Continous Lumbar Plexus Block in Children

NCT03450096 | Terminated DMC

• 1 other identifier: LPB in Children
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Randomised controlled prospective trial with 2 groups (active group with Lumbar plexus block (LPB)-catheter vs control group). In a randomized controlled trial, the investigators will investigate under controlled circumstances the effect of a LPB-catheter placed with ultrasound guided "Shamrock"-technique to improve postoperative pain treatment after unilateral open hip and femoral surgery in paediatric patients. The investigators will investigate the effect on opioid consumption and the reduction of opioid related side effects during the first 24 postoperative hours

Conditions

Regional Anesthesia; Pediatric Anesthesia; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Cumulative opioid consumption (in mg/kg)

  Cumulative opioid consumption (in mg/kg) in the first postoperative 24 hours in an active treatment group using LPB with a bolus of ropivacaine 0.375% and a continuous LPB-catheter infusion with ropivacaine 0.2 % compared with a control group without LPB

  24 hours

Secondary Outcomes (4)

• Time to first opioid requirement

  4 hours

• Total opioids consumption

  up to 48 hours

• Satisfaction of patients

  48 hours

• Occurrence of vomiting, nausea and pruritus

  48 hours

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

A bolus injection for LPB of 0.5 ml/kg ropivacaine 3.75 mg/ml (max 40 ml will be performed and the catheter will be placed before surgical interventions. A continuous perineural infusion of 0.2 ml/kg/h ropivacaine 0.2%, starting immediately after initial bolus injection will be then administered

Other: LPB

Control group

NO INTERVENTION

Patients in the control group (and in the active treatment group) will receive an opioid-based analgesia with a hydromorphone-patient controlled analgesia (PCA) depending on their analgesic demand

Interventions

LPB OTHER

A bolus injection for LPB of 0.5 ml/kg ropivacaine 3.75 mg/ml (max 40 ml will be performed and the catheter will be placed before surgical interventions. A continuous perineural infusion of 0.2 ml/kg/h ropivacaine 0.2%, starting immediately after initial bolus injection will be then administered

Treatment group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Paediatric patients undergoing elective unilateral open hip and femoral surgery requiring general anaesthesia with intubation at the University Hospital - Inselspital in Bern.
• American Society of Anesthesiologist (ASA) physical status 1-3
• year old with legal guardians providing written informed consent.

You may not qualify if:

• Obesity (BMI 30 kg/m2)
• Infeasibility to use a PCA pump
• Known or suspected infection of the skin at the site of needle puncture area
• Known allergy to ropivacaine
• Severe spine deformity
• Neuromuscular disease
• Coagulopathy.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Lutz Lehmann, PD Dr. med.

  Department Anesthesia and Pain Therapy, University Hospital Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: March 1, 2018
• Study Start: June 5, 2018
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)