Preoperative Acetaminophen and Carbohydrate Loading

Study Overview
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Brief Summary
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The study's goal is to assess impact of preoperative acetaminophen and oral carbohydrate drinks on pain and functional status experienced by patients undergoing Mohs micrographic surgery for non-melanoma skin cancers. Patients are randomly assigned to receive standard of care or preoperative acetaminophen 1000 mg and Gatorade sports drinks 2 packets before surgery. Patients are then asked to rate their level of pain, anxiety, thirst, hunger, fatigue on a scale of 0-100 on day of surgery before surgery has started, after clearance of skin cancer, and at the end of the visit. Patients are contacted by phone 48 hours after their surgery to assess their maximum level of post-operative pain (rated from 0-100), usage of over the counter or prescribed pain medications, and presence of complications e.g. bleeding, infection, dehiscence. Differences in perioperative functional status and pain medication usage are compared between patients in control and intervention groups.

Official Title
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Impact of Preoperative Acetaminophen and Carbohydrate Loading to on Pain and Functional Status in Patients Undergoing Mohs Micrographic Surgery for Non-melanoma Skin Cancers

Conditions
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Non-melanoma Skin Cancer

Intervention / Treatment
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* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients undergoing Mohs micrographic surgery for non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma) Exclusion Criteria: history of liver transplant, hepatitis, or cirrhosis, those required to be NPO for subsequent closure by other surgical specialties, or those with known allergy to acetaminophen

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The control group will receive usual perioperative care including patient education on diagnosis, treatment and prognosis of skin cancer, encouragement of food and fluid intake prior to and during the surgery as needed, and acetaminophen per patient request. | |
| Experimental: Intervention<br>The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery. | Drug: Acetaminophen<br>* Acetaminophen 1000mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Pain Score | Rated on a pain scale of 0-100. Higher score means worse outcome; lower score means better outcome. | Day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thirst | Rated on a thirst scale of 0-100. Higher score means worse outcome; lower score means better outcome. | Day of surgery | 
| Hunger | Rated on a hunger scale of 0-100. Higher score means worse outcome; lower score means better outcome. | Day of surgery | 
| Anxiety | Rated on n anxiety scale of 0-100. Higher score means worse outcome; lower score means better outcome. | Day of surgery | 
| Fatigue | Rated on a fatigue scale of 0-100. Higher score means worse outcome; lower score means better outcome. | Day of surgery | 
| Number of Participants Using Post-operative Analgesic | Number of participants using over the counter and prescribed non-opioid and opioid pain medications | 48 hours after surgery | 
| Maximum Post-op Pain Score | Rated on a maximum post-op pain scale of 0-100. Higher score means worse outcome; lower score means better outcome. | 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, Mohs micrographic surgery, functional status