Analgesia in Pediatric Hypospadias Surgeries

NCT ID: NCT06410482

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2025-06-30

Brief Summary

The primary aim of the current study will be to use the duration until the first postoperative analgesic requirement after two different block techniques to compare the analgesic effect.

The secondary aims will be to compare the two methods for postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scores, complications and parental satisfaction scores.

Detailed Description

Hypospadias, seen in every 200-300 births, is one of the most common congenital anomalies of the penis and is defined as the urethral meatus being located in the ventral part of the penis instead of its normal place.

Although current guidelines propose an optimal age for hypospadias repair of 6-18 months , patient ages vary widely, from infants to adults, in daily practice. According to the literature, hypospadias surgery can be performed in a wide age range of 6 months-12 years. The age of the patients undergoing hypospadias surgery in our country can vary between 1 and 10 years. The surgery of this anomaly is very painful in the postoperative period and requires long-term analgesia. Regional anesthesia methods combined with general anesthesia play an important role in providing effective and long-term postoperative pain control in pediatric penile surgery. These methods also reduce postoperative morbidity, enable early mobilization and significantly decrease the need for narcotic analgesics.

A dorsal penile nerve block (DPNB) and caudal epidural block (CEB) are commonly used regional anesthesia techniques for postoperative pain control in hypospadias repair. CEB is the more commonly used neuraxial block method for providing effective postoperative analgesia in lower abdominal, urogenital and lower extremity surgical operations in pediatric patients. However, it has recently been suggested in the literature that peripheral nerve blocks should be preferred to neuraxial blocks as they provide longer-term analgesia and have fewer side effects. DPNB is a peripheral nerve block method that has been widely used for various penile operations since it will be first defined in the mid-1970s. This method is mostly used with the landmark technique. It will be first used by Sandeman et al via the out-of-plane technique with ultrasound (US) and will be reported to provide effective analgesia in the postoperative period. Suleman et al described DPNB for the first time with the in-plane technique, indicating that the tissue and neurovascular structures of the penis could be better distinguished in the transverse plane in ultrasound (US). A limited number of studies have shown the technique to provide more effective and longer term postoperative analgesia compared to the landmark technique and CEB.

Conditions

Hypospadias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

US guided caudal block Anesthesia

Children will receive caudal block analgesia

Group Type: EXPERIMENTAL

US guided caudal block

Intervention Type: PROCEDURE

After placing the patient in the left lateral position (hips and knees flexed) following monitoring and induction of anaesthesia, the field will be sterilized with 70% alcohol in 2% chlorhexidine.

Initial scanning in the transverse plane allows for visualization of the midline and identification of the sacrococcygeal ligament between the 2 sacral cornua. The 2 cornua resemble the 2 eyes of a frog and thus are collectively called the frog-eye sign. The US probe is then rotated 90 degrees to acquire a longitudinal view. The needle is then advanced at a 20-degree angle with needle tip and length visualization Once the needle is confirmed to be in the caudal space on the screen, carefully aspirate to confirm absence of CSF or blood.

A slow injection of the local anaesthetic can then be performed, dose of (0.2 mL/kg 0.25% bupivacaine and 1 μg/kg of dexmedetomidine

Dorsal penile nerve block Anesthesia

Children will receive Penile block analgesia

Group Type: ACTIVE_COMPARATOR

Dorsal penile nerve block

Intervention Type: PROCEDURE

after general anesthesia induction. With the patient in the supine position. After skin sterilization the US linear probe will be transversely placed on the root of the penis. After placing the penis in gentle traction, a50 mm block needle will be inserted from the lateral part of the penis root towards the dorsal section of the penis with the in-plane technique, It will be advanced through Dartos fascia until resistance to the needle disappeared.

Once the superficial sheath will be passed, the tip of the needle will be advanced into Buck's fascia and then positioned between Buck's fascia and tunica albuginea, lateral to the dorsal artery. After making sure there will be no blood with negative aspiration, half of the total 0.2 mL/kg dose of 0.25% bupivacaine will be administered while observing its distribution with US. The same procedure will be then repeated on the other side of the penis.

Interventions

US guided caudal block

After placing the patient in the left lateral position (hips and knees flexed) following monitoring and induction of anaesthesia, the field will be sterilized with 70% alcohol in 2% chlorhexidine.

Initial scanning in the transverse plane allows for visualization of the midline and identification of the sacrococcygeal ligament between the 2 sacral cornua. The 2 cornua resemble the 2 eyes of a frog and thus are collectively called the frog-eye sign. The US probe is then rotated 90 degrees to acquire a longitudinal view. The needle is then advanced at a 20-degree angle with needle tip and length visualization Once the needle is confirmed to be in the caudal space on the screen, carefully aspirate to confirm absence of CSF or blood.

A slow injection of the local anaesthetic can then be performed, dose of (0.2 mL/kg 0.25% bupivacaine and 1 μg/kg of dexmedetomidine

Intervention Type: PROCEDURE

Dorsal penile nerve block

after general anesthesia induction. With the patient in the supine position. After skin sterilization the US linear probe will be transversely placed on the root of the penis. After placing the penis in gentle traction, a50 mm block needle will be inserted from the lateral part of the penis root towards the dorsal section of the penis with the in-plane technique, It will be advanced through Dartos fascia until resistance to the needle disappeared.

Once the superficial sheath will be passed, the tip of the needle will be advanced into Buck's fascia and then positioned between Buck's fascia and tunica albuginea, lateral to the dorsal artery. After making sure there will be no blood with negative aspiration, half of the total 0.2 mL/kg dose of 0.25% bupivacaine will be administered while observing its distribution with US. The same procedure will be then repeated on the other side of the penis.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• • Children aged 1-7 years old

• ASA I and II
• Children scheduled for primary hypospadias repair

Exclusion Criteria

• • Patient's guardian refusal to participate in the study.

• Children with Behavioural changes; physical or developmental delay; neurological disorder or psychological disorder.
• Children on sedative or anticonvulsant medication.
• Bleeding diathesis
• Infection of injecting area
• significant organ dysfunction, cardiac, liver or mental retardation.
• Congenital low back anomaly.
• Known allergy to the study drugs

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 7 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Esraa Gaafer

Resident Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Esraa Gaafer, Resident

Role: CONTACT

esraa.gaafer10@gmail.com

+201156063201

khaled Tolba, Lecturer

Role: CONTACT

khaledtolba@med.aun.edu.eg

+201022653633

References

Kendigelen P, Tutuncu AC, Emre S, Altindas F, Kaya G. Pudendal Versus Caudal Block in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):610-5. doi: 10.1097/AAP.0000000000000447.

Reference Type: BACKGROUND

PMID: 27501015 (View on PubMed)

Yigit D, Ozen V, Kandirici A, Dokucu AI. Ultrasound-guided dorsal penile nerve block is a safe block in hypospadias surgery: A retrospective clinical study. Medicine (Baltimore). 2022 Jul 1;101(26):e29700. doi: 10.1097/MD.0000000000029700.

Reference Type: BACKGROUND

PMID: 35777019 (View on PubMed)

Other Identifiers

pediatric hypospadias

Identifier Type: -

Identifier Source: org_study_id