Pain ManagementWALANTNCT06917118
Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial
A study testing Oxycodone 5mg taken first, Acetaminophen and Naproxen Tablets, 500 mg in people with Pain Management, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial summary
The main objective of the study is to measure the efficacy of a multimodal postoperative pain regimen consisting of oral acetaminophen and naproxen compared to a traditional opioid-only pain regimen following elective wide awake local anesthesia no tourniquet (WALANT) hand surgery in a Hispanic population. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Pain Management
- What is being tested?
- Oxycodone 5mg taken first, Acetaminophen and Naproxen Tablets, 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 1 May 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 21-70 years of age undergoing outpatient hand surgery
- Patients undergoing surgery with WALANT technique
- Patients who provide written informed consent
Who cannot join
- Patients aged 20 and younger, or 71 and older
- Patient with chronic pain requiring opioid use
- Pregnant patients
- Patients who do not self-identify as Hispanic
- Patients with known allergy to the medication
- Patients with contraindications for the prescribed medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Puerto Rico1 site
Oncological Hospital
San Juan, PR, 00935
Jose I Acosta Julbe, MD, +1 7873794119, jose.acosta14@upr.edu
About this study
The main objective of the study is to measure the efficacy of a multimodal postoperative pain regimen consisting of oral acetaminophen and naproxen compared to a traditional opioid-only pain regimen following elective wide awake local anesthesia no tourniquet (WALANT) hand surgery in a Hispanic population. The study is a randomized control trial comparing the clinical outcomes of patients undergoing elective WALANT hand surgery performed by a board-certified, fellowship-trained orthopedic hand surgeon (Dr. Christian A. Foy).
The study groups are:
Read more
- Control group: standard pain control with opioids
- Experimental group: multimodal non-opioid pain control
Study Outcomes are:
- VAS pain scores (7 days),
- Total opioid usage
- Patient satisfaction
- Adverse events
We hypothesize that patients receiving multimodal pain regimens will report lower opioid use, lower pain scores, and greater satisfaction than patients receiving traditional opioid-only pain management.
Read the detailed description
The main objective of the study is to measure the efficacy of a multimodal postoperative pain regimen consisting of oral acetaminophen and naproxen compared to a traditional opioid-only pain regimen following elective wide awake local anesthesia no tourniquet (WALANT) hand surgery in a Hispanic population. The study is a single-blind, single-center randomized control trial comparing the clinical outcomes of patients undergoing elective WALANT hand surgery performed by a board-certified, fellowship-trained orthopedic hand surgeon (Dr. Christian A. Foy). Patients will be consecutively recruited at the center and randomized in a 1:1 ratio into the control and experimental groups. The control group will receive the standard of care for postoperative pain: 10 pills of 5mg oxycodone Q4hrs as needed. The experimental group will receive 30 pills of 500mg acetaminophen Q4hrs and 30 pills of 500mg naproxen Q4hrs until pain resolves or treatment is completed. The experimental group will also receive 5 tablets of 5mg oxycodone to take Q4hrs as needed for breakthrough pain. Postoperatively, daily pain Visual Analog Scale (VAS) scores, total opioid usage, patient satisfaction, and adverse events will be recorded. We hypothesize that patients receiving multimodal pain regimens will report lower opioid use, lower pain scores, and greater satisfaction than patients receiving traditional opioid-only pain management.
- Conditions
- Pain Management
- Being tested
- Oxycodone 5mg taken first, Acetaminophen, Naproxen Tablets, 500 mg, OxyCODONE 5 mg Oral Tablet
- Keywords
- WALANT, Multimodal analgesia, Nonopioid pain management, VAS pain scores
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone 5mg taken firstDrug
10 pills of 5mg oxycodone Q4hrs as needed
AcetaminophenDrug
30 pills of 500mg acetaminophen Q4hrs
Naproxen Tablets, 500 mgDrug
30 pills of 500mg naproxen Q4hrs
OxyCODONE 5 mg Oral TabletDrug
Only used for breakthrough pain
| Study group | Role | What they receive |
|---|---|---|
| Standard Postoperative opioid analgesia | Active comparator | 10 pills of 5mg oxycodone Q4hrs as needed Receives: Drug: Oxycodone 5mg taken first |
| Postoperative Opioid-sparing Multimodal analgesia | Experimental | 30 pills of 500mg acetaminophen Q4hrs and 30 pills of 500mg naproxen Q4hrs. Will also receive 5 tablets of 5mg oxycodone to take Q4hrs as needed for breakthrough pain Receives: Drug: Acetaminophen; Drug: Naproxen Tablets, 500 mg; Drug: OxyCODONE 5 mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Pain Scores
VAS pain scores will be assessed using a patient- completed VAS pain questionnaire until 7 days post-op. Patients will take the questionnaire home and report pain scores in the morning and in the afternoon every day for a week.
Measured: From enrollment to the end of treatment at 7 days
Patient Satisfaction
Patient satisfaction will be assessed using the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Measured: From enrollment to the end of treatment at 7 days
Total Opioid Usage
Will be reported in as morphine milligram equivalents (MMEs)
Measured: From enrollment to the end of treatment at 7 days
Secondary outcomes (3)
Breakthrough Pain
Breakthrough pain will be reported as a binary outcome (Y/N)
Measured: From enrollment to the end of treatment at 7 days
Length of Treatment
Patients will be asked to report the number of days in which they used the provided pain control treatment
Measured: From enrollment to the end of treatment at 7 days
Indication for WALANT surgery
We will report the indication for treatment for each patient to include in the final analysis
Measured: From enrollment to the end of treatment at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Deliz, University of Puerto Rico
- Investigators
- Christian A. Foy, MD, Principal investigator, University of Puerto Rico Medical Sciences Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917118
- Sponsor's protocol ID
- 2501339638
- Acronym
- WALANT
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will only be used internally by the study PI and primary investigators.
Publications
Abdullah S, Ahmad AA, Lalonde D. Wide Awake Local Anesthesia No Tourniquet Forearm Triple Tendon Transfer in Radial Nerve Palsy. Plast Reconstr Surg Glob Open. 2020 Aug 11;8(8):e3023. doi: 10.1097/GOX.0000000000003023. eCollection 2020 Aug.
PubMed 32983779Burn MB, Shapiro LM, Eppler SL, Behal R, Kamal RN. Clinical Care Redesign to Improve Value for Trigger Finger Release: A Before-and-After Quality Improvement Study. Hand (N Y). 2021 Sep;16(5):624-631. doi: 10.1177/1558944719884661. Epub 2019 Nov 5.
PubMed 31690136Lalonde D, Bell M, Benoit P, Sparkes G, Denkler K, Chang P. A multicenter prospective study of 3,110 consecutive cases of elective epinephrine use in the fingers and hand: the Dalhousie Project clinical phase. J Hand Surg Am. 2005 Sep;30(5):1061-7. doi: 10.1016/j.jhsa.2005.05.006.
PubMed 16182068Chowdhry S, Seidenstricker L, Cooney DS, Hazani R, Wilhelmi BJ. Do not use epinephrine in digital blocks: myth or truth? Part II. A retrospective review of 1111 cases. Plast Reconstr Surg. 2010 Dec;126(6):2031-2034. doi: 10.1097/PRS.0b013e3181f44486.
PubMed 20697319Sawhney A, Thacoor A, Nagra R, Geoghegan L, Akhavani M. Wide Awake Local Anesthetic No Tourniquet in Hand and Wrist Surgery: Current Concepts, Indications, and Considerations. Plast Reconstr Surg Glob Open. 2024 Jan 22;12(1):e5526. doi: 10.1097/GOX.0000000000005526. eCollection 2024 Jan.
PubMed 38260757Deutsch CJ, Jones K, Dassayanake S, Milroy C. Concern about ischaemia drives a persistent and generation-spanning aversion to adrenaline in digital anaesthesia. JPRAS Open. 2021 Jan 26;28:61-63. doi: 10.1016/j.jpra.2021.01.006. eCollection 2021 Jun. No abstract available.
PubMed 33732855Fillingham YA, Hannon CP, Erens GA; AAHKS Anesthesia & Analgesia Clinical Practice Guideline Workgroup; Hamilton WG, Della Valle CJ. Acetaminophen in Total Joint Arthroplasty: The Clinical Practice Guidelines of the American Association of Hip and Knee Surgeons, American Society of Regional Anesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, Hip Society, and Knee Society. J Arthroplasty. 2020 Oct;35(10):2697-2699. doi: 10.1016/j.arth.2020.05.030. Epub 2020 May 26. No abstract available.
PubMed 32571591Padilla JA, Gabor JA, Schwarzkopf R, Davidovitch RI. A Novel Opioid-Sparing Pain Management Protocol Following Total Hip Arthroplasty: Effects on Opioid Consumption, Pain Severity, and Patient-Reported Outcomes. J Arthroplasty. 2019 Nov;34(11):2669-2675. doi: 10.1016/j.arth.2019.06.038. Epub 2019 Jun 26.
PubMed 31311667Gimbel JS, Brugger A, Zhao W, Verburg KM, Geis GS. Efficacy and tolerability of celecoxib versus hydrocodone/acetaminophen in the treatment of pain after ambulatory orthopedic surgery in adults. Clin Ther. 2001 Feb;23(2):228-41. doi: 10.1016/s0149-2918(01)80005-9.
PubMed 11293556Thompson KA, Klein D, Alaia MJ, Strauss EJ, Jazrawi LM, Campbell KA. Opioid Use Is Reduced in Patients Treated with NSAIDs After Arthroscopic Bankart Repair: A Randomized Controlled Study. Arthrosc Sports Med Rehabil. 2020 Dec 27;3(1):e15-e22. doi: 10.1016/j.asmr.2020.08.003. eCollection 2021 Feb.
PubMed 33615243Hess-Arcelay H, Claudio-Marcano A, Torres-Lugo NJ, Deliz-Jimenez D, Acosta-Julbe J, Hernandez G, Deliz-Jimenez D, Monge G, Ramirez N, Lojo-Sojo L. Opioid-Sparing Nonsteroid Anti-inflammatory Drugs Protocol in Patients Undergoing Intramedullary Nailing of Tibial Shaft Fractures: A Randomized Control Trial. J Am Acad Orthop Surg. 2024 Jun 15;32(12):e596-e604. doi: 10.5435/JAAOS-D-23-01014. Epub 2024 Apr 4.
PubMed 38579315American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
PubMed 22227789Chung F, Ritchie E, Su J. Postoperative pain in ambulatory surgery. Anesth Analg. 1997 Oct;85(4):808-16. doi: 10.1097/00000539-199710000-00017.
PubMed 9322460Pasero C, McCaffery M. Orthopaedic postoperative pain management. J Perianesth Nurs. 2007 Jun;22(3):160-72; quiz 172-3. doi: 10.1016/j.jopan.2007.02.004.
PubMed 17543801Trasolini NA, McKnight BM, Dorr LD. The Opioid Crisis and the Orthopedic Surgeon. J Arthroplasty. 2018 Nov;33(11):3379-3382.e1. doi: 10.1016/j.arth.2018.07.002. Epub 2018 Jul 11.
PubMed 30075877
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06917118
- Acronym / sponsor ID
- WALANT / 2501339638
- Conditions
- Pain Management
- Keywords
- WALANT, Multimodal analgesia, Nonopioid pain management, VAS pain scores
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 8 Apr 2025 (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 main objective of the study is to measure the efficacy of a multimodal postoperative pain regimen consisting of oral acetaminophen and naproxen compared to a traditional opioid-only pain regimen following elective wide awake local anesthesia no tourniquet (WALANT) hand surgery in a Hispanic population. The study is a randomized control trial comparing the clinical outcomes of patients undergoing elective WALANT hand surgery performed by a board-certified, fellowship-trained orthopedic hand surgeon (Dr. Christian A. Foy).
The study groups are:
- Control group: standard pain control with opioids
- Experimental group: multimodal non-opioid pain control
Study Outcomes are:
- VAS pain scores (7 days),
- Total opioid usage
- Patient satisfaction
- Adverse events
We hypothesize that patients receiving multimodal pain regimens will report lower opioid use, lower pain scores, and greater satisfaction than patients receiving traditional opioid-only pain management.
Detailed description
The main objective of the study is to measure the efficacy of a multimodal postoperative pain regimen consisting of oral acetaminophen and naproxen compared to a traditional opioid-only pain regimen following elective wide awake local anesthesia no tourniquet (WALANT) hand surgery in a Hispanic population. The study is a single-blind, single-center randomized control trial comparing the clinical outcomes of patients undergoing elective WALANT hand surgery performed by a board-certified, fellowship-trained orthopedic hand surgeon (Dr. Christian A. Foy). Patients will be consecutively recruited at the center and randomized in a 1:1 ratio into the control and experimental groups. The control group will receive the standard of care for postoperative pain: 10 pills of 5mg oxycodone Q4hrs as needed. The experimental group will receive 30 pills of 500mg acetaminophen Q4hrs and 30 pills of 500mg naproxen Q4hrs until pain resolves or treatment is completed. The experimental group will also receive 5 tablets of 5mg oxycodone to take Q4hrs as needed for breakthrough pain. Postoperatively, daily pain Visual Analog Scale (VAS) scores, total opioid usage, patient satisfaction, and adverse events will be recorded. We hypothesize that patients receiving multimodal pain regimens will report lower opioid use, lower pain scores, and greater satisfaction than patients receiving traditional opioid-only pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Postoperative opioid analgesia | Active comparator | Drug: Oxycodone 5mg taken first10 pills of 5mg oxycodone Q4hrs as needed |
| Postoperative Opioid-sparing Multimodal analgesia | Experimental | Drug: Acetaminophen, Drug: Naproxen Tablets, 500 mg, Drug: OxyCODONE 5 mg Oral Tablet30 pills of 500mg acetaminophen Q4hrs and 30 pills of 500mg naproxen Q4hrs. Will also receive 5 tablets of 5mg oxycodone to take Q4hrs as needed for breakthrough pain |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 21-70 years of age undergoing outpatient hand surgery
- Patients undergoing surgery with WALANT technique
- Patients who provide written informed consent
Key exclusion criteria (6 listed)
- Patients aged 20 and younger, or 71 and older
- Patient with chronic pain requiring opioid use
- Pregnant patients
- Patients who do not self-identify as Hispanic
- Patients with known allergy to the medication
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 |
|---|---|---|
| Oxycodone 5mg taken first10 pills of 5mg oxycodone Q4hrs as needed | Drug | Standard Postoperative opioid analgesia |
| Acetaminophen30 pills of 500mg acetaminophen Q4hrs | Drug | Postoperative Opioid-sparing Multimodal analgesia |
| Naproxen Tablets, 500 mg30 pills of 500mg naproxen Q4hrs | Drug | Postoperative Opioid-sparing Multimodal analgesia |
| OxyCODONE 5 mg Oral TabletOnly used for breakthrough pain | Drug | Postoperative Opioid-sparing Multimodal analgesia |
Primary outcome
VAS Pain Scores
Time frame: From enrollment to the end of treatment at 7 days
VAS pain scores will be assessed using a patient- completed VAS pain questionnaire until 7 days post-op. Patients will take the questionnaire home and report pain scores in the morning and in the afternoon every day for a week.
Patient Satisfaction
Time frame: From enrollment to the end of treatment at 7 days
Patient satisfaction will be assessed using the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Total Opioid Usage
Time frame: From enrollment to the end of treatment at 7 days
Will be reported in as morphine milligram equivalents (MMEs)
3 secondary outcomes
Breakthrough Pain
Time frame: From enrollment to the end of treatment at 7 days
Length of Treatment
Time frame: From enrollment to the end of treatment at 7 days
Indication for WALANT surgery
Time frame: From enrollment to the end of treatment at 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Background: PubMed 32983779Abdullah S, Ahmad AA, Lalonde D. Wide Awake Local Anesthesia No Tourniquet Forearm Triple Tendon Transfer in Radial Nerve Palsy. Plast Reconstr Surg Glob Open. 2020 Aug 11;8(8):e3023. doi: 10.1097/GOX.0000000000003023. eCollection 2020 Aug.
- Background: PubMed 31690136Burn MB, Shapiro LM, Eppler SL, Behal R, Kamal RN. Clinical Care Redesign to Improve Value for Trigger Finger Release: A Before-and-After Quality Improvement Study. Hand (N Y). 2021 Sep;16(5):624-631. doi: 10.1177/1558944719884661. Epub 2019 Nov 5.
- Background: PubMed 16182068Lalonde D, Bell M, Benoit P, Sparkes G, Denkler K, Chang P. A multicenter prospective study of 3,110 consecutive cases of elective epinephrine use in the fingers and hand: the Dalhousie Project clinical phase. J Hand Surg Am. 2005 Sep;30(5):1061-7. doi: 10.1016/j.jhsa.2005.05.006.
- Background: PubMed 20697319Chowdhry S, Seidenstricker L, Cooney DS, Hazani R, Wilhelmi BJ. Do not use epinephrine in digital blocks: myth or truth? Part II. A retrospective review of 1111 cases. Plast Reconstr Surg. 2010 Dec;126(6):2031-2034. doi: 10.1097/PRS.0b013e3181f44486.
- Background: PubMed 38260757Sawhney A, Thacoor A, Nagra R, Geoghegan L, Akhavani M. Wide Awake Local Anesthetic No Tourniquet in Hand and Wrist Surgery: Current Concepts, Indications, and Considerations. Plast Reconstr Surg Glob Open. 2024 Jan 22;12(1):e5526. doi: 10.1097/GOX.0000000000005526. eCollection 2024 Jan.
- Background: PubMed 33732855Deutsch CJ, Jones K, Dassayanake S, Milroy C. Concern about ischaemia drives a persistent and generation-spanning aversion to adrenaline in digital anaesthesia. JPRAS Open. 2021 Jan 26;28:61-63. doi: 10.1016/j.jpra.2021.01.006. eCollection 2021 Jun. No abstract available.
- Background: PubMed 32571591Fillingham YA, Hannon CP, Erens GA; AAHKS Anesthesia & Analgesia Clinical Practice Guideline Workgroup; Hamilton WG, Della Valle CJ. Acetaminophen in Total Joint Arthroplasty: The Clinical Practice Guidelines of the American Association of Hip and Knee Surgeons, American Society of Regional Anesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, Hip Society, and Knee Society. J Arthroplasty. 2020 Oct;35(10):2697-2699. doi: 10.1016/j.arth.2020.05.030. Epub 2020 May 26. No abstract available.
- Background: PubMed 31311667Padilla JA, Gabor JA, Schwarzkopf R, Davidovitch RI. A Novel Opioid-Sparing Pain Management Protocol Following Total Hip Arthroplasty: Effects on Opioid Consumption, Pain Severity, and Patient-Reported Outcomes. J Arthroplasty. 2019 Nov;34(11):2669-2675. doi: 10.1016/j.arth.2019.06.038. Epub 2019 Jun 26.
- Background: PubMed 11293556Gimbel JS, Brugger A, Zhao W, Verburg KM, Geis GS. Efficacy and tolerability of celecoxib versus hydrocodone/acetaminophen in the treatment of pain after ambulatory orthopedic surgery in adults. Clin Ther. 2001 Feb;23(2):228-41. doi: 10.1016/s0149-2918(01)80005-9.
- Background: PubMed 33615243Thompson KA, Klein D, Alaia MJ, Strauss EJ, Jazrawi LM, Campbell KA. Opioid Use Is Reduced in Patients Treated with NSAIDs After Arthroscopic Bankart Repair: A Randomized Controlled Study. Arthrosc Sports Med Rehabil. 2020 Dec 27;3(1):e15-e22. doi: 10.1016/j.asmr.2020.08.003. eCollection 2021 Feb.
- Background: PubMed 38579315Hess-Arcelay H, Claudio-Marcano A, Torres-Lugo NJ, Deliz-Jimenez D, Acosta-Julbe J, Hernandez G, Deliz-Jimenez D, Monge G, Ramirez N, Lojo-Sojo L. Opioid-Sparing Nonsteroid Anti-inflammatory Drugs Protocol in Patients Undergoing Intramedullary Nailing of Tibial Shaft Fractures: A Randomized Control Trial. J Am Acad Orthop Surg. 2024 Jun 15;32(12):e596-e604. doi: 10.5435/JAAOS-D-23-01014. Epub 2024 Apr 4.
- Background: PubMed 22227789American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will only be used internally by the study PI and primary investigators.
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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.
Christian A. Foy, MD principal investigator
University of Puerto Rico Medical Sciences Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxycodone 5mg taken first, Acetaminophen and Naproxen Tablets, 500 mg in people with Pain Management, run by University of Puerto Rico at 1 site in Puerto Rico.
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 6 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: opening soon, as of the sponsor's last update on 8 Apr 2025. 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 Puerto Rico. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose I Acosta Julbe, MD (+1 7873794119, jose.acosta14@upr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS Pain Scores (time frame: From enrollment to the end of treatment at 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06917118, which also lists 20 linked publications.
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 8 Apr 2025.