Meloxicam in Mohs Micrographic Surgery

December 9, 2025 updated by: University of Oklahoma

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).

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lindsey Collins, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • GI bleeds
  • Peptic ulcers
  • Non-English speakers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care (Acetaminophen/Ibuprofen)
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.
Drug: Acetaminophen 500mg
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.
Experimental: Meloxicam 7.5 mg
This 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.
Drug: Meloxicam 7.5 mg
This intervention is the mandatory oral Meloxicam 7.5mg dose after Mohs closure.
Experimental: Meloxicam 15 mg
This 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.
Drug: Meloxicam 15 mg
This intervention is the mandatory oral Meloxicam 15mg dose after Mohs closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
From enrollment to suture removal, wound check or flap takedown (7-21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Lindsey Collins, MD, University of Oklahoma, Department of Dermatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2025

Primary Completion (Estimated)

June 2, 2026

Study Completion (Estimated)

August 2, 2026

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

September 26, 2025

First Posted (Estimated)

October 1, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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