Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06136000 |
| Other study ID # |
STUDY SACRAL ERECTÖR |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 19, 2023 |
| Est. completion date |
April 15, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Konya City Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Although it is not known exactly when and where circumcision was first performed, it is
claimed that it was first performed by the Egyptians, according to various beliefs and
traditions. Circumcision is the surgical removal of the skin surrounding the glans penis in
pediatric male patients and is the most commonly performed surgery in boys (4). Because the
foreskin is sensitive and the pain threshold is low, patients experience severe pain in the
postoperative period. Various analgesic methods have been developed to reduce this pain.
Sacral surgery has started to be used in adult patients in recent years, but there is not
enough information about its application in pediatric patients. Sacral erector spinae plane
block is on the agenda. While sacral erectör spinae plane block was first applied in gender
reassignment and pilonidal sinus surgery in adults, it was also applied to a small extent in
hypospadias and anoplasty surgery in pediatric patients. In some studies, circumcision
surgery involves the root and distal parts of the penis. It has been emphasized that ring
blocks applied with anesthesia also have an analgesic effect. Our aim in this study was to
compare the effect of S-ESPB and ring block on postoperative Face, Legs, Movement, Crying,
Avocative Behavioral Scale pain scores in pediatric patients undergoing circumcision surgery
and to compare the number of patients who required rescue analgesia, the time until the first
rescue analgesia, possible complications, and parental satisfaction (a Likert scale will be
used).
In this study, we found that sacral erectör spinae plane block is different from the ring
block applied in routine practice in circumcision surgery. We think that postoperative
analgesic effectiveness will be higher.
Our aim in this study was to compare the effect of sacral erectör spinae plane block and ring
block on postoperative Face, Legs, Movement, Crying, Avocative Behavioral Scale pain score in
pediatric patients undergoing circumcision surgery and to compare the number of patients who
required rescue analgesia secondarily, the time until the first rescue analgesia, possible
complications and parental satisfaction (Likert scale will be used).
Description:
Our primary hypothesis erectör spinae plane block will be effective in pediatric patients
undergoing circumcision surgery. The effect on postoperative pain will be greater than the
applied ring block and the Face, Legs, Movement, Crying, Avocative Behavioral Scale pain
score will be lower.
Our secondary hypothesis is that the number of patients requiring rescue analgesia and the
complications that may occur will be lower in sacral erectör spinae plane block to be applied
in circumcision surgery compared to the ring block, and parental satisfaction and the time
until the first rescue analgesia will be higher.
Material oath methods: Our study will be carried out within 6 months with 50 patients in the
operating room of Konya City Hospital of the University of Health Sciences and the operating
room of Harran University Faculty of Medicine Randomization This study was a multicenter
prospective study. It was planned and will be carried out as a randomized study.
Randomization will be carried out by the sealed envelope method. Patients will be divided
into two groups: Group R (patients who underwent Ring block) and Group S (patients who
underwent sacral erectör spinae plane block). Since it is a multicenter study, the anesthesia
technique will be applied by two different physicians with at least five years of clinical
experience and the postoperative results will be recorded by 2 different physicians. These
physicians will evaluate patients completely independently and blindly. Written and verbal
consent will be obtained from the patient's parents.
Anesthesia Technique and Analgesia Protocol:
Routine anesthesia monitoring and method will be applied to all patients. 22 gauge to
patients Intravenous ( IV ) cannulation is provided and 15cc/kg/ h Isotonic fluid will be
started. General anesthesia induction 1mg midazolam IV, 2 mg/kg propofol IV, and 1 mcg /kg
remifentanil It will be done by giving IV. The patients will be fitted with a laryngeal mask
airway (LMA), which we use in routine practice, and will require minimum anesthesia
maintenance. alveolar Sevoflurane will be given with a concentration (MAC) value of 1. Before
the surgical procedure begins, sacral erectör spinae plane block will be applied to the
patients by the anesthesiologist or ring block by the pediatric surgeon. Then circumcision
surgery will begin. The same surgical method will be applied to all patients.
At the end of the surgery, we routinely administer 15 mg/kg IV to all patients. Paracetamol
will be given. Extubated patients will be transferred to the postanesthetic care unit (PACU)
for observation. 0-1-2-4-6 from the time patients are admitted to the PACU until they are
discharged from the hospital. Pain levels will be evaluated with the Face, Legs, Movement,
Crying, Avocative Behavioral Scale pain scale. Patients with a Face, Legs, Movement, Crying,
Avocative Behavioral Scale score of 4 and above will be given 10 mg/kg oral ibuprofen rescue
analgesia. The number of patients requiring rescue analgesia, the time until the first rescue
analgesia, complications that will develop, and parental satisfaction will be recorded.
sacral erectör spinae plane block with ultrasound guidance Group S will be placed on their
side. Asepsis is fifth in the transverse plane under antisepsis standards. high-frequency
[(10-15 millihertz ( mHz )] linear ultrasonography probe into the spinous process The
ultrasonography probe will be shifted caudally to visualize the first and second median
sacral crest. The USG probe is then placed on the second medial It will be placed 3-4 cm
lateral to the sacral apex and the mid-sacral apex will be imaged. On the ultrasonography
screen, from top to bottom, erector spinae muscle, multifidus muscle and sacral intermediate
The crest will be displayed. 0.25% bupivacaine will be administered in a total volume of
0.5ml/kg (maximum 20 cc ) by applying negative aspiration with the in-plane technique with a
50 mm Stimuplex A needle. The process will be applied bilaterally.
Ring Block It is a block that is routinely performed in our clinic by a pediatric surgeon.
The patient is under general anesthesia. Before the surgical procedure begins, the pediatric
surgeon administers 0.5ml/kg (maximum 20cc) 0.25% bupivacaine to the base of the root of the
penis with a 25-gauge needle at 3, 6, 9, and 12 o'clock. local It will be administered under
anesthesia.
Primary evaluation criteria are the Face, Legs, Movement, Crying, Avocative Behavioral Scale
of pain at rest and movement at 0, 1, 2, 4, and 6 hours after surgery (0-10, 0 = no pain, 1-3
= mild pain, 4-6 = moderate pain, 7- It will be evaluated with 10 = the most severe pain).
Secondary evaluation criteria are the number of patients needing rescue analgesia, the time
until the first rescue analgesia, the complications that will develop, and parental
satisfaction. The age, weight, height, and surgery duration of the patients in both groups
were recorded. Likert evaluation test will be applied for parental satisfaction.
Sample Size:
for circumcision under general anesthesia. patients who will undergo surgery. In the sample
size analysis, it was determined that there should be 19 patients for each group with a 95%
power rate and an alpha margin of error of 0.05 for comparison of the two groups. The effect
used for this calculation is 1.106, based on similar studies, actual power was calculated as
0.955. As a result of the analysis, drop Considering the out rate, it was planned to recruit
25 patients for each group (50 patients in total).
Statistical Analyzes To determine whether the data is normally distributed, the Shapiro Wilks
test will be used. Descriptive statistical analyses will be used to evaluate demographic data
and data obtained from tests and scales. A paired sample T-test will be used to compare data.
Correlation analysis will be used to evaluate the relationship between data. Data will be
expressed as mean ± standard deviation and percentage. P <0.05 will be considered
statistically significant. In correlation analysis, confidence intervals and p-values will be
evaluated according to whether they show a statistically significant or non-significant
inverse interaction.
