Ratifying dosage and duration for levo-bupivacaine, a local anaesthetic infusion by the caudal-epidural route in infants 3-6 months.

Phase 1

• Conditions: Pain relief in infants undergoing surgical repair of bladder exstrophy; MedDRA version: 18.0 Level: PT Classification code 10054799 Term: Perioperative analgesia System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.0 Level: PT Classification code 10036276 Term: Postoperative analgesia System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-000393-34-GB
• Lead Sponsor: Central Manchester University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

All infants aged between 3–6 months postnatal age, undergoing Bladder Exstrophy repair will be considered. But only those infants whose parents consent to a caudal-epidural block, as well as to this study will be included.
This is a rare condition and we see 5-7 patients/year. Taking into account the exclusion criteria we expect to take 18 months - 2 years to include 10 patients in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Lack of consent.
2. Known hypersensitivity to amide local anaesthetics.
3. History of seizures or neurological disorders.
4. Presence of blood-clotting disorders or blood dyscrasias.
5. Local congenital abnormalities/infection that contraindicates regional anaesthetic technique.
6. Technically difficult to administer the caudal - epidural block.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified