Continous Lumbar Plexus Block in Children

Not Applicable

Terminated

• Conditions: Pediatric Anesthesia; Pain, Postoperative; Regional Anesthesia
• Interventions: Other: LPB

• Registration Number: NCT03450096
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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

Detailed Description

Paediatric patients undergoing orthopaedic surgery can experience severe pain in the postoperative period. When pain interferes with mobilization and joint movement, the rehabilitation phase is prolonged and painful. Approximately 13% of the children undergoing orthopaedic surgery report symptoms of chronic pain. Therefore, optimal pain treatment should be provided during and after the surgical procedure.

Intravenous opioids or continuous epidural blocks are commonly used for postoperative pain treatment after open hip and femoral surgery. However, side effects like nausea and vomiting, urinary retention, or pruritus are often related to these treatments.

Lumbar plexus blocks (LPB) are a safe and effective alternative for postoperative treatment after hip and femoral surgery. Single injection LPB techniques have shown to provide good pain relief during the early postoperative period in children. Paediatric patients might also benefit from a catheter technique giving a prolonged postoperative analgesia. LPB provide simultaneous sensory blocks of the femoral nerve and the obturator nerve. Both nerves are primarily responsible for the innervation to the femoral shaft, hip joint and the pelvic bones. In contrast to epidural anesthesia techniques, LPB has only unilateral effect. Patients therefore achieve higher mobilization levels, resulting in early rehabilitation.

Several ultrasound-guided lumbar plexus block techniques have been described in the past. The Shamrock technique is a new LPB-technique that has shown to improve visualization of the lumbar plexus, surrounding anatomy, and injection needle. The improved visualization can facilitate block performance and improve safety. A catheter technique will be used for LPB to provide prolonged postoperative analgesia.

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.

Study Timeline

• Study First Submitted: 2018-02-16
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-03-01
• Study Start: 2018-06-05
• Status Verified: 2022-05
• Primary Completion: 2022-05-16
• Study Completion: 2022-05-16
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• 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
• 8-16 year old with legal guardians providing written informed consent.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	LPB	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

Primary Outcome Measures

Name	Time	Method
Cumulative opioid consumption (in mg/kg)	24 hours	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

Secondary Outcome Measures

Name	Time	Method
Satisfaction of patients	48 hours	Satisfaction of patients measured via questionnaire
Occurrence of vomiting, nausea and pruritus	48 hours	Occurrence of vomiting, nausea and pruritus recorded in patient data management system
Time to first opioid requirement	4 hours	Time to first opioid requirement
Total opioids consumption	up to 48 hours	Total opioids consumption during 48 hours (in time periods 0-12 hours, 12-24 hours, 24-36 hours, and 36-48 hours)

Trial Locations

Locations (1)

University Hospital Bern; 🇨🇭 Bern, Switzerland