search
Back to results

Continous Lumbar Plexus Block in Children

Primary Purpose

Regional Anesthesia, Pediatric Anesthesia, Pain, Postoperative

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
LPB
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Regional Anesthesia

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Treatment group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to first opioid requirement
Time to first opioid requirement
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)
Satisfaction of patients
Satisfaction of patients measured via questionnaire
Occurrence of vomiting, nausea and pruritus
Occurrence of vomiting, nausea and pruritus recorded in patient data management system

Full Information

First Posted
February 16, 2018
Last Updated
May 17, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
search

1. Study Identification

Unique Protocol Identification Number
NCT03450096
Brief Title
Continous Lumbar Plexus Block in Children
Official Title
Continuous Lumbar Plexus Block Using Shamrock-technique for Postoperative Pain Treatment After Open Hip and Femoral Surgery in Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Too difficult to recruit patients
Study Start Date
June 5, 2018 (Actual)
Primary Completion Date
May 16, 2022 (Actual)
Study Completion Date
May 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Anesthesia, Pediatric Anesthesia, Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
LPB
Intervention Description
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 Measure Information:
Title
Cumulative opioid consumption (in mg/kg)
Description
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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Time to first opioid requirement
Description
Time to first opioid requirement
Time Frame
4 hours
Title
Total opioids consumption
Description
Total opioids consumption during 48 hours (in time periods 0-12 hours, 12-24 hours, 24-36 hours, and 36-48 hours)
Time Frame
up to 48 hours
Title
Satisfaction of patients
Description
Satisfaction of patients measured via questionnaire
Time Frame
48 hours
Title
Occurrence of vomiting, nausea and pruritus
Description
Occurrence of vomiting, nausea and pruritus recorded in patient data management system
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lutz Lehmann, PD Dr. med.
Organizational Affiliation
Department Anesthesia and Pain Therapy, University Hospital Bern
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Continous Lumbar Plexus Block in Children

We'll reach out to this number within 24 hrs