The ongoing opioid epidemic is a public health crisis, and surgical patients are particularly vulnerable to opioid-dependency and related risks. Emerging data suggest that caffeine may reduce pain after surgery. Thus, the purpose of this study is to test whether caffeine reduces pain and opioid requirements after surgery. The investigators will also test whether caffeine improves mood and brain function (e.g., learning, memory) after surgery.
Opioid-related deaths have quadrupled in the last 20 years, and nearly half of these deaths currently involve prescription opioids. Surgical patients often experience moderate-to-severe pain is common after major surgery, and surgery is associated with a 14-fold increased risk of opioid dependency compared to non-surgical controls, even after minor surgery. Furthermore, mood disorders (e.g., depression) are independently associated with persistent opioid use postoperatively, and signs of postoperative depression are common after major surgery. Thus, given these risk factors, surgical patients are at particularly high risk for opioid dependency postoperatively. Interventions that (1) reduce opioid burden, and (2) improve mood and neuropsychological function may mitigate the risk of postoperative opioid dependency. Preliminary laboratory and clinical findings demonstrate that caffeine may reduce pain after surgery, which may translate to lower opioid requirements. The study tests the hypothesis that intraoperative caffeine administration will improve opioid consumption, pain, and neuropsychological recovery in patients undergoing surgery. Through validated assessment measures, the research team will study the effects of caffeine in relation to postoperative opioid requirements, pain, and neuropsychological (e.g., cognition, depression, anxiety) trajectory after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
71
Prepared intravenous piggyback solutions of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants.
Prepared intravenous piggyback solutions of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants.
Michigan Medicine
Ann Arbor, Michigan, United States
Cumulative Opioid Consumption: Postoperative Opioid Consumption, Oral Morphine Equivalents (mg)
Postoperative opioid consumption, oral morphine equivalents (mg)
Time frame: through postoperative day 3
Acute Pain (Patient-reported) as Assessed by Visual Analogue Scale
Visual Analogue Scale (mm, 0-100, 0 = no pain, 100 = worst pain imaginable)
Time frame: Data gathered from postoperative day 0-3. Final results were based on all values combined over this time period, per protocol.
Acute Pain (Observer-reported) as Assessed by Behavioral Pain Scale
Behavioral Pain Scale, on a scale ranging from 3 to 12 when 3 is no pain and 12 is maximum pain
Time frame: Data gathered from postoperative day 0-3. Final results were based on all values combined over this time period, per protocol.
Time Until Anesthetic Emergence
Time from surgical dressing on to anesthetic emergence (min)
Time frame: Duration of time from surgical dressing completion to anesthetic emergence (min); generally expected to be between 10 and 60 minutes
Number of Participants With Depression as Assessed by the Hospitalized Anxiety and Depression Scale (HADS-D)
Number (n) of participants with positive screens (score ≥8) using the Hospitalized Anxiety and Depression Scale (HADS-D) (n, 0-21, 0 = normal, 21 = presence of severe depression symptoms)
Time frame: baseline through postoperative day 3
Number of Participants With Anxiety as Assessed by the Hospitalized Anxiety and Depression Scale (HADS-A)
Number (n) of participants with positive screens (score ≥8) using the Hospitalized Anxiety and Depression Scale (HADS-A) (n, 0-21, 0 = normal, 21 = presence of severe anxiety symptoms)
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Time frame: baseline through postoperative day 3
Cognitive Function as Assessed by Trail Making Test
Trail Making Test scores (seconds, 10-300,10 = fastest reported completion, 300 = maximum time allowed for completion). The change was calculated from the value at post anesthesia minus value at baseline. Higher values are considered to be worse outcomes.
Time frame: morning of surgery baseline compared to postanesthesia care unit. Postanesthesia care unit measurement approximately 60 minutes after end of surgery
Positive Affect as Assessed by PANAS (Positive and Negative Affect Schedule)
Positive Affect Score (n, 10-50, 10 = least positive affect, 50 = most positive affect) via PANAS (Positive and Negative Affect Schedule)
Time frame: postoperative day 3
Negative Affect as Assessed by PANAS (Positive and Negative Affect Schedule)
Negative Affect Score (n, 10-50, 10 = least negative affect, 50 = most negative affect) via PANAS (Positive and Negative Affect Schedule)
Time frame: postoperative day 3
Percentage of Delirious Patients Per Group
Number (n) of participants who has experienced at least one episode of delirium by the postoperative day 3 time point, as determined by daily Confusion Assessment Method (CAM).
Time frame: By afternoon of postoperative day (POD) 3