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

NCT06136000 | Completed

• 1 other identifier: STUDY SACRAL ERECTÖR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pain; Pain, Postoperative

Keywords

erectör spinae plane block; ring block; postoperative analgesia

Outcome Measures

Primary Outcomes (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).

  FİVE MONTHS

Secondary Outcomes (1)

• Postoperative rescue analgesia

  FİVE MONTHS

Study Arms (2)

SACRAL EREKTÖR SPİNAE PLANE BLOK

ACTIVE COMPARATOR

Other: Sacral erectör spinae plane block

RİNG BLOCK

ACTIVE COMPARATOR

Other: Ring Block

Interventions

Sacral erectör spinae plane block OTHER

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.

SACRAL EREKTÖR SPİNAE PLANE BLOK

Ring Block OTHER

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.

RİNG BLOCK

Eligibility Criteria

• Age: 4 Years - 16 Years
• Gender Eligibility Details: BOYS WHO WILL BE CIRCUMCISED
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, 38000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist, Department of Anesthesiology, Konya City Hospital, M.D

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 18, 2023
• Study Start: December 19, 2023
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)