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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03299920
Other study ID # IRB17-00710
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 18, 2017
Est. completion date October 28, 2018

Study information

Verified date October 2019
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, randomized trial of patients undergoing outpatient knee arthroscopy surgery and receiving a peripheral nerve block. Patients will be randomized to either receive standard discharge teaching or specialized teaching regarding pain control following a nerve block. Patients will be asked to complete a journal for 5 days recording their pain scores, opioid medication usage, and overall satisfaction with pain control at home.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date October 28, 2018
Est. primary completion date October 22, 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 20 Years
Eligibility Inclusion Criteria:

- Patient of age less than 20 years presenting to NCH main campus for knee arthroscopy

- American Society of Anesthesiology physical status I or II

Exclusion Criteria:

- Anterior cruciate ligament repair or reconstruction

- Admission to hospital

- Inability or refusal to receive femoral nerve blockade

- Body mass index > 99 percentile

- Hydrocodone allergy or intolerance

- Acetaminophen allergy or intolerance

- Non-steroidal anti-inflammatory allergy or intolerance

- Pregnancy

- Interpreter requirement

- Opioid use within 3 months prior to surgery

- Previous knee surgery at WSC after Jan. 1, 2017

- History of opioid abuse or dependence

Study Design


Intervention

Other:
Standardized instructions
Specific instructions related to peripheral nerve block.
Conventional instructions
Usual post-operative instructions.

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Giorgio Veneziano

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of opioid medication doses taken Post-op day 5
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