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Trial record 14 of 57 for:    Recruiting, Not yet recruiting, Available Studies | Arthroscopy

Opioid Consumption After Knee Arthroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03299920
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Giorgio Veneziano, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Surgical Procedure, Unspecified Orthopedic Disorder Other: Standardized instructions Other: Conventional instructions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Opioid Consumption After Knee Arthroscopy With and Without the Use of New Standardized Patient/Family Instructions for Postoperative Analgesic Use
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

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.

Control
Patient will receive conventional instructions on postoperative pain management.
Other: Conventional instructions
Usual post-operative instructions.




Primary Outcome Measures :
  1. Number of opioid medication doses taken [ Time Frame: Post-op day 5 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299920


Contacts
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Contact: Julie Rice, RN 6143553142 julie.rice@nationwidechildrens.org
Contact: Heather Dellinger, RN 6147222997 heather.dellinger@nationwidechildrens.org

Locations
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United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Julie Rice, RN    614-355-3142    julie.rice@nationwidechildrens.org   
Sponsors and Collaborators
Giorgio Veneziano
Investigators
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Principal Investigator: Giorgio Veneziano, MD Nationwide Children's Hospital

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Responsible Party: Giorgio Veneziano, Director, Regional Anesthesia Service, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03299920     History of Changes
Other Study ID Numbers: IRB17-00710
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Musculoskeletal Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs