Clinical trial

Single-Shot Versus Continuous Regional Anesthesia for Treating Acute Postoperative Pain in Pediatric Orthopaedic Surgery: A Prospective Randomized Trial

Name

2020.403

Description

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.

Trial arms

Trial start

2021-06-24

Estimated PCD

2024-05-28

Trial end

2024-08-01

Status

Recruiting

Phase

Early phase I

Treatment

Ropivacaine

Dosing and volume will vary based on type of block used and weight of patient because of the pediatric population in the study.

Arms:

Continuous Regional Anesthesia Lower Limb Surgery, Continuous Regional Anesthesia Upper Limb Surgery, Single Shot Regional Anesthesia Lower Limb Surgery, Single Shot Regional Anesthesia Upper Limb Surgery

Size

Primary endpoint

Opioid Consumption

For first 48 hours post-operatively.

Eligibility criteria

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 88, 'type': 'ESTIMATED'}}

Updated at

2023-04-24

1 organization

1 product

3 indications

Organization

Ochsner Health System

Product

Indication

Indication

Indication