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PainNCT06136000

S-ESP and Ring Block in Circümcision Surgery (S-ESP: Sacral Erectör Spinae Plane Block).

A study testing Sacral erectör spinae plane block and Ring Block in people with Pain and Pain, Postoperative, run by Konya City Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 4 to 16 years, men only
Conditions the study is for
Pain, Pain, Postoperative
What is being tested?
Sacral erectör spinae plane block and Ring Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
19 Dec 2023to 15 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 16 years
  • Men only
  • No healthy volunteers
  • Child

Who may be able to join

  • patients between the ages of 4-16
  • patients with ASA I-II.
  • Patients who will receive general anesthesia

Who cannot join

  • Parents and patients who do not want to give consent
  • Patients with ASAIII and above
  • Patients with a disordered bleeding profile
  • Patients using anticoagulants
  • Patients with infection in the area to be treated

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Konya City Hospital

    Konya, 38000

Other trials in Turkey (Türkiye)

About this study

Official title: Sacral Circumcision Surgery: Comparison of the Effects of Erector Spina Plane Block and Ring Block on Postoperative Pain

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).

Read the detailed 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.

Being tested
Sacral erectör spinae plane block, Ring Block
Keywords
erectör spinae plane block, ring block, postoperative analgesia
Medical subject headings
Pain, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacral erectör spinae plane blockOther

    Group S will be placed on their side. Asepsis is fifth in the transverse plane under antisepsis standards. high-frequency linear USG probe into the spinous process . The USG 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 USG 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.

  • Ring BlockOther

    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.

Study groups in NCT06136000
Study groupRoleWhat they receive
SACRAL EREKTÖR SPİNAE PLANE BLOKActive comparatorNot described
Receives: Other: Sacral erectör spinae plane block
RİNG BLOCKActive comparatorNot described
Receives: Other: Ring Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Face, Legs, Movement, Crying, Avocative Behavioral Scale

    Primary evaluation criteria are the Face, Legs, Movement, Crying, Avocative Behavioral Scaleof 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).

    Measured: FİVE MONTHS

Secondary outcomes (1)
  1. Postoperative rescue analgesia

    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 (kilogram), height (centimeter) and surgery duration of the patients in both groups were recorded. Likert evaluation test will be applied for parental satisfaction.

    Measured: FİVE MONTHS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start19 Dec 2023
  3. Primary completion15 Apr 2024
  4. Study completion15 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06136000
Sponsor's protocol ID
STUDY SACRAL ERECTÖR
Status last verified
Apr 2024
First submitted
8 Nov 2023
Last updated
16 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sacral erectör spinae plane block and Ring Block in people with Pain and Pain, Postoperative, run by Konya City Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Face, Legs, Movement, Crying, Avocative Behavioral Scale (time frame: FİVE MONTHS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.

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Clinical Trial NCT06136000 | AzTrials