Comparison of the Effects of Sacral Erector Spinae Plane Block and Dorsal Penile Block on Postoperative Pain in Circumcision Procedures
Comparison of the Effects of Sacral Erector Spinae Plane Block and Dorsal Penile Block on Postoperative Pain in Circumcision Operations
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Although it is not known exactly where it was first performed, there is evidence that the Egyptians performed circumcision in 2300 BC. While circumcision is performed for health reasons in some societies, it is a traditional, religious and cultural practice in some. In our clinic, circumcision cases are performed with anesthesia monitoring and premedication with midazolam (0.1 mg/kg) followed by penile block, which is our clinical practice, by experienced pediatric surgeons who perform the surgical procedure without the use of ultrasound. In addition to penile block in standard practice, general anesthesia is applied to patients with sevoflurane, ketamine, fentanyl and propofol, depending on the patient's age and weight, depending on the need for intraoperative anesthesia and analgesia. Postoperative pain after surgeries on the penis is a problem that directly affects postoperative recovery in young patients because the surgical procedure itself is often minor (treatment of phimosis, circumcision), whereas the pain produced is both severe and long-lasting.
The need for analgesia is a topic that always occupies anesthesia practice and maintains its relevance. It is vital to ensure early mobilization and discharge of patients. Many side effects, including somnolence, vomiting and respiratory depression, call into question the use of opioids in pediatrics.
Today, the use of ultrasound-guided nerve block has resulted in a revolutionary change in the field of regional anesthesia in pediatrics. Many truncal blocks are used with a high success rate in both upper and lower abdominal surgeries and have become standard in terms of patient safety.
Sacral ESP block, especially applied in children, has become an increasingly important technique due to its advantages such as applicability, ease of anatomical approach, distance to the medulla spinalis and surgical site, and low risk of infection. In addition, studies have shown that it is quite effective in postoperative pain.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Meram
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Konya, Meram, Turkey (Türkiye), 42140
- Yasin Tire
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
**Inclusion Criteria:**
- Age 7 to 12 years.
- American Society of Anesthesiologists (ASA) Physical Status I or II.
- Scheduled to undergo elective circumcision under general anesthesia.
- Ability to communicate pain using the study pain assessment tools.
- Written informed consent obtained from a parent or legal guardian.
**Exclusion Criteria:**
- Refusal or inability of the parent/legal guardian or participant (when appropriate) to provide informed consent or assent.
- American Society of Anesthesiologists (ASA) Physical Status III or higher.
- Emergency surgery.
- History of significant hematologic, cardiovascular, hepatic, or renal disease.
- Current anticoagulant therapy.
- Known hypersensitivity or allergy to local anesthetic agents.
- Previous penile surgery.
- Any condition that, in the investigator's judgment, would interfere with study participation or outcome assessment.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group P (Penile Block)
Patients who underwent Dorsal Penile Block after circumcision surgery
|
P arm: Patients who underwent Dorsal Penile Block after circumcision surgery
|
|
Group S (Sacral ESP Block)
Patients who underwent Sacral Erector Spinae Plane Block after circumcision surgery
|
S arm: Patients who underwent Sacral Erector Spinae Plane Block after circumcision surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PRIMARY OUTCOME
Time Frame: From admission to the post-anesthesia care unit through postoperative hour 6.
|
Postoperative pain intensity will be assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) Scale.
The FLACC Scale ranges from 0 to 10, with higher scores indicating greater pain intensity and therefore a worse outcome.
Pain assessments will be performed upon admission to the post-anesthesia care unit and at 30-minute intervals during the post-anesthesia care unit stay, followed by assessments at postoperative hours 1, 2, 4, and 6 or until hospital discharge, whichever occurs first.
|
From admission to the post-anesthesia care unit through postoperative hour 6.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SECONDARY OUTCOME
Time Frame: Postoperative hour 6.
|
Parents will assess their child's postoperative pain before hospital discharge using a 4-point Simple Pain Scale.
Scores range from 0 to 3, where 0 indicates no pain or a calm child, 1 indicates minimal pain or an irritable child, 2 indicates mild pain or a consolable child, and 3 indicates severe pain or an inconsolable child.
Higher scores indicate greater pain intensity and therefore a worse outcome.
|
Postoperative hour 6.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Study Pedsac
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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