Incidence of Urethrocutaneous Fistula With and Without Caudal Epidural Block
Kata kunci
Abstrak
Deskripsi
CEB is routinely used along with general anaesthesia for inguinal and genital surgeries. It provides intraoperative and postoperative analgesia, is safe, simple and has success rate of more than 90% in children.It decreases the requirement of inhalational anaesthetics and narcotics, decreases stress hormone release and facilitates early recovery. Hypospadias is the most common congenital anomaly of penis, incidence being 1 in 300 live births. Hypospadias repair is a technical procedure that can be associated with significant complications such as meatal stenosis, stricture, glans dehiscence and flap necrosis Urethrocutaneous fisula formation is the most common complication after primary repair with an incidence of upto 20%. There have been controversies regarding the association of CEB with urethrocutaneous fistula. Some studies have reported a high incidence of postoperative urethrocutaneous fistula in children who received CEB while others have not confirmed any such relationship. Association between urethrocutaneous fistula and site of urethral opening, age of patient, duration of surgery, surgeon's expertise, use of subcutaneous epinephrine and use of preoperative testosterone has been found. Penile engorgement, post inflammatory response and tissue oedema may be contributory factors for development of fistula. However any association between CEB and fistula formation is not clear. All studies, except one, are retrospective, limited by small sample size and presence of various confounding factors. The present study is aimed to explore any association between CEB and urethrocutaneous fistula. The study will be conducted in children with distal hypospadias only; they will be operated by a single surgeon, without the use of subcutaneous epinephrine, so that any association, if at all between CEB and urethrocutaneous fistula becomes evident.
tanggal
| Terakhir Diverifikasi: | 03/31/2019 |
| Pertama Dikirim: | 01/18/2019 |
| Perkiraan Pendaftaran Telah Dikirim: | 01/18/2019 |
| Pertama Diposting: | 01/22/2019 |
| Pembaruan Terakhir Dikirim: | 04/03/2019 |
| Pembaruan Terakhir Diposting: | 04/04/2019 |
| Tanggal Mulai Studi Sebenarnya: | 02/21/2019 |
| Perkiraan Tanggal Penyelesaian Utama: | 11/30/2019 |
| Perkiraan Tanggal Penyelesaian Studi: | 12/31/2019 |
Kondisi atau penyakit
Intervensi / pengobatan
Drug: Caudal Group
Drug: Non- Caudal Group
Tahap
Kelompok Lengan
| Lengan | Intervensi / pengobatan |
|---|---|
| Active Comparator: Caudal Group Children will receive oral midazolam 0.25 mg/kg thirty minutes before induction. Inhalational induction will be carried with incremental concentration of sevoflurane upto 8% in 50% oxygen and nitrous oxide mixture. As soon as the child will be asleep, ASA standard monitors (SPO2, HR, ECG and NIBP) will be attached. Intravenous access with age appropriate IV cannula will be secured. Injection fentanyl citrate 2 mcg/ kg followed by injection atracurium 0.5 mg/kg will be administered. Appropriate size LMA Pro SealTM will be inserted and pressure controlled ventilation will be instituted.
Children in will then receive CEB with 0.2 % ropivacaine 1-ml/kg for maintaining analgesia | Drug: Caudal Group Intraoperatively after induction of anaesthesia caudal epidural block will be administered with 0.2% ropivacaine 1-ml/kg |
| Active Comparator: Non- Caudal Group Children will receive oral midazolam 0.25 mg/kg thirty minutes before induction. Inhalational induction will be carried with incremental concentration of sevoflurane upto 8% in 50% oxygen and nitrous oxide mixture. As soon as the child will be asleep, ASA standard monitors (SPO2, HR, ECG and NIBP) will be attached. Intravenous access with age appropriate IV cannula will be secured. Injection fentanyl citrate 2-mcg/ kg followed by injection atracurium 0.5 mg/kg will be administered. Appropriate size LMA Pro SealTM will be inserted and pressure controlled ventilation will be instituted.
Children in will then receive fentanyl citrate 1-mcg/kg/hr for maintaining analgesia | Drug: Non- Caudal Group Intraoperatively after induction of anaesthesia fentanyl 1-mcg/kg/hour will be administered |
Kriteria kelayakan
| Usia yang Layak untuk Belajar | 1 Year Untuk 1 Year |
| Jenis Kelamin yang Layak untuk Belajar | Male |
| Menerima Relawan Sehat | Iya |
| Kriteria | Inclusion Criteria: 1. Male children l 2. 1 to 8 years of age 3. ASA physical status I and II 4. Distal hypospadias - Exclusion Criteria: 1. Simultaneously undergoing any other procedure 2. Local infection in sacral region 3. Bleeding diathesis 4. Preoperative testosterone stimulation |
Hasil
Ukuran Hasil Utama
1. Incidence of urethrocutaneous fistula [From one day after surgery(0-hours, baseline) till 3-months post surgery]
Ukuran Hasil Sekunder
1. Penile Engorgement [After induction of anaesthesia (0-hours, baseline) till end of surgery]
2. Changes in intra-operative heart rate (beats per minute) [From beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively]
3. Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg) [rom beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively]
4. Postoperative analgesia requirement [From end of anaesthesia (0-hours, baseline) till 24-hours postoperatively]
5. Incidence of complications [From end of anaesthesia (0-hours, baseline) till 3-months postoperatively]
