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Postoperative Pain, AcutePhase 4NCT07200544

Meloxicam in Mohs Micrographic Surgery

A Phase 4 study testing Meloxicam 7.5 mg, Meloxicam 15 mg and Acetaminophen 500mg in people with Postoperative Pain, Acute and Skin Cancer, run by University of Oklahoma at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to explore alternative methods of postoperative pain control in Mohs micrographic surgery. The main aims are: To provide more information to the Mohs surgery community regarding postoperative pain control. Read more about this study

Who is it for?
Ages 18 to 110 years
Conditions the study is for
Postoperative Pain, Acute, Skin Cancer
What is being tested?
Meloxicam 7.5 mg, Meloxicam 15 mg and Acetaminophen 500mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
15 Oct 2025to 2 Aug 2026
Phase
Phase 4
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 18 to 110 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All adult patients who consents to the study and are undergoing Mohs micrographic surgery at the University of Oklahoma.

Who cannot join

  • Women who are pregnant, suspected to be pregnant, or planning to become pregnant during the study period will be excluded from participation.
  • Chronic liver disease (chronic hepatitis, acute hepatitis, cirrhosis, NASH, NAFLD, alcoholic liver disease, hemochromatosis, Wilson's disease)
  • Chronic kidney disease stage III or greater,
  • Aspirin-sensitive asthma
  • History of chronic NSAID use
  • Patients vulnerable to drug interactions
Show all 9Show fewer
  • GI bleeds
  • Peptic ulcers
  • Non-English speakers

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chase Pitchford, MD contact

405-271-6110

chase-pitchford@ouhsc.edu

Landon Hendrickson, MD contact

405-271-6110

Landon-Hendrickson@ou.edu

United States1 site, 1 recruiting
  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Chase Pitchford, 405-271-6110, Chase-Pitchford@ouhsc.edu

    Lindsey Collins, 405-271-6110, Lindsey-Collins@ouhsc.edu

    Recruiting

Other trials in United States

About this study

Official title: Meloxicam for Postoperative Pain in Mohs Micrographic Surgery

The goal of this clinical trial is to explore alternative methods of postoperative pain control in Mohs micrographic surgery. The main aims are:

  • To provide more information to the Mohs surgery community regarding postoperative pain control.
  • Reducing pain improves the overall comfort and well-being of patients, leading to a better post-operative experience.
  • To provide patients with an alternative and potentially superior NSAID for pain control (compared to standard-of-care ibuprofen).
Read more

Researchers will compare 1) a single of dose Meloxicam 7.5 mg, followed by acetaminophen 500 mg; 2) a single dose of Meloxicam 15 mg, followed by acetaminophen 500 mg; 3) a single dose of acetaminophen 500 mg, followed by alternating ibuprofen 200 mg and acetaminophen 500 mg to see which better moderate pain control and patient satisfaction.

Participants will be asked to complete pain and patient satisfaction surveys.

Read the detailed description

Mohs micrographic surgery (MMS) is a microscope-guided tissue-sparing surgical procedure for the removal of certain skin cancers, in which 100% of the surgical margin is examined. It is the gold-standard for the treatment of high-risk and aggressive nonmelanoma skin cancer. It is an incredibly safe procedure and postoperative complications are uncommon, occurring in only 0.72% of cases. It is the most cost-effective form of skin cancer removal and has higher cure rates when compared to standard excision.

Despite the safety and tolerability of the procedure, postoperative patient concerns have been assessed in the literature with pain being the most common. Using classical pain assessment models, pain is often assessed by the patient as mild to moderate. On average pain is at its worst on POD0 of surgery, with one study finding peak pain scores between 2PM to 10PM on POD02. Studies have often demonstrated that the most painful anatomical sites are the nose, ear, forehead, scalp, periorbital region, and lip with the scalp being associated with the most postoperative pain. Those who undergo linear closure or second intent healing report significantly less pain postoperatively than those who undergo flaps and full-thickness-skin grafts with age (<66 years), number of lesions, and consumption of narcotics for pain relief.

Specific Aims, long-term objectives, research accomplishments:

This study will hopefully provide more information to the Mohs surgery community regarding postoperative pain control.

Reducing pain improves the overall comfort and well-being of patients, leading to a better post-operative experience.

To provide patients with an alternative and potentially superior NSAID for pain control (compared to standard-of-care ibuprofen).

To provide a pain medication option that has a longer half-life with a reduction in patient breakthrough pain and the necessity of taking more frequent medication Discovering non-opioid pain control methods can help decrease the reliance on opioids, reducing the risk of addiction and other opioid-related side effects.

Managing pain effectively can help prevent post-operative anxiety and depression, contributing to better mental health outcomes Managing pain effectively can contribute to better Mohs surgery patient outcomes Advances in pain management can contribute to more personalized approaches, tailoring pain control strategies to individual patient needs

Background and Significance:

Standard of care postoperative pain control in Mohs micrographic surgery is alternating Tylenol and ibuprofen as directed on the manufactures label. Randomized controlled trials on postoperative pain in MMS. Upon literature review there have not been any studies in MMS using meloxicam as a postoperative pain alternative to standard of care. To date, acetaminophen and codeine, celecoxib, pregabalin, naproxen, aspirin, and other opioid prescriptions have been used for postoperative pain5-7

Meloxicam is approved for the treatment of osteoarthritis in the United States. At low doses it is COX-2 preferential, inhibiting prostanoid synthesis in inflammatory cells. In clinical trials, meloxicam was found to be as effective as naproxen, piroxicam, and diclofenac with few GI symptoms and lower incidence of perforation, obstruction and bleeding8. Compared to the medications listed above, oral meloxicam has the longest half-life at around 20 hours8. Given its long half-life, the investigators hypothesize that meloxicam will result in pain control over the postoperative time periods when pain is at its worst (POD0 and POD1). This will decrease the need for adding other pain control medicines, decrease break through pain, and increase patient satisfaction with postoperative pain control. Postoperative pain in MMS has been explored for decades and this pain-control alternative can be used as a useful tool for the surgeon.

Being tested
Meloxicam 7.5 mg, Meloxicam 15 mg, Acetaminophen 500mg
Keywords
Mohs micrographic surgery, Postoperative Pain, NSAID, Acetaminophen
Medical subject headings
Pain, Postoperative, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meloxicam 7.5 mgDrug

    This intervention is the mandatory oral Meloxicam 7.5mg dose after Mohs closure.

  • Meloxicam 15 mgDrug

    This intervention is the mandatory oral Meloxicam 15mg dose after Mohs closure.

  • Acetaminophen 500mgDrug

    This randomized control group will take a mandatory one-time dose of 500 mg acetaminophen with alternating 200 mg ibuprofen and 500 mg acetaminophen (standard of care) every 3 hours for pain.

Study groups in NCT07200544
Study groupRoleWhat they receive
Standard of Care (Acetaminophen/Ibuprofen)Active comparatorThis randomized control group will take a mandatory one-time dose of 500 mg acetaminophen with alternating 200 mg ibuprofen and 500 mg acetaminophen (standard of care) every 3 hours for pain.
Receives: Drug: Acetaminophen 500mg
Meloxicam 7.5 mgExperimentalThis randomly assigned experimental group will take a mandatory one-time dose of oral Meloxicam 7.5 mg with as-needed acetaminophen 500 mg every 3 hours. Administration of Meloxicam will be upon completion of Mohs closure.
Receives: Drug: Meloxicam 7.5 mg
Meloxicam 15 mgExperimentalThis randomly assigned experimental group will take a mandatory one-time dose of oral Meloxicam 15 mg with as-needed acetaminophen 500 mg every 3 hours. Administration of Meloxicam will be upon completion of Mohs closure.
Receives: Drug: Meloxicam 15 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the effect of the use of Meloxicam vs SoC on post-operative pain levels in participants undergoing Mohs micrographic surgery.

    Pain levels at specified times post-operation (POD 0 and POD 1) will be compared among the three treatment groups. This will be collected via the Numeric Pain Scale, a 0-10 scale using descriptives faces to assess pain by the patient.

    Measured: From enrollment to suture removal, wound check or flap takedown (7-21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2025
  2. Study start15 Oct 2025
  3. Primary completion2 Jun 2026 (estimated)
  4. Study completion2 Aug 2026 (estimated)

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are assigned to one of three groups, and each group receives a different intervention.
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07200544
Sponsor's protocol ID
18006
Status last verified
Dec 2025
First submitted
21 Jan 2025
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Limthongkul B, Samie F, Humphreys TR. Assessment of postoperative pain after Mohs micrographic surgery. Dermatol Surg. 2013 Jun;39(6):857-63. doi: 10.1111/dsu.12166. Epub 2013 Mar 6.

    PubMed 23464845
  • Benzon HT. Practical management of pain. 2014;

  • Evans T, Nicholas TA, Sutton AV, Wysong A. How We Do It: Postoperative Pain Control in Mohs Micrographic Surgery. Dermatol Surg. 2021 Feb 1;47(2):280-282. doi: 10.1097/DSS.0000000000002279. No abstract available.

    PubMed 31809346
  • Sniezek PJ, Brodland DG, Zitelli JA. A randomized controlled trial comparing acetaminophen, acetaminophen and ibuprofen, and acetaminophen and codeine for postoperative pain relief after Mohs surgery and cutaneous reconstruction. Dermatol Surg. 2011 Jul;37(7):1007-13. doi: 10.1111/j.1524-4725.2011.02022.x. Epub 2011 May 11.

    PubMed 21561527
  • Firoz BF, Goldberg LH, Arnon O, Mamelak AJ. An analysis of pain and analgesia after Mohs micrographic surgery. J Am Acad Dermatol. 2010 Jul;63(1):79-86. doi: 10.1016/j.jaad.2009.10.049.

    PubMed 20542176
  • Saco M, Golda N. Optimal timing of postoperative pharmacologic pain control in Mohs micrographic surgery: A prospective cohort study. J Am Acad Dermatol. 2020 Feb;82(2):495-497. doi: 10.1016/j.jaad.2019.07.077. Epub 2019 Jul 30. No abstract available.

    PubMed 31374303
  • Alam M, Ibrahim O, Nodzenski M, Strasswimmer JM, Jiang SI, Cohen JL, Albano BJ, Batra P, Behshad R, Benedetto AV, Chan CS, Chilukuri S, Crocker C, Crystal HW, Dhir A, Faulconer VA, Goldberg LH, Goodman C, Greenbaum SS, Hale EK, Hanke CW, Hruza GJ, Jacobson L, Jones J, Kimyai-Asadi A, Kouba D, Lahti J, Macias K, Miller SJ, Monk E, Nguyen TH, Oganesyan G, Pennie M, Pontius K, Posten W, Reichel JL, Rohrer TE, Rooney JA, Tran HT, Poon E, Bolotin D, Dubina M, Pace N, Kim N, Disphanurat W, Kathawalla U, Kakar R, West DP, Veledar E, Yoo S. Adverse events associated with mohs micrographic surgery: multicenter prospective cohort study of 20,821 cases at 23 centers. JAMA Dermatol. 2013 Dec;149(12):1378-85. doi: 10.1001/jamadermatol.2013.6255.

    PubMed 24080866

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Meloxicam 7.5 mg, Meloxicam 15 mg and Acetaminophen 500mg in people with Postoperative Pain, Acute and Skin Cancer, run by University of Oklahoma 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 9 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: looking for participants now, as of the sponsor's last update on 15 Dec 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 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Chase Pitchford, MD (405-271-6110, chase-pitchford@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the effect of the use of Meloxicam vs SoC on post-operative pain levels in participants undergoing Mohs micrographic surgery. (time frame: From enrollment to suture removal, wound check or flap takedown (7-21 days)). 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 NCT07200544, which also lists 7 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 15 Dec 2025; AzTrials last refreshed its copy on 29 Oct 2026.

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