Comparison of Sacral Erector Spinae Plane Block and Dorsal Penile Block in Pain Management in Patients Undergoing Hypospadias Surgery
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Kocaeli University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- FLACC score
Study Overview
Brief Summary
In this study, we aimed to compare ultrasound-guided sacral erector spinae plane block and dorsal penile block on postoperative analgesic effect in hypospadias surgery.
Detailed Description
ASAI-II, 1-9 years old patients with hypospadias diagnosis and operated in Kahramanmaraş Sütçü İmam University hospital and Kocaeli University hospital were randomized with closed envelope technique and divided into two groups as penile block or erector spinae plane block. Erector spinae plane block or penile block application (by Gözen Öksüz, Can Aksu) will be performed after the patients give standard general anesthesia and a laryngeal mask is applied. Vital signs such as pulse, sp02, blood pressure will be monitored before, during and at the end of the operation. At the end of the operation and after the patient is awakened 5. min., 30 min. 1., 2., 4., 6., 12., 24. hourly FLACC pain scores, number of analgesic use within 24 hours, patient family satisfaction (1: dissatisfied, 2: satisfied, 3: very satisfied), complication rates will be recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •American Society of Anesthesiology Classification (ASA) I-II, 1-9 years aged patients patients who scheuled elective hypospadias surgery in Kahramanmaraş Sütçü İmam University Hospital and Kocaeli University Hospital
Exclusion Criteria
- •xclusion Criteria:
- •American Society of Anesthesiology Classification (ASA) III-IV, patients with coagulopathy patients with infection at the injection site
Arms & Interventions
The erector spinae plane block
The ultrasound-guided Erector spinae plane block (ESPB) with 1 ml/kg 0,25 % bupivacaine at the lumbar vertebral level will perform before surgery to all patients in the ESPB group.
Intervention: The ultrasound-guided Sacral Erector spinae plane block (Procedure)
The penile block
The penile block with 0,5ml/kg 0,25 % bupivacaine will be performed after the patients give standard general anesthesia and a laryngeal mask is applied.
Intervention: The dorsal penile block (Procedure)
Outcomes
Primary Outcomes
FLACC score
Time Frame: during postoperative 24 hour
At the end of the operation and after the patient is awakened 5th min., 30th min., 1st, 2nd, 4th, 6th, 12th, 24th Hourly FLACC pain scores will be recorded.
Secondary Outcomes
No secondary outcomes reported
Investigators
Can AKSU
Associate professor
Kocaeli University