Comparison of Transversus Abdominis Plane (TAP) block, Ilioinguinal Nerve Block and Surgical Infiltration for Orchidoplexy and Hydrocele Repair in Children.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005441-34-IE

Enrollment

Registered

2008-09-03

Start date

2009-06-04

Completion date

Unknown

Last updated

2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comparison of Transversus Abdominis Plane (TAP) block, Ilioinguinal Nerve Block and Surgical Infiltration for Orchidoplexy and Hydrocele Repair in Children. MedDRA version: 9.1 Level: LLT Classification code 10054711 Term: Postoperative pain

Interventions

Trade Name: Chirocaine Product Name: Levobupivacaine Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Children aged 6 months to 6 years Presenting for elective or emergent urology surgery Written Informed Parental/Guardian consent ASA Grade 1 to 3 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Parental/Guardian refusal Outside Age Range Allergy to Levobupivacaine, Morphine, Paracetamol, Sodium Diclofenac Skin lesions/infection at site of injection Renal or other organ dysfunction Sepsis Epilepsy/Seizure disorder

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to compare the analgesic efficacy of the Transversus Abdominis Plane block, (TAP) with ilioinguinal/iliohyogastric block and wound infiltration for this surgical incision. Does the administration of levobupivacaine, into the transversus abdominis neurofascial plane (i.e. a Transversus Abdominis Plane Block, TAP Block) provide superior pain relief and reduced rescue analgesia, i.e. morphine, in children undergoing the suprapubic incision for urology surgery. Primary Measures: Severity of Postoperative Pain via CHEOPS score Total opiate usage in the first 24 hours after surgery ;Secondary Objective: To determine the potential for the TAP Block to reduce postoperative side effects of morphine such as nausea and vomiting, and sedation in children undergoing urological surgery with a suprapubic incision. Secondary Measures: Sedation Postoperative Nausea and Vomiting Patient (and Parent) Satisfaction ;Primary end point(s): Severity of Postoperative Pain via CHEOPS score Total opiate usage in the first 24 hours after surgery	—

Measure

Time frame

Main Objective: The aim of the study is to compare the analgesic efficacy of the Transversus Abdominis Plane block, (TAP) with ilioinguinal/iliohyogastric block and wound infiltration for this surgical incision. Does the administration of levobupivacaine, into the transversus abdominis neurofascial plane (i.e. a Transversus Abdominis Plane Block, TAP Block) provide superior pain relief and reduced rescue analgesia, i.e. morphine, in children undergoing the suprapubic incision for urology surgery. Primary Measures: Severity of Postoperative Pain via CHEOPS score Total opiate usage in the first 24 hours after surgery ;Secondary Objective: To determine the potential for the TAP Block to reduce postoperative side effects of morphine such as nausea and vomiting, and sedation in children undergoing urological surgery with a suprapubic incision. Secondary Measures: Sedation Postoperative Nausea and Vomiting Patient (and Parent) Satisfaction ;Primary end point(s): Severity of Postoperative Pain via CHEOPS score Total opiate usage in the first 24 hours after surgery

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Countries

Ireland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026