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Comparison of Erector Spinae Plane Block and Penile Block in Hypospadias Surgery

K

Kocaeli University

Status

Unknown

Conditions

Postoperative Pain
Analgesia

Treatments

Procedure: The dorsal penile block
Procedure: The ultrasound-guided Sacral Erector spinae plane block

Study type

Interventional

Funder types

Other

Identifiers

NCT04866368
KSU 2019/12-17

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

1 to 9 years old

Volunteers

No Healthy Volunteers

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

  • American Society of Anesthesiology Classification (ASA) III-IV, patients with coagulopathy patients with infection at the injection site

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

The erector spinae plane block
Active Comparator group
Description:
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.
Treatment:
Procedure: The ultrasound-guided Sacral Erector spinae plane block
The penile block
Active Comparator group
Description:
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.
Treatment:
Procedure: The dorsal penile block

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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