Orthopedic DisorderNCT04138264
Opioid Counseling Following Orthopaedic Surgery
A study testing Preoperative opioid counseling in people with Orthopedic Disorder, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Postoperative pain management and opioid consumption following outpatient orthopaedic surgery may be influenced by a number of variables including knowledge of safe opioid use. A prospective randomized study is designed to understand the effect of preoperative opioid counseling on postoperative opioid consumption and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- Preoperative opioid counseling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2018to 1 May 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing shoulder, elbow, wrist, knee, foot, and/or ankle surgery
Who cannot join
- male of female less than 18 years old
- patients schedule to undergo inpatient procedures
- patients undergoing surgeries distal to the wrist
- patients undergoing surgeries under local anesthesia only
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid Consumption After Orthopaedic Surgery: Prospective Randomized Trial on the Effects of Pre-Operative Counseling
Postoperative pain management and opioid consumption following outpatient orthopaedic surgery may be influenced by a number of variables including knowledge of safe opioid use. A prospective randomized study is designed to understand the effect of preoperative opioid counseling on postoperative opioid consumption and the typical opioid consumption patterns following common outpatient orthopaedic surgeries. The hypothesis was that patients who received preoperative opioid counseling will consume less postoperative opioid medication and experience greater satisfaction with pain management.
- Conditions
- Orthopedic Disorder
- Being tested
- Preoperative opioid counseling
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative opioid counselingOther
preoperative counseling consists of education with a brief multi-media presentation in the preoperative area on the day of surgery using a handheld tablet. The message of the preoperative counseling consisted of: 1) Background on the opioid epidemic including basic facts and consequences, 2) Description of risk factors for opioid abuse and how to consume opioids safely, 3) Information on the specific opioid the patient was prescribed and the anticipated amount and duration of use postoperatively, 4) Encouraging the use of non-opioid therapy prior to taking the prescribed opioids or quickly transitioning to non-opioid medications postoperatively, and 5) Contact information and instructions to call if the patient experienced any adverse events and/or if additional pain medication is needed.
| Study group | Role | What they receive |
|---|---|---|
| Peroperative counseling | Active comparator | Not described Receives: Other: Preoperative opioid counseling |
| No preoperative counseling | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pills consumed
Patients asked to keep daily diary which includes number of pills consumed during the post-operative period
Measured: Up to 6 weeks
Secondary outcomes (3)
Morphine equivalents (MEQ)
MEQs is a standardized method of comparing different types of pain medication with a gold-standard. All pain medication can be converted to MEQs
Measured: Up to 6 weeks
Visual Analog Scale (pain) Pain
Pain as reported by patients on a daily basis via diaries
Measured: Up to 6 weeks
Patient satisfaction with pain management: 5 point Likert Scale
Satisfaction with pain management as reported daily by patients using a 5 point Likert Scale
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start19 Jun 2018
- Primary completion2 Nov 2018
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138264
- Sponsor's protocol ID
- Ilyas2019
- Status last verified
- Oct 2019
- First submitted
- 21 Oct 2019
- Last updated
- 24 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Consumption After Orthopaedic Surgery: Prospective Randomized Trial on the Effects of Pre-Operative Counseling
- ClinicalTrials.gov ID
- NCT04138264
- Acronym / sponsor ID
- Ilyas2019
- Conditions
- Orthopedic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 24 Oct 2019 (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.
Postoperative pain management and opioid consumption following outpatient orthopaedic surgery may be influenced by a number of variables including knowledge of safe opioid use. A prospective randomized study is designed to understand the effect of preoperative opioid counseling on postoperative opioid consumption and the typical opioid consumption patterns following common outpatient orthopaedic surgeries. The hypothesis was that patients who received preoperative opioid counseling will consume less postoperative opioid medication and experience greater satisfaction with pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peroperative counseling | Active comparator | Other: Preoperative opioid counseling |
| No preoperative counseling | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing shoulder, elbow, wrist, knee, foot, and/or ankle surgery
Key exclusion criteria (4 listed)
- male of female less than 18 years old
- patients schedule to undergo inpatient procedures
- patients undergoing surgeries distal to the wrist
- patients undergoing surgeries under local anesthesia only
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 |
|---|---|---|
| Preoperative opioid counselingpreoperative counseling consists of education with a brief multi-media presentation in the preoperative area on the day of surgery using a handheld tablet. The message of the preoperative counseling consisted of: 1) Background on the opioid epidemic including basic facts and consequences, 2) Description of risk factors for opioid abuse and how to consume opioids safely, 3) Information on the specific opioid the patient was prescribed and the anticipated amount and duration of use postoperatively, 4) Encouraging the use of non-opioid therapy prior to taking the prescribed opioids or quickly transitioning to non-opioid medications postoperatively, and 5) Contact information and instructions to call if the patient experienced any adverse events and/or if additional pain medication is needed. | Other | Peroperative counseling |
Primary outcome
Number of pills consumed
Time frame: Up to 6 weeks
Patients asked to keep daily diary which includes number of pills consumed during the post-operative period
3 secondary outcomes
Morphine equivalents (MEQ)
Time frame: Up to 6 weeks
Visual Analog Scale (pain) Pain
Time frame: Up to 6 weeks
Patient satisfaction with pain management: 5 point Likert Scale
Time frame: Up to 6 weeks
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 24 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative opioid counseling in people with Orthopedic Disorder, run by Rothman Institute Orthopaedics 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 1 inclusion and 4 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 24 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 pills consumed (time frame: Up to 6 weeks). 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 24 Oct 2019.