Opioid Consumption After Knee Arthroscopy

Opioid Consumption After Knee Arthroscopy With and Without the Use of New Standardized Patient/Family Instructions for Postoperative Analgesic Use

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.

Study Overview

• Status: Completed
• Conditions: Orthopedic Disorder; Surgical Procedure, Unspecified
• Intervention / Treatment: Other: Standardized instructions; Other: Conventional instructions

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Patients will receive standardized instruction from a study nurse, tailored to understanding pain management after nerve blocks and maximizing utilization of non-opioid analgesics.	Other: Standardized instructions; Specific instructions related to peripheral nerve block.
Other: Control; Patient will receive conventional instructions on postoperative pain management.	Other: Conventional instructions; Usual post-operative instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of opioid medication doses taken	Post-op day 5

Collaborators and Investigators

• Sponsor: Giorgio Veneziano
• Investigators: Principal Investigator: Giorgio Veneziano, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2017
• Primary Completion (Actual): October 22, 2018
• Study Completion (Actual): October 28, 2018

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: IRB17-00710

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No