Regional Anesthesia in Pediatric Orthopaedic Patients

Ochsner Health System

Status and phase: Completed; Phase 3; Phase 2

Conditions: Orthopedic Disorder; Anesthesia, Local; Anesthesia

Treatments: Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04669145

2020.403

Details and patient eligibility

About

To identify the benefits from regional anesthesia use as pain management in the pediatric population by delineating the differences in efficacy of continuous nerve blockade versus single-shot techniques after pediatric orthopaedic limb procedures. By doing this, the investigators can determine if specific anesthetic techniques should become a standard of care in pain management for the pediatric population and supersede the need for opioid medication.

Enrollment: 24 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing primary orthopaedic limb surgery
• Outpatient orthopaedic surgeries
• Patients undergoing orthopaedic surgery who would normally receive regional anesthesia

Exclusion criteria

• Patients younger than 5 years of ago or older than 18 years of age
• Revision orthopaedic surgeries
• Spinal orthopaedic surgeries
• Orthopaedic surgeries where the standard of care for type of regional anesthesia has been established (continuous regional for ACL reconstruction)
• Patients with the inability to articulate pain scores
• Inpatient orthopaedic surgeries
• Patients undergoing orthopaedic limb surgery with risk of compartment syndrome (i.e. acute supracondylar humerus fractures)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Continuous Regional Anesthesia Lower Limb Surgery

Experimental group

Description:

Various types of regional anesthesia blocks will be performed based on the patient's injuries including fascia iliaca plane blocks, femoral nerve blocks, adductor canal blocks, popliteal approach sciatic nerve blocks, and saphenous nerve blocks A catheter will be placed for the given block for 48 hours. Those patients undergoing lower limb orthopaedic surgery will be randomized into single shot or continuous (catheter) regional anesthesia.

Treatment:

Drug: Ropivacaine

Single Shot Regional Anesthesia Lower Limb Surgery

Experimental group

Description:

Various types of regional anesthesia blocks will be performed based on the patient's injuries including fascia iliaca plane blocks, femoral nerve blocks, adductor canal blocks, popliteal approach sciatic nerve blocks, and saphenous nerve blocks. These blocks will be given via a single dose or "single shot". Those patients undergoing lower limb orthopaedic surgery will be randomized into single shot or continuous (catheter) regional anesthesia.

Treatment:

Drug: Ropivacaine

Continuous Regional Anesthesia Upper Limb Surgery

Experimental group

Description:

Various types of regional anesthesia blocks involving the brachial plexus will be performed based on the patient's injuries. A catheter will be placed for the given block for 48 hours. Those patients undergoing upper limb orthopaedic surgery will be randomized into single shot or continuous (catheter) regional anesthesia.

Treatment:

Drug: Ropivacaine

Single Shot Regional Anesthesia Upper Limb Surgery

Experimental group

Description:

Various types of regional anesthesia blocks involving the brachial plexus will be performed based on the patient's injuries. A catheter will be placed for the given block for 48 hours. Those patients undergoing upper limb orthopaedic surgery will be randomized into single shot or continuous (catheter) regional anesthesia.

Treatment:

Drug: Ropivacaine