Regional AnesthesiaNCT03450096
Continous Lumbar Plexus Block in Children
A study testing LPB in people with Regional Anesthesia and Pediatric Anesthesia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Regional Anesthesia, Pediatric Anesthesia, Pain, Postoperative
- What is being tested?
- LPB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Jun 2018to 16 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- LPB
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPBOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (4)
Time to first opioid requirement
Time to first opioid requirement
Measured: 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)
Measured: up to 48 hours
Satisfaction of patients
Satisfaction of patients measured via questionnaire
Measured: 48 hours
Occurrence of vomiting, nausea and pruritus
Occurrence of vomiting, nausea and pruritus recorded in patient data management system
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start5 Jun 2018
- Primary completion16 May 2022
- Study completion16 May 2022
Why it stopped: Too difficult to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lutz Lehmann, PD Dr. med., Study chair, Department Anesthesia and Pain Therapy, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450096
- Sponsor's protocol ID
- LPB in Children
- Status last verified
- May 2022
- First submitted
- 16 Feb 2018
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Lumbar Plexus Block Using Shamrock-technique for Postoperative Pain Treatment After Open Hip and Femoral Surgery in Children
- ClinicalTrials.gov ID
- NCT03450096
- Acronym / sponsor ID
- LPB in Children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too difficult to recruit patients
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Other: LPBA 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 |
| 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 |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LPBA 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 | Treatment group |
Primary outcome
Cumulative opioid consumption (in mg/kg)
Time frame: 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
4 secondary outcomes
Time to first opioid requirement
Time frame: 4 hours
Total opioids consumption
Time frame: up to 48 hours
Satisfaction of patients
Time frame: 48 hours
Occurrence of vomiting, nausea and pruritus
Time frame: 48 hours
Results and safety
The study was stopped early (reason given: Too difficult to recruit patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lutz Lehmann, PD Dr. med. study chair
Department Anesthesia and Pain Therapy, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LPB in people with Regional Anesthesia and Pediatric Anesthesia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Too difficult to recruit patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative opioid consumption (in mg/kg) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.