Clinical trial NCT03131713
Conditions: Non-melanoma Skin Cancer
Keywords: Mohs micrographic surgery pain functional status
Sponsor: Tufts Medical Center
Start date: 2016-07-01; Completion date: 2017-12-31
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Acetaminophen
Intervention descriptions: intervention 1: Acetaminophen 1000mg

Protocol documents:
Prot_SAP_000.pdf: 
Title: Impact of preoperative acetaminophen and carbohydrate loading on pain and functional 
status in patients undergoing Mohs Micrographic Surgery for non-melanoma skin cancers  
Document date: July 12, 2019 
We conducted a randomized controlled trial to examine the impact of preoperative carbohydrate 
loading and acetaminophen on i) maximum pain level during and after MMS, ii) sensation of 
anxiety, thirst, hunger and fatigue during MMS, and iii) postoperative use of analgesics. All adult 
patients undergoing MMS for keratinocytic skin cancers were eligible for recruitment except for 
those with history of liver transplant, hepatitis, or cirrhosis, or those required to be NPO for 
subsequent closure by other surgical specialties. Patients were assigned to either control or 
intervention group using a random number generator.  
Intervention:  
The control group received usual perioperative care including patient education on diagnosis, 
treatment and prognosis of skin cancer, encouragement of food and fluid intake, and 
acetaminophen per patient request. The intervention group, in addition to usual care, received 
Acetaminophen 1000mg and commercially available carbohydrate drink (50gm in 12 fl. oz.) 
before initiation of MMS.  
Outcome Assessment:  
Primary outcome is maximum pain score during and within 48 hours of surgery as reported by 
patient using a 100mm linear visual analog scale. Patients can place a mark anywhere along a 
100mm continuous line to indicate their level of pain. Pain assessment was performed before 
each Mohs layer and at the end of surgery. Patients were instructed to record their daily 
maximum pain score for post op day 1 and 2 on the linear visual analog scale and return the  


document to the office either in person at the one-week follow-up visit or mailed if unable or 
unwilling to return due to long distance travel.  
Secondary outcomes are i) patient sense of well-being (thirst, hunger, anxiety, and fatigue) at the 
end of surgery, and ii) use of analgesic after surgery. Patients assessed their sense of thirst, 
hunger, anxiety and fatigue before and immediately after surgery using a linear visual analog 
scale, an instrument that is commonly used in clinical trials assessing impact of perioperative 
interventions.6 They were instructed to document use of any analgesics including over-the- 
counter non-opioid or prescribed opioid medications on provided forms. The forms were 
returned in person at one-week follow-up visit or via mail.  
Data Collection:  
The following baseline information were collected from medical records: i) patient age, gender, 
prior history of skin cancer, prior history of MMS, history of anxiety or pain syndromes, and 
food consumption within 2 hours of surgery ii) tumor site, preoperative size, histology, depth of 
invasion, presence of perineural or lymphovascular invasion, and primary vs. recurrent status, iii) 
operative details e.g. case duration (defined as length of time between check-in and check-out), 
number of Mohs layer, final defect size, type of closure, use of oral analgesics during surgery (in 
addition to the preoperative acetaminophen), and iv) post-operative course including presence for 
one-week follow-up visit, complications e.g. bleeding and infection.  
Data Analysis:  
Differences in baseline characteristics between control and intervention groups were analyzed  
using Chi-square for categorical variables, and the t-test for continuous variables. All statistics 
were two-tailed, with a significance level of 0.05.