Analgesic Efficacy of Bilateral Erector Spinae Plane Block in Pediatric Tethered Cord Syndrome Surgery: A Prospective, Randomized Controlled Trial
Phase: NA
Conditions: Erector Spina Plan Block
Sponsor: Bursa Yuksek Ihtisas Training and Research Hospital

08.04.2025 
RESEARCH PROTOCOL            
ULTRASOUND-GUIDED BILATERAL ERECTOR SPINACH PLANE BLOCK FOR POSTOPERATIVE PAIN IN 
PEDIATRIC TETHERED CORD SYNDROME SURGERY: A PROSPECTIVE, RANDOMIZED CONTROLLED 
STUDY 
Contents 
1. Introduction 
2. Aim 
3. Hypothesis 
4. Phase and Nature of the Study 
5. Study Population 
6. Inclusion Criteria 
7. Exclusion Criteria 
8. Study Center 
9. Study Duration 
10. Materials and Methods 
11. Research Budget 
12. Ethics Committee Approval 
13. Statistics 
14. References 
 
1.Giriş                                                                                                               
Tethered cord syndrome is a developmental anomaly of neuroaxis characterized by stretching of the 
spinal cord. It is frequently seen and diagnosed in the pediatric age group due to the presence of 
many accompanying skin findings (meningocele, meningomyelocele, hypertrichosis, dermal sinus 
tract, subcutaneous lipoma, etc.). Surgical release of the tight and bound filum terminale is 
performed. Intraoperative neurophysiological monitoring (IONM) is used to preserve functional 
nerve tissue and prevent postoperative neurological deficits. Total intravenous anesthesia (TIVA-TCI) 
with propofol and remifentanil is used to ensure accurate measurements. 
Postoperative pain is acute pain caused by surgical trauma and signal transmission in afferent 
neurons. Pediatric postoperative pain is associated with adverse behaviors, prolonged hospital stay, 

and impaired functional recovery. Despite good progress in pain management, ineffective 
postoperative pain management in children remains a global problem. Regional anesthesia is 
increasingly used in pediatric patients to provide postoperative analgesia and support intraoperative 
anesthesia. Ultrasound-guided erector spinae plane block (ESPB) is a new approach. First introduced 
in 2016 by Forero et al., ESPB is a novel regional anesthesia technique that blocks branches of spinal 
nerves by injecting a local anesthetic into the fascial plane between the erector spinae muscle and 
the transverse process. Although new, ESPB has become quite popular due to its ease of application 
and reliability as a relatively superficial block. Initially, ESPB was defined for chronic pain from the 
thoracic region. Later, its indications expanded and it is now used in both acute and chronic pain 
conditions. Applications have also been reported in the lumbar, cervical, and sacral regions, 
respectively. In recent years, an increasing number of randomized controlled trials (RCTs) have 
reported that it provides effective postoperative analgesia for thoracic surgeries, nephrectomy, 
inguinal hernia repair, and laparoscopic cholecystectomy operations in children. In our study, we 
planned to evaluate the effect of bilateral ESPB on intraoperative anesthetic drug consumption and 
postoperative pain score and analgesia requirement in pediatric patients operated on due to 
tethered cord syndrome. 
2. Objective 
In our study, we aimed to reduce intraoperative anesthetic drug consumption and the level of pain in 
the first 24 hours postoperatively, the need for analgesics, and unwanted side effects related to 
analgesics by applying bilateral ESPB in pediatric patients operated on due to tethered cord 
syndrome. 
3. Hypothesis 
Bilateral ESPB reduces intraoperative anesthetic drug consumption and the need for postoperative 
analgesia in pediatric patients operated on due to tethered cord syndrome. 
4. Study Phase and Nature 
Low-risk scientific study - Prospective randomized controlled single-blind clinical trial 
5. Study Population 
Pediatric patients undergoing surgery for elective tethered cord syndrome 
6. Inclusion Criteria 
• Patients whose parents consented to participate in the study 
• Patients aged 18 and under 
 
• ASA (American Society of Anesthesiologists) physical status I, II, and III 
• Pediatric patients undergoing elective tethered cord syndrome surgery 
7. Exclusion Criteria 

• Patients whose parents did not consent to participate in the study 
• Patients with ASA physical status IV and V 
 
• Use of anticoagulant medications 
• Allergy to local anesthetic drugs 
 
• Patients with a history of gastrointestinal bleeding 
• Patients with infection in the area where the block is planned 
8. Study Center 
Health Sciences University Bursa High Specialization Training and Research Hospital Anesthesiology 
and Reanimation Clinic 
9. Study Duration 
1 year 
10. Material – Method 
Patients included in the study will be divided into 2 groups according to the randomized (closed 
envelope) sampling method; Erector Spina Plane Block (ESPB, n=34) group and Control group (CG, 
n=34). Patients who regularly take medication due to cardiovascular or other systemic diseases will 
continue their medication. Those whose coagulation parameters are checked before the operation 
and are normal will be included in the study. 
The patients' age, height, weight, gender, additional diseases, ASA scores, operation and anesthesia 
duration, operation level, level of block performed in the group undergoing ESP block, and total 
anesthetic drug consumption will be recorded. Standard ECG, SpO2, non-invasive blood pressure 
(invasive blood pressure monitoring in necessary cases), EtCO2 and BIS monitoring will be applied in 
the operating room. After appropriate intravenous access is established in both groups of patients, 
anesthesia induction will be achieved with 2 mg/kg propofol (Propofol 2%®, FreseniusKabi, 
Melsungen, Germany), 1 μgr/kg fentanyl (Fentanyl Citrate®, Hospira, USA), and 0.6 mg/kg 
rocuronium (Esmeron®, Organon, Kloosterstraat, Netherlands). Following intubation, anesthesia 
maintenance will be administered with a 2 l/min flow rate of 50/50 O2/air mixture. Inhalation 
anesthetics will not be used, and no additional doses of muscle relaxants will be given. 
Neuromonitoring will be performed on all patients by the neurosurgical team following intubation. 
Patients will be turned to the prone position once they are stable. For total intravenous anesthesia in 
patients undergoing neuromonitoring-based anesthesia maintenance, propofol will be infused at an 
initial target plasma concentration of 2.5-4 µg.ml -1 (Medcaptain Shenzhen, Guangdong, CHINA, 
Elevated model FK/FD). Remifentanil (ULTIVA®, GlaxoSmithKline Parma, Italy) will be infused at a rate 
of 0.5-1 µg/kg/min. Infusions will be maintained to maintain a BIS of 40-60. Preoperative, 

peroperative 5th, 10th, 15th, 30th, 60th, 90th, 120th, 180th minute, and post-extubation heart rate, 
supravascular pressure, intravascular pressure, SpO2, ETCO2, and BIS values will be recorded. 
Patients will be randomly assigned to two separate groups using a sealed envelope method, 
regardless of their demographic and surgical characteristics. In the ESP Block group, with the patient 
in the prone position, the research anesthesia team, following aseptic and antiseptic rules, will insert 
a linear probe (Hitachi Aloka Prosound F31) with a depth of 2-4 cm and a frequency of 10-15 mHz, 
approximately 2-3 cm lateral to the spinous process, one level above the operative level, in the 
parasagittal plane, under USG guidance (Hitachi Aloka Prosound F31). After visualizing the transverse 
process using an in-plane approach, a 50 mm long block needle (Braun Stimuplex® D 0.22 Gax2 
in.50mm, Braun, Germany) will be inserted through the skin, passing through the trapezius and 
erector spinae muscles. When the needle reaches the transverse process (approximately 2-3 cm 
deep), a test dose of 0.5-1 mL of 0.9% NaCl will be administered between the erector spinae fascia 
and the vertebral transverse process to confirm the needle's position. After the fascia is seen to be 
open, a local anesthetic volume of 0.5% bupivacaine (Buvasin, VEM Pharmaceuticals, Turkey) will be 
calculated as 2 ml per vertebral pressure, not exceeding a maximum dose of 2 mg/kg. This total 
volume will be diluted half and half with 0.9% NaCl solution to prepare a 0.25% bupivacaine 
concentration. The calculated local anesthetic solution will be administered to the erector spinae 
area for ESPB. The same procedures will be performed on the opposite side. No procedure will be 
performed on the control group. Both groups will receive 15 mg/kg Paracetamol (Parol®, ATABAY, 
Kurtköy, Pendik, Istanbul) intravenously 20 minutes before the end of surgery. After surgery, patients 
will be decurarized with 2 mg/kg IV sugammadex (Bridion, MerckSharpDohme, New Jersey, USA), 
extubated, and taken to the recovery unit. After being admitted to the recovery room, both groups 
will be assessed using the Wong-Baker FACES™ Pain Rating Scale for children under 5 years old and 
the FLACC: Pain Rating Scale for children 5 years and older, with pain scores at 0, 5, 10, 15, and 20 
minutes. Patients with scores >5 will receive 0.5 mcg/kg fentanyl (TALİNAT®, VEM İlaç, 
Kapaklı/TEKİRDAĞ) for rescue analgesia. Paracetamol 15 mg/kg/6 hours will be administered 
intravenously for postoperative analgesia. A blinded investigator will assess patients' pain scores, 
analgesic requirements, names of analgesics administered, and nausea/vomiting at 30 minutes, 1, 2, 
4, 6, 12, and 24 hours postoperatively. The time and dose of the first postoperative analgesic, and 
length of hospital stay will be recorded. 11. Research Budget 
The cost of 34 block needles and 34 doses of the drug buvasin containing the active ingredient 
bupivacaine for one patient has been submitted with a propharmaceutical invoice. The expenses will 
be covered by the researchers. 
12. Ethics Committee Approval 
An application has been submitted for ethics committee approval. 
13. Statistics 
Statistical analyses of the obtained data will be performed using the IBM SPSS Statistics 21.0 
software package. Descriptive statistics of the data will include mean, standard deviation, frequency, 
and percentage values. Chi-square and FischerExact tests will be used for the analysis of categorical 
variables. The normality assumption of continuous numerical variables will be checked separately in 
groups using the Shapiro-Wilk test. Analysis of variance (ANOVA) will be used for independent group 

comparisons of numerical variables showing normal distribution. Kruskal-Wallis (KW) test will be 
used for variables that do not show normal distribution. For comparisons of consecutive 
measurements, the Wilcoxon Signed Ranks test will be used for pairs of measurements, the Friedman 
test for more than two measurements, and the Pearson correlation test will be used as a correlation 
test. The significance level will be set at p<0.05 in all analyses. The required sample size for the study 
was calculated as 68 (34+34) patients in total, including the group that underwent ESPB and the 
group that did not undergo ESPB, with an effect size of 0.70, 80% test power, and 95% confidence 
level. The relevant calculations were made in the G-Power 3.1.9.2 software package. 
14. References 
1. Gado, A. A., Alsadek, W. M., Ali, H., & Ismail, A. A. (2022). Erector spinae plane block for children 
undergoing cardiac surgeries via sternotomy: a randomized controlled trial Anesth Pain Med. 
2022;12(2):e123723. doi: 10.5812/aapm-123723. PMID: 35991776 
2. Aksu, C., & Gürkan, Y. (2018). Ultrasound guided erector spinae block for postoperative analgesia 
in pediatric nephrectomy surgeries. J Clin Anesth. 2018 Mar:45:35-36 doi: 
10.1016/j.jclinane.2017.12.021. Epub 2017 Dec 20. PMID: 29274546 
3. Domagalska, M., Ciftsi, B., Janusz, P., Reysner, T., Daroszewski, P., Kowalski, G., ... & Kotwicki, T. 
(2024). Effectiveness of the bilateral and bilevel erector spinae plane block (espb) in pediatric 
idiopathic scoliosis surgery: a randomized, double-blinded, controlled trial. Journal of Pediatric 
Orthopedics, 10-1097. doi: 10.1097/BPO.0000000000002707 
4. Thomas, D. T., & Tulgar, S. Ultrasound-guided erector spinae plane block in a child undergoing 
laparoscopic cholecystectomy. Cureus 2018; 10 (2): e2241. Epub 2018/05/03. doi: 10.7759/cureus. 
2241. PubMed PMID: 29719743. 
5. Aksu, C., & Gurkan, Y. (2019). Defining the indications and levels of erector pediatric spinae plane 
block in patients: a retrospective study of our current experience. Cureus, 11(8). doi: 
10.7759/cureus.5348 PMID: 31602352 
6. Lucente, M., Ragonesi, G., Sanguigni, M., Sbaraglia, F., Vergari, A., Lamacchia, R., ... & Rossi, M. 
(2022). Erector spinae plane block in children: a narrative review. Korean Journal of Anesthesiology, 
75(6), 473-486. doi: https://doi.org/10.4097/kja.22279 
7. Luo, R., Tong, X., Yan, W., Liu, H., Yang, L., & Zuo, Y. (2021). Effects of erector spinae plane block on 
postoperative pain in children undergoing surgery: A systematic review and meta‐analysis of 
randomized controlled trials. Pediatric Anesthesia, 31(10), 1046-1055.doi: 10.1111/pan.14255