Continous Lumbar Plexus Block in Children

Continuous Lumbar Plexus Block Using Shamrock-technique for Postoperative Pain Treatment After Open Hip and Femoral Surgery in Children

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

Study Overview

• Status: Terminated
• Conditions: Pain, Postoperative; Pediatric Anesthesia; Regional Anesthesia
• Intervention / Treatment: Other: LPB

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Treatment group; 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; 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
NO_INTERVENTION: Control group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Study Chair: Lutz Lehmann, PD Dr. med., Department Anesthesia and Pain Therapy, University Hospital Bern

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 5, 2018
• Primary Completion (ACTUAL): May 16, 2022
• Study Completion (ACTUAL): May 16, 2022

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (ACTUAL): March 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: LPB in Children

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No