Back to resultsOpioid Consumption After Knee Arthroscopy
Primary Purpose
Surgical Procedure, Unspecified, Orthopedic Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standardized instructions
Conventional instructions
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Procedure, Unspecified
Eligibility Criteria
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
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Intervention
Control
Arm Description
Patients will receive standardized instruction from a study nurse, tailored to understanding pain management after nerve blocks and maximizing utilization of non-opioid analgesics.
Patient will receive conventional instructions on postoperative pain management.
Outcomes
Primary Outcome Measures
Number of opioid medication doses taken
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03299920
Brief Title
Opioid Consumption After Knee Arthroscopy
Official Title
Opioid Consumption After Knee Arthroscopy With and Without the Use of New Standardized Patient/Family Instructions for Postoperative Analgesic Use
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
October 22, 2018 (Actual)
Study Completion Date
October 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Giorgio Veneziano
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Procedure, Unspecified, Orthopedic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Patients will receive standardized instruction from a study nurse, tailored to understanding pain management after nerve blocks and maximizing utilization of non-opioid analgesics.
Arm Title
Control
Arm Type
Other
Arm Description
Patient will receive conventional instructions on postoperative pain management.
Intervention Type
Other
Intervention Name(s)
Standardized instructions
Intervention Description
Specific instructions related to peripheral nerve block.
Intervention Type
Other
Intervention Name(s)
Conventional instructions
Intervention Description
Usual post-operative instructions.
Primary Outcome Measure Information:
Title
Number of opioid medication doses taken
Time Frame
Post-op day 5
10. Eligibility
Sex
All
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorgio Veneziano, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Opioid Consumption After Knee Arthroscopy
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