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

Clinical trial of the investigational medicinal product, local anaesthetic levo-bupivacaine in infants 3 - 6 months post natal age. - Ratifying dosage and duration of levo-bupivacaine infusion in infants.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000393-34-GB

Enrollment

Registered

2015-04-30

Start date

2015-06-01

Completion date

Unknown

Last updated

2019-06-30

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

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: 100

Interventions

Trade Name: Chirocaine Product Name: Levobupivacaine Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Levobupivacaine

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: There are no secondary questions.; Main Objective: The main objective is to ratify the safety of the present standard protocol for caudal-epidural levobupivacaine in infants three to six months age. A bolus of levo-bupivacaine will be used followed by an infusion in the same space, after one hour of the bolus. This study will measure plasma levels of levo-bupivacaine upto 72 hours, though the infusion will stop at 48 hours, to ensure that toxic levels are not reached in plasma. It will help to confirm the pharmacokinetic model and the information will also be used to manage other infants undergoing other major surgery and requiring this method of pain relief. ; Primary end point(s): The primary outcome is the safety of the current practise of use of levo-bupivacaine. The measure is plasma levels of levo-bupivacaine when given as a bolus dose of levo-bupivacaine via the caudal-epidural route followed by an infusion after one hour of the bouls and continued for 48 hours. The study looks to see whether this remains within the recommended safe plasma levels.	—

Measure

Time frame

Secondary Objective: There are no secondary questions.; Main Objective: The main objective is to ratify the safety of the present standard protocol for caudal-epidural levobupivacaine in infants three to six months age. A bolus of levo-bupivacaine will be used followed by an infusion in the same space, after one hour of the bolus. This study will measure plasma levels of levo-bupivacaine upto 72 hours, though the infusion will stop at 48 hours, to ensure that toxic levels are not reached in plasma. It will help to confirm the pharmacokinetic model and the information will also be used to manage other infants undergoing other major surgery and requiring this method of pain relief. ; Primary end point(s): The primary outcome is the safety of the current practise of use of levo-bupivacaine. The measure is plasma levels of levo-bupivacaine when given as a bolus dose of levo-bupivacaine via the caudal-epidural route followed by an infusion after one hour of the bouls and continued for 48 hours. The study looks to see whether this remains within the recommended safe plasma levels.

—

Secondary

Measure	Time frame
Secondary end point(s): There are no secondary end points.	—

Countries

United Kingdom

Contacts

Public ContactDr Lynne Webster

Central Manchester University Hospitals NHS Foundation Trust

lynne.webster@cmft.nhs.uk01612764125

Outcome results

None listed

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