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NCT Number: NCT06948513

Effect of Over-the-counter Analgesics on Postoperative Pain

In 2011, a randomized controlled trial compared acetaminophen, acetaminophen + ibuprofen, and acetaminophen + codeine for post-operative pain relief after Mohs surgery. In this study, the combination of acetaminophen + ibuprofen was shown to be superior to the other treatment groups at controlling postoperative pain. The study also detailed the timing at which patients experienced pain after cutaneous reconstruction, with peak pain scores occurring at 4 hours post-op for all three groups. Since its publication, the as needed dosage of acetaminophen alternated with ibuprofen has become the standard of care for most patients undergoing cutaneous reconstructive surgery. Additionally, studies from multiple disciplines including cutaneous surgery, emergency medicine, otolaryngology and obstetrics have found that use of non-steroidal anti-inflammatories pose no greater incidence of side effects.

Given that peak pain levels occur approximately four hours after cutaneous reconstruction, likely due to the cessation of lidocaine or other local numbing medications, patients may benefit from additional pain relief during this critical time period. However, it is standard practice to start acetaminophen and ibuprofen only as needed when pain begins. Further, given the short half-life of ibuprofen (2 hours), it is unlikely that this medication taken in the immediate postoperative period would be of benefit at the four hour time mark. Therefore, we theorize that the one-time dosage of a long-acting non-steroidal anti-inflammatory taken upon completion of cutaneous surgery may be superior to the as needed dosing of acetaminophen and ibuprofen.

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Key information

Conditions

Pain Management Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zitelli & Brodland Skin Cancer Center

Clairton, Pennsylvania, 15025, United States

About this study

Upon completion of informed consent, enrolled participants will be randomized to one of two treatment groups.

Group 1 (intervention group): will receive a one-time, mandatory dose of Naproxen sodium 440 mg immediately following completion of cutaneous reconstruction. For a period of 24 hours after surgery, patients will then be instructed to use acetaminophen as needed per manufacturer instructions not to exceed 4 g in a 24 hour period. Patients will not be permitted to use additional nonsteroidal analgesics during the 24 hour period. Patients will be asked to record pain scales in a pain diary at time points 0, 2, 4, 6, 8, 10 and 24 hours after surgery as well as the amount and timing of breakthrough pain medication (acetaminophen). Patients will be contacted the day following their procedure by the Principal Investigator and their responses will be recorded. Upon recording of the patient's pain diary, their enrollment in the study is complete.

Group 2 (control group): will not receive any mandatory dose of postoperative analgesic. As is considered standard of care, these patients will be instructed to alternate use of ibuprofen and acetaminophen on an as needed basis per manufacturer instructions. The dose of acetaminophen is not to exceed 4 g in a 24 hour period. The dose of ibuprofen is not to exceed 1200 mg in a 24 hour period. Patients will be asked to record pain scales in a pain diary at time points 0, 2, 4, 6, 8, 10 and 24 hours after surgery as well as the amount and timing of breakthrough pain medication (acetaminophen or ibuprofen). Patients will be contacted the day following their procedure by the Principal Investigator and their responses will be recorded. Upon recording of the patient's pain diary, their enrollment in the study is complete.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing Mohs micrographic surgery with same-day reconstruction on the head/neck

Exclusion criteria

  • Second intention wound healing Operative site not on head and neck Self-described allergies to acetaminophen or any non-steroidal anti-inflammatory medication Pre-existing pain condition requiring analgesics History of bleeding or clotting disorder Recent history of upper gastrointestinal bleeding or ulcers Advanced liver disease or renal impairment Pregnancy Current use of anticoagulant (examples: aspirin, clopidogrel, warfarin, apixaban)

Treatment and study plan

Naproxen

Drug

Naproxen given immediately post-operatively following Mohs surgery reconstruction

Acetaminophen (Standard of Care)

Drug

Acetaminophen alternated with ibuprofen on an as needed, patient directed basis

Ibuprofen

Drug

Ibuprofen alternated with acetaminophen in a patient directed manner for as needed pain control

Primary outcomes

  1. Patient reported pain score

    Time frame: 10 hours

    Recorded using a visual analog scale and taken at defined time intervals during postoperative period

Secondary outcomes

  1. Additional pain medication used

    Time frame: 10 hours

    Amount of as-needed dosing taken by patients for pain control

Sponsors and collaborators

Lead sponsor

Zitelli & Brodland Skin Cancer Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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