Post-operative PainNCT03597308
Prospective Pain Study Comparing Different Treatments After Hand Surgery
A study testing 5mg of Oxycodone every 6 hours as needed for pain, 600mg of Ibuprofen every 6 hours as needed for pain and 500mg of Acetaminophen every 6 hours as needed for pain in people with Post-operative Pain, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the efficacy of three different types of pain medication (Oxycodone - an opioid, Ibuprofen - a non-steroidal anti-inflammatory, and Acetaminophen - a non-opioid analgesic) in the management of postoperative pain following single soft tissue procedures of the hand and wrist… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- 5mg of Oxycodone every 6 hours as needed for pain, 600mg of Ibuprofen every 6 hours as needed for pain and 500mg of Acetaminophen every 6 hours as needed for pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2017to 1 Aug 2017
- 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 indicated to undergo primary, unilateral carpal tunnel release or trigger finger release surgery under local anesthesia alone.
- Age eligibility is > 18 years of age.
- Local anesthesia with 1% lidocaine with 1:100,000 epinephrine and Bicarbonate.
Who cannot join
- Bilateral procedures.
- Additional soft tissue or boney procedures performed simultaneously.
- The use of sedation and/or general anesthesia.
- Pediatric patients (age < 18 years).
- Pregnant female patients.
- Non-English speaking patients.
- Known allergies or medical contraindications to Oxycodone, Ibuprofen, Acetaminophen.
- History of chronic pain and/or narcotic use preoperatively.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING OXYCODONE, IBUPROFEN AND ACETAMINOPHEN AFTER WIDE AWAKE HAND SURGERY
The purpose of the study is to evaluate the efficacy of three different types of pain medication (Oxycodone - an opioid, Ibuprofen - a non-steroidal anti-inflammatory, and Acetaminophen - a non-opioid analgesic) in the management of postoperative pain following single soft tissue procedures of the hand and wrist performed exclusively under local anesthesia without sedation. The results of this study will help define optimal prescribing guidelines following the two most common hand surgeries while also potentially validating the use of opioid alternatives post-operatively in order to help mitigate excessive or unnecessary dispensal of opioid analgesics.
- Conditions
- Post-operative Pain
- Being tested
- 5mg of Oxycodone every 6 hours as needed for pain, 600mg of Ibuprofen every 6 hours as needed for pain, 500mg of Acetaminophen every 6 hours as needed for pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5mg of Oxycodone every 6 hours as needed for painDrug
5mg of Oxycodone every 6 hours as needed for pain
600mg of Ibuprofen every 6 hours as needed for painDrug
600mg of Ibuprofen every 6 hours as needed for pain
500mg of Acetaminophen every 6 hours as needed for painDrug
500mg of Acetaminophen every 6 hours as needed for pain
| Study group | Role | What they receive |
|---|---|---|
| Opioid Group | Active comparator | Not described Receives: Drug: 5mg of Oxycodone every 6 hours as needed for pain |
| NSAID group | Active comparator | Not described Receives: Drug: 600mg of Ibuprofen every 6 hours as needed for pain |
| Acetaminophen | Active comparator | Not described Receives: Drug: 500mg of Acetaminophen every 6 hours as needed for pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating Scale for Pain
11-point numeric rating scale (NRS) for pain
Measured: 2 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start17 Mar 2017
- Primary completion14 Jul 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 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
- NCT03597308
- Sponsor's protocol ID
- 2018Ilyas
- Status last verified
- Jul 2018
- First submitted
- 12 Jul 2018
- Last updated
- 24 Jul 2018
- 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 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING OXYCODONE, IBUPROFEN AND ACETAMINOPHEN AFTER WIDE AWAKE HAND SURGERY
- ClinicalTrials.gov ID
- NCT03597308
- Acronym / sponsor ID
- 2018Ilyas
- Conditions
- Post-operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 24 Jul 2018 (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.
The purpose of the study is to evaluate the efficacy of three different types of pain medication (Oxycodone - an opioid, Ibuprofen - a non-steroidal anti-inflammatory, and Acetaminophen - a non-opioid analgesic) in the management of postoperative pain following single soft tissue procedures of the hand and wrist performed exclusively under local anesthesia without sedation. The results of this study will help define optimal prescribing guidelines following the two most common hand surgeries while also potentially validating the use of opioid alternatives post-operatively in order to help mitigate excessive or unnecessary dispensal of opioid analgesics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Opioid Group | Active comparator | Drug: 5mg of Oxycodone every 6 hours as needed for pain |
| NSAID group | Active comparator | Drug: 600mg of Ibuprofen every 6 hours as needed for pain |
| Acetaminophen | Active comparator | Drug: 500mg of Acetaminophen every 6 hours as needed for pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients indicated to undergo primary, unilateral carpal tunnel release or trigger finger release surgery under local anesthesia alone.
- Age eligibility is > 18 years of age.
- Local anesthesia with 1% lidocaine with 1:100,000 epinephrine and Bicarbonate.
Key exclusion criteria (8 listed)
- Bilateral procedures.
- Additional soft tissue or boney procedures performed simultaneously.
- The use of sedation and/or general anesthesia.
- Pediatric patients (age < 18 years).
- Pregnant female patients.
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 |
|---|---|---|
| 5mg of Oxycodone every 6 hours as needed for pain5mg of Oxycodone every 6 hours as needed for pain | Drug | Opioid Group |
| 600mg of Ibuprofen every 6 hours as needed for pain600mg of Ibuprofen every 6 hours as needed for pain | Drug | NSAID group |
| 500mg of Acetaminophen every 6 hours as needed for pain500mg of Acetaminophen every 6 hours as needed for pain | Drug | Acetaminophen |
Primary outcome
Numeric rating Scale for Pain
Time frame: 2 weeks post-op
11-point numeric rating scale (NRS) for pain
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 Jul 2018.
- 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.
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 5mg of Oxycodone every 6 hours as needed for pain, 600mg of Ibuprofen every 6 hours as needed for pain and 500mg of Acetaminophen every 6 hours as needed for pain in people with Post-operative Pain, 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 3 inclusion and 8 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 Jul 2018. 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?
Numeric rating Scale for Pain (time frame: 2 weeks post-op). 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 Jul 2018.