The Effect of Bilateral Erector Spina Plan Block Performed After Lumbar Spinal Stabilization Surgery on Postoperative Patient Recovery and Pain
Phase: NA
Conditions: Erector Spina Plan Block
Sponsor: Bursa Yuksek Ihtisas Training and Research Hospital

25.06.2024 
RESEARCHPROTOCOL 
 
 
Theeffectofbılateralerectorspınaplanblockperformedafterlumbarspınalstabılızatıonsurgeryon 
postoperatıve patıent recovery and paın 
 
 
 
 
Contents 
 
 
1. Introduction 
2. Aim 
3. Hypothesis 
4. PhaseandNatureoftheStudy 
5. StudyPopulation 
6. InclusionCriteria 
7. ExclusionCriteria 
8. StudyCenter 
9. StudyDuration 
10. MaterialsandMethods 
11. ResearchBudget 
12. EthicsCommitteeApproval 
13. Statistics 
14. References 

 
 
 
1. Introduction 
 
 
Patients undergoing lumbar spinal stabilization surgery may experience severe postoperative pain 
lastingatleastthreedays.Analgesiaafterlumbarstabilizationsurgeryisbeneficialforearlyrecovery and is 
therefore necessary. However, traditional opioid-based analgesic techniques; It is associated with 
many undesirable effects, including nausea, vomiting, itching, and sedation. Inadequate 
postoperative pain control also has many side effects on physiological systems such as the 
cardiovascular, pulmonary, gastrointestinal, immunological, renal, and hematological systems. 
Furthermore,inadequatepostoperativepaincontrolincreaseshospitalstay,mortalityandmorbidity, 
prolongs patient ambulation time, increases patient costs, reduces patient satisfaction, and can lead 
to the development of chronic postoperative pain. Nonsteroidal anti-inflammatory drugs (NSAIDs), 
opioid analgesics, and local anesthetics are frequently preferred options for providing postoperative 
analgesia. In cases where these agents are insufficientto prevent pain, regionaltechniques areoften 
preferred to reduce the need for opioids. Erector spina plane block (ESPB), a component of 
multimodal analgesia andoneof the regional techniques, wasfirst used byForero et al. for analgesic 
purposes in thoracic neuropathic pain and later gained popularity. Although ESPB is frequently 
performed at the thoracic level, its use continues to increase today. 
2. Objective 
Theaimofourstudywasto reducethepainlevelsandanalgesicconsumptionofpatientsinthefirst 24 hours 
after surgery by applying bilateral ESPB postoperatively in patients undergoing lumbar spinal 
stabilization surgery, to ensure early ambulation of patients, to reduce unwanted side effects related 
to analgesics, and to reduce hospital stay durations. 
3. Hypothesis 
Bilateralerectorspinae plane block performed after lumbar spinal stabilization surgery reduces the 
needforpostoperativeanalgesicsandshortensthepatient'sambulationandhospitalstayduration. 
4. StudyPhaseandNature 
PhaseIVclinicaltrial-Prospectiverandomizedcontrolledsingle-blindclinicaltrial 
5. StudyPopulation 
Patientsundergoingelectivelumbarstabilizationsurgery 
6. InclusionCriteria 
• Patientswhovolunteertoparticipateinthestudy 
• Patientsaged18-65years 

• ASA(AmericanSocietyofAnesthesiologists)physicalstatusI,II,andIII 
• Patientsundergoingelectivelumbarstabilizationsurgery 
7. ExclusionCriteria 
 
 
• Patientswhodidnotconsenttoparticipateinthestudy 
• PatientswithASAphysicalstatusIVandV 
 
 
• Useofanticoagulantmedications 
 
 
• Allergytolocalanestheticdrugs 
 
 
• Patientsundergoinglumbarstabilizationsurgeryatlevelthreeorhigher 
 
 
• Patientswithahistoryofgastrointestinalbleeding 
 
 
• Patientswithahistoryofpsychiatricillness(MajorDepression,Schizophrenia,BipolarAffective 
Disorder) 
 
 
• Patientswithnarcoticand/oralcoholdependence 
• Patientswithahistoryofcentraland/orperipheralneurologicaldisease 
8. StudyCenter 
AnesthesiologyandReanimationClinic,BursaHighSpecializationTrainingandResearchHospital, Health 
Sciences University 
9. StudyDuration 
6months 
 
 
10. Material–Method 

Patients included in the study will be divided into 2 groups of 24 each according to the randomized 
(closedenvelope)samplingmethod;ErectorSpinaPlaneBlock(ESPB,n=24)groupandControlgroup (CG, 
n=24). Patients who regularly take medication due to cardiovascular or other systemic diseases will 
continue their medication. Coagulation parameters will be checked before the operation, and those 
with normal parameters will be included in the study. Patients included in the study will be given 
information about NRS during the preoperative evaluation. The patients' age, height, weight, gender, 
additionaldiseases, ASA scores, operationand anesthesiaduration,operation level,and the level of 
block performed in the group that underwent ESP block will be recorded. Standard ECG, SpO2, non-
invasive blood pressure (invasive blood pressure monitoring in necessary cases), and EtCO2 
monitoring will be performed in the operating room and will be performed before induction, after 
induction, at 5, 10, 15, 30, 60, 90, 120, 180 minutes, and at the end of anesthesia. 
The patients will be registered. After appropriate intravenous access is established in both groups, 
anesthesia induction will be achieved with 2 mg/kg propofol (Propofol®, FreseniusKabi, Melsungen, 
Germany), 1 μgr/kg fentanyl (Fentanyl Citrate®, Hospira, USA), and 0.6 mg/kg rocuronium(Esmeron®, 
Organon, Kloosterstraat, Netherlands). Anesthesia maintenance will be administered with a flow rate 
of2 l/min, a 50/50 O2/airmixture, and 2% sevoflurane (Sevorane®, Abbott,Chicago, USA). Patients 
will be randomly assigned to two separate groups using a sealed envelope method, 
regardlessoftheirdemographicandsurgicalcharacteristics.IntheESPBlockgroup,20mgtenoxicam 
(Tilcotil®, DEVA, Kapaklı, TEKİRDAĞ) and 1 g paracetamol (Parol®, ATABAY, Kurtköy, PENDİK, 
İSTANBUL) will be administered intravenously 30 minutes before the end of surgery. Before the 23 
patients are awakened at the end of the operation, the research anesthesia team, following aseptic 
and antiseptic rules, will perform an in-plane approach with a linear probe (Hitachi Aloka Prosound 
F31) with adepthof 2-4 cm and a frequency of10-15 mHz, positionedapproximately 3 cm lateralto the 
spinous process, one level above the operative level, in the parasagittal plane, under USG 
guidance(HitachiAlokaProsoundF31).Aftervisualizingthetransverseprocess,a100mmlongblock needle 
(Stimuplex® D0.71x80mm, 22G, Braun, Germany) will be inserted through the skin, passing through 
the trapezius and erector spinae muscles. When the needle reaches the transverse process 
(approximately 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 transverse process of the vertebra to confirm the needle's position. 
After the fascia is seen to be open, ESPB will be performed by administering a total of 20 ml of local 
anestheticsolution,consistingof 10mlof0.5% bupivacaine (Buvasin, VEMPharmaceuticals,Turkey) 
and10mlof0.9% NaCl,into theerectorspinaearea.Thesameprocedureswillbeperformedonthe opposite 
side. The control group will receive 20 mg tenoxicam (Tilcotil®, DEVA, Kapaklı, TEKİRDAĞ) and 1 g 
paracetamol(Parol®, ATABAY, Kurtköy, PENDİK, ISTANBUL) intravenously 30 minutes before the end 
of surgery. After the surgery, patients will be decurarized with 2 mg/kg IV sugammadex (Bridion, 
MerckSharpDohme, New Jersey, USA), extubated, and taken to the recovery unit. After 
beingadmittedtotherecoveryroom,bothgroupswillbeassessedforNRSscores,andpatientswith an NRS 
score >5 will receive 50 mcg of fentanyl (TALİNAT®, VEM İlaç, Kapaklı/TEKİRDAĞ) for rescue 
analgesia. 
 
 
A blinded investigator will assess patients' NRS scores, analgesic needs, names of analgesics 
administered,andnausea/vomitingat0,2,4,6,12,and24hourspostoperatively.Thetimeofthe 

firstanalgesicadministration,ambulationtime,patientsatisfaction,andlengthofhospitalstaywill 
be 
recorded. 
11. ResearchBudget 
The costof24block needles and24 dosesof bupivacaine-based medication called buvasinfor one 
patienthasbeensubmittedwithapropharmaceuticalinvoice.Theexpenseswillbecoveredbythe 
researchers. 
 
 
12. EthicsCommitteeApproval 
Anapplicationhasbeensubmittedforethicscommitteeapproval. 
13. Statistics 
Statistical analyses of the obtained data will be performed using the IBM SPSS Statistics 21.0software 
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 beused 
for variables that do not show normal distribution. For comparisons of consecutive 
measurements,theWilcoxonSignedRankstestwillbeusedforpairsofmeasurements,theFriedman 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 24 patients for each group (the group undergoing ESPB and the group not undergoing 
ESPB) to ensure a 95% confidence level with an alpha=0.05 error and a 0.99 effect size, for a total of 
48 patients. 
 
 
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