Meloxicam for Postoperative Pain in Mohs Micrographic Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- University of Oklahoma
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- To evaluate the effect of the use of Meloxicam vs SoC on post-operative pain levels in participants undergoing Mohs micrographic surgery.
Study Overview
Brief 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.
- 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
Randomization will occur on which of the 3 groups each patient will be enrolled in, thus the investigators and participants will know which group they are in.
Eligibility Criteria
- Ages
- 18 Years to 110 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Acetaminophen 500mg (Drug)
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.
Intervention: Meloxicam 7.5 mg (Drug)
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.
Intervention: Meloxicam 15 mg (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported