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Testing the Effects of Removing Gabapentin from Standard Pre-Surgical Orders on Pain Control in Patients Undergoing Mastectomy, GABS-DART Trial
Trial Status: active
This clinical trial evaluates whether removing gabapentin from the pre-surgical order set of patients undergoing mastectomy affects pain control after surgery. Gabapentin is commonly used to reduce opioid consumption and manage neuropathic pain, but evidence of its effectiveness in surgical settings is limited, and its use is controversial. Some studies show that using gabapentin around the time of surgery may reduce the amount of opioid pain medicines patients need after surgery, but it also has the potential for increased side effects. The standard set of orders added to a patient's medical record before mastectomy includes a default selection of gabapentin use. This study evaluates whether altering these orders to remove the default selection of gabapentin results in changes to pain outcomes in patients undergoing mastectomy.
Inclusion Criteria
Age 18 to 65 years
Undergoing ambulatory extended recover (AXR) mastectomy (bilateral or unilateral) at the Josie Robertson Surgical Center (JSRC)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07308717.
I. Determine the effect of peri-operative gabapentin use on pain control in the post-anesthesia care unit (PACU) operationalized as the top quartile of postoperative morphine milligram equivalents (MMEs) required in patients undergoing mastectomy.
SECONDARY OBJECTIVE:
I. Determine the effect of peri-operative gabapentin use on secondary outcomes related to pain control and post-operative recovery: intraoperative MME, highest pain score reported in the PACU, delayed ambulation, discharge time, use of opioids 30 days post-procedure, and quality of life metrics as captured by the Recovery Tracker (an electronic questionnaire used routinely to collect patient reported outcomes, including level of pain, for ten days after surgery at Memorial Sloan Kettering [MSK]).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients have a standard pre-surgical order set with default selection of gabapentin added to their electronic health record (EHR).
ARM B: Patients have a modified pre-surgical order set without default selection of gabapentin added to their EHR.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center