Surgical Procedure, UnspecifiedNCT03299920
Opioid Consumption After Knee Arthroscopy
A study testing Standardized instructions and Conventional instructions in people with Surgical Procedure, Unspecified and Orthopedic Disorder, run by Giorgio Veneziano at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Surgical Procedure, Unspecified, Orthopedic Disorder
- What is being tested?
- Standardized instructions and Conventional instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2017to 28 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient of age less than 20 years presenting to NCH main campus for knee arthroscopy
- American Society of Anesthesiology physical status I or II
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: 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.
- Being tested
- Standardized instructions, Conventional instructions
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized instructionsOther
Specific instructions related to peripheral nerve block.
Conventional instructionsOther
Usual post-operative instructions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standardized instructions |
| Control | Other | Patient will receive conventional instructions on postoperative pain management. Receives: Other: Conventional instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of opioid medication doses taken
Measured: Post-op day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start18 Sep 2017
- Primary completion22 Oct 2018
- Study completion28 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giorgio Veneziano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giorgio Veneziano, Nationwide Children's Hospital
- Investigators
- Giorgio Veneziano, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299920
- Sponsor's protocol ID
- IRB17-00710
- Status last verified
- Oct 2019
- First submitted
- 28 Sep 2017
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Consumption After Knee Arthroscopy With and Without the Use of New Standardized Patient/Family Instructions for Postoperative Analgesic Use
- ClinicalTrials.gov ID
- NCT03299920
- Acronym / sponsor ID
- IRB17-00710
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Giorgio VenezianoUniversity, hospital or other
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 22 Oct 2018 (actual)
- Study completion
- 28 Oct 2018 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Standardized instructionsPatients will receive standardized instruction from a study nurse, tailored to understanding pain management after nerve blocks and maximizing utilization of non-opioid analgesics. |
| Control | Other | Other: Conventional instructionsPatient will receive conventional instructions on postoperative pain management. |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patient of age less than 20 years presenting to NCH main campus for knee arthroscopy
- American Society of Anesthesiology physical status I or II
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized instructionsSpecific instructions related to peripheral nerve block. | Other | Intervention |
| Conventional instructionsUsual post-operative instructions. | Other | Control |
Primary outcome
Number of opioid medication doses taken
Time frame: Post-op day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgio Veneziano, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized instructions and Conventional instructions in people with Surgical Procedure, Unspecified and Orthopedic Disorder, run by Giorgio Veneziano at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of opioid medication doses taken (time frame: Post-op day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.