Clinical trial NCT03450096: 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
Overall status: TERMINATED
Phase: NA
Conditions: Regional Anesthesia
Pediatric Anesthesia
Pain, Postoperative
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 33
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cumulative opioid consumption (in mg/kg)
timeFrame: 24 hours
Secondary outcomes:
measure: Time to first opioid requirement
timeFrame: 4 hours
measure: Total opioids consumption
timeFrame: up to 48 hours
measure: Satisfaction of patients
timeFrame: 48 hours
measure: Occurrence of vomiting, nausea and pruritus
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
affiliation: Department Anesthesia and Pain Therapy, University Hospital Bern
name: Lutz Lehmann, PD Dr. med.
role: STUDY_CHAIR
References: