Regional Anesthesia in Pediatric Orthopaedic Patients

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04669145
• Other study ID #: 2020.403
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 24, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: April 2023
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: August 1, 2024
• Est. primary completion date: May 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia
• Anesthesia, Local
• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Ochsner Medical Center	Jefferson	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Ochsner Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Consumption	Amount of opioid medications taken for pain control.	For first 48 hours post-operatively.
Secondary	Opioid Consumption	Amount of opioid medications taken for pain control.	Through 12 hours post-operatively.
Secondary	Opioid Consumption	Amount of opioid medications taken for pain control.	Through 24 hours post-operatively.
Secondary	Opioid Consumption	Amount of opioid medications taken for pain control.	Through 36 hours post-operatively.
Secondary	Opioid Consumption	Amount of opioid medications taken for pain control.	Through 48 hours week post-operatively.
Secondary	Opioid Consumption	Amount of opioid medications taken for pain control.	Through 72 hours post-operatively.
Secondary	Opioid Consumption	Amount of opioid medications taken for pain control.	Through 96 hours post-operatively.
Secondary	Opioid Consumption	Amount of opioid medications taken for pain control.	Through 120 hours post-operatively.
Secondary	Opioid Consumption	Amount of opioid medications taken for pain control.	Through 144 hours post-operatively.
Secondary	Opioid Consumption	Amount of opioid medications taken for pain control.	Through 168 hours post-operatively.
Secondary	Emergency Room Visits	Emergency room visits due to poor pain control.	Within 2 weeks post-operatively.
Secondary	Pain Scores	Universal Pain Assessment tool will be used. The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain.	At 12 hours post-operatively.
Secondary	Pain Scores	Universal Pain Assessment tool will be used. The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain.	At 24 hours post-operatively.
Secondary	Pain Scores	Universal Pain Assessment tool will be used. The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain.	At 36 hours post-operatively.
Secondary	Pain Scores	Universal Pain Assessment tool will be used. The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain.	At 48 hours post-operatively.
Secondary	Pain Scores	Universal Pain Assessment tool will be used.The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain.	At 72 hours post-operatively.
Secondary	Pain Scores	Universal Pain Assessment tool will be used.The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain.	At 96 hours post-operatively.
Secondary	Pain Scores	Universal Pain Assessment tool will be used.The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain.	At 120 hours post-operatively.
Secondary	Pain Scores	Universal Pain Assessment tool will be used.The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain.	At 144 hours post-operatively.
Secondary	Pain Scores	Universal Pain Assessment tool will be used.The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain.	At 168 hours post-operatively.
Secondary	Pain Scores	Universal Pain Assessment tool will be used. The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain.	At 2 weeks post-operatively.