This phase III trial studies the effect of gabapentin in reducing opiate use after lung surgery (pulmonary resection). Gabapentin is currently used as part of a multimodal pain regimen (combination of drugs used to control pain). Based on existing research, it is not clear that this drug is helpful in the management of pain and, like any medication, it may have potential side effects. The goal of this research study is to learn if gabapentin does or does not help to reduce opiate use after lung surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05100160.
PRIMARY OBJECTIVE:
I. To determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo.
SECONDARY OBJECTIVE:
I. To evaluate the utility of gabapentin in reducing postoperative pain, reducing hospital length of stay, promoting faster return to baseline function (to be assessed by MD Anderson Symptom Inventory [MDASI]), preventing post thoracotomy pain syndrome (to be assessed by Basic Pain Inventory [BPI]), and reducing the rate of chronic opiate use among patients undergoing thoracic procedures.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive gabapentin orally (PO) once on day of surgery (before surgery), three times daily (TID) for 11 days after surgery, then twice daily (BID) for 1 week, and then once daily (QD) for 1 week.
ARM II: Patients receive placebo PO once on day of surgery (before surgery), TID for 11 days after surgery, then BID for 1 week, and then QD for 1 week.
After completion of study, patients are followed up at 7, 30, 90, and 180 days.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorDavid Christopher Rice
