Ambulatory Hand SurgeryNCT03219177
Patient Education and Use of Post Operative Pain Medication in Ambulatory Hand Surgery: a Randomized Controlled Trial
A study testing Patient education regarding indications for opioid use and side effects of opioid use after hand surgery in people with Ambulatory Hand Surgery, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
There is a current opioid epidemic in the United States partially fueled by excess prescribing practices after surgery. The objective of this study is to decrease the amount of opioids needed after ambulatory hand surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ambulatory Hand Surgery
- What is being tested?
- Patient education regarding indications for opioid use and side effects of opioid use after hand surgery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 6 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English Speaking: must be able to communicate over the phone or by email to perform questionnaires
- Primary elective ambulatory hand surgery (bony or soft tissue)
- Bony: Scaphoidectomy/ligament reconstruction tendon interposition (LRTI), Arthrodesis, Arthroplasty Soft Tissue: Carpal tunnel release (CTR), Trigger Finger (TF), DeQuervain's (DQ), Cyst removal, Cubital tunnel, Dupuytren's, tendon transfer, arthroscopy of wrist or elbow
Who cannot join
- Disability or preop pain in ipsilateral upper extremity from a secondary condition not related to the study procedure
- Allergy or inability to consume oxycodone, Percocet or Vicodin due to a particular health state
- Current Substance Abuse
- HSS employees
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Patient Education and Use of Postoperative Pain Medication in Ambulatory Hand Surgery: a Randomized Controlled Trial
There is a current opioid epidemic in the United States partially fueled by excess prescribing practices after surgery. The objective of this study is to decrease the amount of opioids needed after ambulatory hand surgery. In this randomized control trial, patients will be randomized into a patient education group and into a control group. The education group will be provided with a pre-operative video detailing proper indications for opioid use after hand surgery, alternative pain management strategies to try before using prescription opioid medications, and side effects associated with opioid use. Patients will also receive information on the current opioid epidemic. Patients will be reminded of the information given pre-operatively after surgery in the post-anesthesia care unit. The control group will not receive pre-operative education and will only receive standard of care post-operative counseling by nursing in the post-anesthesia care unit. All patients will be given a pain log, pain medication diary and participate in phone/email surveys to determine number of opioid pills taken, pain levels, and satisfaction with surgery. The investigators hypothesize that the education group will have decreased opioid intake and increased patient satisfaction compared to the control group.
- Conditions
- Ambulatory Hand Surgery
- Being tested
- Patient education regarding indications for opioid use and side effects of opioid use after hand surgery, Standard of care post-operative counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education regarding indications for opioid use and side effects of opioid use after hand surgeryBehavioural
Patients in the active education group will be given information pre-operatively on the current opioid epidemic, alternative pain management strategies that should be tried before proceeding to prescription opioid use, appropriate indications for opioid use, and side effects of opioids.This information will be reinforced by the research coordinator and nursing staff in the post-anesthesia care unit.
Standard of care post-operative counselingOther
Patients will receive standard of care post-operative counseling. They will not be given pre or post-operative opioid education.
| Study group | Role | What they receive |
|---|---|---|
| Patient education group | Experimental | Not described Receives: Behavioral: Patient education regarding indications for opioid use and side effects of opioid use after hand surgery |
| Control- Standard of care counseling | Active comparator | Not described Receives: Other: Standard of care post-operative counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of prescription opioids used postoperatively
Measured: Within 14 days of surgery
Secondary outcomes (8)
Patient satisfaction
This will be measured on a Likert scale, as used in most orthopedics research.
Measured: Post-op day 3, 8, and 15
Pain level
Numeric Rating Scale pain scores
Measured: Post-op day 3, 8, 15
Surgical factors
Type of surgery, length of surgery, type and amount of anesthesia
Measured: Recorded on day of surgery
Pain Catastrophization Score
This validated scale is one of the most widely used instruments to evaluate catastrophic thinking related to pain. It specifically evaluates patients' feelings of helplessness and frequency of rumination on and magnification of pain.
Measured: Measured pre-operatively
Mindfulness Attention Awareness Scale Score
This validated scale assesses dispositional mindfulness and has been shown to tap a unique quality of consciousness that is associated with self-regulation and well-being constructs.
Measured: Measured pre-operatively
Adverse reactions to pain medication
Side effects of opioid and non-opioid medications will be assessed
Measured: Post-op day 3, 8, 15
Prescriptions filled and refilled
We will assess whether patients both initially filled and re-filled their opioid prescriptions
Measured: Post-op day 3, 8, 15
Alternative analgesia used
We will identify if patients use any alternative pain management strategies (i.e., elevation, icing, breathing exercises, mediation, etc.)
Measured: Post-op day 3, 8, 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start15 Jun 2017
- Primary completion6 Dec 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ambulatory Hand SurgeryStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219177
- Sponsor's protocol ID
- 2016-0330
- Status last verified
- Dec 2022
- First submitted
- 13 Jul 2017
- Last updated
- 16 Dec 2022
- 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 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Education and Use of Postoperative Pain Medication in Ambulatory Hand Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03219177
- Acronym / sponsor ID
- 2016-0330
- Conditions
- Ambulatory Hand Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 17 Jul 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.
There is a current opioid epidemic in the United States partially fueled by excess prescribing practices after surgery. The objective of this study is to decrease the amount of opioids needed after ambulatory hand surgery. In this randomized control trial, patients will be randomized into a patient education group and into a control group. The education group will be provided with a pre-operative video detailing proper indications for opioid use after hand surgery, alternative pain management strategies to try before using prescription opioid medications, and side effects associated with opioid use. Patients will also receive information on the current opioid epidemic. Patients will be reminded of the information given pre-operatively after surgery in the post-anesthesia care unit. The control group will not receive pre-operative education and will only receive standard of care post-operative counseling by nursing in the post-anesthesia care unit. All patients will be given a pain log, pain medication diary and participate in phone/email surveys to determine number of opioid pills taken, pain levels, and satisfaction with surgery. The investigators hypothesize that the education group will have decreased opioid intake and increased patient satisfaction compared to the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient education group | Experimental | Behavioral: Patient education regarding indications for opioid use and side effects of opioid use after hand surgery |
| Control- Standard of care counseling | Active comparator | Other: Standard of care post-operative counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English Speaking: must be able to communicate over the phone or by email to perform questionnaires
- Primary elective ambulatory hand surgery (bony or soft tissue)
- Bony: Scaphoidectomy/ligament reconstruction tendon interposition (LRTI), Arthrodesis, Arthroplasty Soft Tissue: Carpal tunnel release (CTR), Trigger Finger (TF), DeQuervain's (DQ), Cyst removal, Cubital tunnel, Dupuytren's, tendon transfer, arthroscopy of wrist or elbow
Key exclusion criteria (4 listed)
- Disability or preop pain in ipsilateral upper extremity from a secondary condition not related to the study procedure
- Allergy or inability to consume oxycodone, Percocet or Vicodin due to a particular health state
- Current Substance Abuse
- HSS employees
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 |
|---|---|---|
| Patient education regarding indications for opioid use and side effects of opioid use after hand surgeryPatients in the active education group will be given information pre-operatively on the current opioid epidemic, alternative pain management strategies that should be tried before proceeding to prescription opioid use, appropriate indications for opioid use, and side effects of opioids.This information will be reinforced by the research coordinator and nursing staff in the post-anesthesia care unit. | Behavioural | Patient education group |
| Standard of care post-operative counselingPatients will receive standard of care post-operative counseling. They will not be given pre or post-operative opioid education. | Other | Control- Standard of care counseling |
Primary outcome
Number of prescription opioids used postoperatively
Time frame: Within 14 days of surgery
8 secondary outcomes
Patient satisfaction
Time frame: Post-op day 3, 8, and 15
Pain level
Time frame: Post-op day 3, 8, 15
Surgical factors
Time frame: Recorded on day of surgery
Pain Catastrophization Score
Time frame: Measured pre-operatively
Mindfulness Attention Awareness Scale Score
Time frame: Measured pre-operatively
Adverse reactions to pain medication
Time frame: Post-op day 3, 8, 15
Prescriptions filled and refilled
Time frame: Post-op day 3, 8, 15
Alternative analgesia used
Time frame: Post-op day 3, 8, 15
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 16 Dec 2022.
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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 Patient education regarding indications for opioid use and side effects of opioid use after hand surgery in people with Ambulatory Hand Surgery, run by Hospital for Special Surgery, New York 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 3 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 16 Dec 2022. 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 prescription opioids used postoperatively (time frame: Within 14 days of surgery). 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 16 Dec 2022.