbar spine surgery.  
 
 
Materials 
 27G pencil-point spinal needles atraumatic (Pencil Point). 
 18G Tuohy needles and epidural catheters. 
 Combined spinal-epidural sets. 
 Ultrasound scanner Sonoscape S6. 
 
METHOD 
 
Type of study 
Prospective, randomized controlled trial. 
 
Procedure  
 
The 80 patients will be allocated to two groups (40 patients in each group). In the 
first group (Group U), the needle entry point for the regional anesthesia will be 
determined by ultrasound scan of the lumbar spine. In the other group (Group L), the 
traditional landmarks technique will be applied. The two groups will be compared to 
examine if there is difference in success rate, first-try success rate, number of punctures 
and time required to compete the technique and complication rate.  
 
Randomization 
The randomization will be done by software (www.randomizer.org). 
 
Anesthesia – Perioperative management 
500ml Ringer's Lactate will be given intravenously to all patients before the 
performance of the regional technique and all the usual monitoring devices will be 
applied. The regional anesthesia will be done with the patients placed in the sitting 
position via the medial approach. After locating the needle entry point, the skin will be 

infiltrated with 3ml of lidocaine. The loss of resistance technique with a saline-filled 18G 
Tuohy needle will be used for identifying the epidural space.  
 
Interventions 
In Group L patients, the traditional landmarks techniques will be applied to 
determine the puncture point. At the level of the Toiffier line, the spinous process of the 
L3 or the L4 vertebrae will be identified by palpation. In Group U patients, the needle 
entry point will be located after ultrasound scan of the lumbar spine according to the 
technique described by Arzola et all. The ultrasound probe will be placed perpendicular 
to the vertebral column and will be moved cranially and caudally until the acoustic 
shadow of the spinous process disappears and the intervertebral space is revealed. Pen 
marks will be drawn in the middle of the upper and lateral side of the probe and the 
crossing of the two marks will be the entry point. Before the enrollment of patients in the 
study, the ultrasound technique will be tested on 20 patients. All the regional anesthetics 
will be performed by the same anesthesiologist. 
 
Outcomes 
The primary outcomes are:  
1) Success of the technique (yes/no). 
2) First try success (yes/no). 
3) Number of punctures required. 
4) Frequency of modifications of the trajectory of the needle.  
5) Change of puncture level (yes/no). 
6) Time required to complete the technique.  
 
Secondary outcomes: 
1) Lumbar spine pain (yes/no). 
2) Lumbar spine pain score (VAS 0-10).  
3) Patient satisfaction. 
4) Complications. 
 
In cases of spinal anesthesia, the technique will be considered successful if the 
patient has any degree of sensory block. In cases of epidural or combined spinal-epidural 

anesthesia, the technique will be considered successful if the epidural catheter is 
confirmed to be in the epidural space. The puncture level will be changed after 4 
unsuccessful attempts. The time required to complete the technique will be recorded by 
the time the patients takes the sitting position until the end of the injection of the local 
anesthetic (spinal anesthesia) or the confirmation of the placement of the epidural 
catheter. Lumbar spine pain will be evaluated 12 και 24 hours after the end of the 
regional anesthetic with 11-degree Numerical Rating Scale (NRS 0-10). Satisfaction from 
the anesthetic technique will be evaluated by the patient (Yes/Not completely/NO) and he 
will be asked if he would choose the same anesthetic technique again in the future 
(YES/NO). 
 
Data recording 
Data will be recorded according to the attached case form. Apart from the main 
parameters, the age, weight and height of each patient and the type of surgery will be 
recorded. 
 
Statistics 
For the comparison of the groups the chi square statistical test will be applied for the 
following variables: 
1) 
Success of the technique (Yes/No). 
2) 
Success on first attempt (Yes/No). 
3) 
Change of puncture level (Yes/No). 
4) 
Back pain (Yes/No). 
For the rest of the variables (attempts required to complete the technique, number of 
changes of the trajectory of the needle, time required to complete the technique, back pain 
score, patient satisfaction), the normality of distribution will be tested with the Kolmogorov-
Smirnov test. If the data have normal distribution, the student's t-test will be used and if not, 
the Wilcoxon signed rank test. The SPSS 15.0 software will be used. 
 
Intermediate assessment 
6 months after the beginning of the study an intermediate assessment will be performed 
and the study will be terminated if any serious complications are documented. 
 
 

Ethics 
The study protocol will be eavaluated by the ethics committee of 424 Army General 
Hospital of Thessaloniki. 
 
Financial issues 
No additional financial support is required for the completion of the study. 
 
Benefits 
With this study we will investigate if the use of the ultrasound, a device with very low 
cost of use and no complications, can facilitate the performance of lumbar regional anesthesia. 

 
       Months 
 
Tasks 
09/15 10/15 11/15 12/15 01/16 02/16 03/16 04/16 05/16 06/16 07/16 08/16 09/16 10/16 
Study  
 
Data collection 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
Data summary 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Statistics 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Results 
presentation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Timetable