NCT03299920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2018

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2018

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

September 28, 2017

Last Update Submit

October 22, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of opioid medication doses taken

    Post-op day 5

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Control

OTHER

Patient will receive conventional instructions on postoperative pain management.

Other: Conventional instructions

Interventions

Specific instructions related to peripheral nerve block.

Intervention

Usual post-operative instructions.

Control

Eligibility Criteria

AgeUp to 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient of age less than 20 years presenting to NCH main campus for knee arthroscopy
  • American Society of Anesthesiology physical status I or II

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Giorgio Veneziano, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Regional Anesthesia Service

Study Record Dates

First Submitted

September 28, 2017

First Posted

October 3, 2017

Study Start

September 18, 2017

Primary Completion

October 22, 2018

Study Completion

October 28, 2018

Last Updated

October 23, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations