Sacral Erector Spinae,Penile and Caudal Block for Pain Relief After Hypospadias Surgery

NCT05307653 | Completed

• 1 other identifier: Pain Relief After Hypospadius
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Caudal anaesthesia is recommended for most surgical procedures of the lower part of the body, mainly below the umbilicus, including inguinal hernia repair, urinary and digestive tract surgery and orthopaedic procedures on the pelvic girdle and lower extremities. It has been well established that a dorsal penile nerve block immediately after surgery decreases postoperative pain in children undergoing hypospadias repair. For decades, penile block was widely and effectively used for various types of penile reconstructive surgery. Recently, due to improved composition, dosage and concentration of local anaesthetics and low incidence of negative side effects, such as motor blockade and postoperative nausea and vomiting, caudal anaesthesia has become one of the most used and accepted regional blocks for children undergoing hypospadias repair. However, postoperative patient comfort is a major issue after distal hypospadias repair and depends on adequate analgesia and unimpaired micturition, especially when no suprapubic catheter is in place. Micturition impairment and urinary retention is a known side effect of caudal block anaesthesia. The comparison of penile block and caudal block has not been described in the literature to our knowledge. Use of ESPB for different indications from different levels has become the new trend of regional anesthesia practice from the moment it was first defined . There have been many reports for its use in thoracic and lumbar levels. This great interest probably depends on its effectiveness as well as the ease of the block technique: injecting the local anesthetic deep to the erector spinae muscle (ESM) above the transverse process. With this report, we would like to identify a modification to sacral ESPB with our longitudinal midline approach with the presentation of a case of an infant who was scheduled for hypospadias repair.

Conditions

Sacral Erector Spinae, Penile And Caudal Block For Pain Relief After Hypospadius Surgery

Outcome Measures

Primary Outcomes (1)

• Time to the first analgesic request

  The time (in hours) from the beginning of the block to the first rescue analgesia request was recorded

  24 hours postoperative

Secondary Outcomes (4)

• Face, Legs, Activity, Cry, and Consolability (FLACC) Score

  24 hours Postoperative

• The total amount of analgesia

  24 hours Postoperative

• The incidence of perioperative complications.

  24 hour postoperatively

• Penile engorgement

  Intraoperatively

Study Arms (3)

Penile block

EXPERIMENTAL

Penile block was performed in supine position. The penis was retracted caudally and then fixed with a leucoplast. After identifying the symphysis pubis (SP), a 22-gauge needle was inserted vertically about 1 cm lateral to the SP, and bupivacaine 0.5% (0.1 ml/kg, maximum 2.5 ml) was injected on each side after penetrating the Scarpa's fascia.

Procedure: Penile block

Erector spinea plain block group

EXPERIMENTAL

Ultrasound guided ESPB was performed in prone position by Philips © (CX50 Extreme edition). The superficial probe was placed longitudinally at the midline just above the sacrum, and both erector spinae muscles and median sacral crests were identified. Using the in-plane approach, a 22-gauge needle was inserted in a craniocaudal direction till reaching the tip of the fourth median sacral crest. After negative aspiration to avoid intravascular or intrathecal puncture, bupivacaine 0.25% (1 ml/kg, maximum 20 ml) was administered.

Procedure: Erector spinea plain block

Caudal group

EXPERIMENTAL

Caudal block was performed in the left lateral position. A 22 G needle was inserted through the sacral hiatus. The loss of resistance method was used to pass through the sacrococcygeal membrane and enter the caudal epidural space. Negative aspiration was then performed. When no blood or cerebrospinal fluid was observed, bupivacaine 0.25% (1 ml/kg, maximum 20 ml) was administered. The patient was returned to the supine position after the procedure was completed.

Procedure: Caudal block

Interventions

Penile block PROCEDURE

Penile block was performed in supine position. The penis was retracted caudally and then fixed with a leucoplast. After identifying the symphysis pubis (SP), a 22-gauge needle was inserted vertically about 1 cm lateral to the SP, and bupivacaine 0.5% (0.1 ml/kg, maximum 2.5 ml) was injected on each side after penetrating the Scarpa's fascia.

Penile block

Erector spinea plain block PROCEDURE

Ultrasound guided ESPB was performed in prone position by Philips © (CX50 Extreme edition). The superficial probe was placed longitudinally at the midline just above the sacrum, and both erector spinae muscles and median sacral crests were identified. Using the in-plane approach, a 22-gauge needle was inserted in a craniocaudal direction till reaching the tip of the fourth median sacral crest. After negative aspiration to avoid intravascular or intrathecal puncture, bupivacaine 0.25% (1 ml/kg, maximum 20 ml) was administered.

Erector spinea plain block group

Caudal block PROCEDURE

Caudal block was performed in the left lateral position. A 22 G needle was inserted through the sacral hiatus. The loss of resistance method was used to pass through the sacrococcygeal membrane and enter the caudal epidural space. Negative aspiration was then performed. When no blood or cerebrospinal fluid was observed, bupivacaine 0.25% (1 ml/kg, maximum 20 ml) was administered. The patient was returned to the supine position after the procedure was completed.

Caudal group

Eligibility Criteria

• Age: 1 Year - 5 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Bleeding diathesis
• Known allergy to local anesthesia medications
• Active infection at the injection area
• History of developmental delay
• Mental retardation (due to difficult pain assessment).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, ELgharbiaa, 31527, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: April 15, 2022
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-08

Locations

EG (1)