Gabapentin is a nerve medication that treats pain. The specific aim of the study is to compare the difference in the postoperative use of no gabapentin, 300 mg gabapentin 3x daily, or 300 mg gabapentin once at night. Our hypothesis is that higher doses of gabapentin will correlate with decreased pain at the incision and chest tube sites and decreased opioid consumption.
The purpose of this study is to determine the effectiveness of various dosages of gabapentin, as part of an ERAS protocol, for postoperative analgesic control after open thoracotomy and additionally determine if there is a correlation of the dosage of gabapentin with pulmonary complication and impaired cognition postoperatively. Given the widespread use of gabapentin and the huge variability in dosing, our study aims to simplify ERAS protocols for thoracotomy by figuring out the optimal dosing of gabapentin and whether its use overall decreases postoperative opioid consumption and complications. The specific aim of the study is to compare the difference in the postoperative use of no gabapentin, 300 mg gabapentin 3x daily, or 300 mg gabapentin once at night.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
indiana University
Indianapolis, Indiana, United States
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.
Time frame: 1 hour after surgery
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.
Time frame: 24 hour after surgery
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.
Time frame: 48 hour after surgery
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.
Time frame: 72 hour after surgery
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.
Time frame: 96 hour after surgery
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Opioid Usage
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Time frame: 1 hour after surgery.
Opioid Usage
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Time frame: 24 hour after surgery.
Opioid Usage
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Time frame: 48 hour after surgery.
Opioid Usage
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Time frame: 72 hour after surgery.
Opioid Usage
opioid usage will be collected from electronically medical record as documented by nursing staff admisterning the medications.
Time frame: 96 hour after surgery.
Time to First Opioid Request
the timeframe between end of surgery to first opioid request
Time frame: As it first occurs, up to 96 hours after surgery
Sedation Scores
Sedation is measured as minimum to maximum awareness; high value worse to less awareness (awake/alert, quietly awake, asleep but arousable, deep sleep)
Time frame: 1hour after surgery.
Sedation Scores
Sedation is measured as minimum to maximum awareness; high value worse to less awareness (awake/alert, quietly awake, asleep but arousable, deep sleep)
Time frame: 24 hour after surgery.
Sedation Scores
Sedation is measured as minimum to maximum awareness; high value worse to less awareness (awake/alert, quietly awake, asleep but arousable, deep sleep)
Time frame: 48 hour after surgery.
Sedation Scores
Sedation is measured as minimum to maximum awareness; high value worse to less awareness (awake/alert, quietly awake, asleep but arousable, deep sleep)
Time frame: 72 hour after surgery.
Sedation Scores
Sedation is measured as minimum to maximum awareness; high value worse to less awareness (awake/alert, quietly awake, asleep but arousable, deep sleep)
Time frame: 96 hour after surgery.
Incidence of Falls
Participants with one or more falls
Time frame: As they occur up to 96 hours after surgery.
Pulmonary Complications
any incidence of increase oxygen requirements or respiratory depression will be recorded
Time frame: As they occur up to 96 hours after surgery.
Hospital Length of Stay
timeframe from start of surgery to time of discharge (up to 24 days)
Time frame: From the date of surgery to date of hospital discharge (up to 24 days)
Delirium
Number of Participants reported they experienced delirium.
Time frame: 24 hours after surgery.
Delirium
incidence of delirium will be recorded
Time frame: 48 hours after surgery.
Delirium
Number of Participants reported they experienced delirium.
Time frame: 72 hours after surgery.
Delirium
Number of Participants reported they experienced delirium.
Time frame: 96 hours after surgery.
Visual Disturbance
incidence of any visual disturbance reported by the participants will be reported.
Time frame: 24 hours after surgery.
Visual Disturbance
incidence of any visual disturbance reported by the participants will be reported.
Time frame: 48 hours after surgery.
Visual Disturbance
incidence of any visual disturbance reported by the participants will be reported.
Time frame: 72 hours after surgery.
Visual Disturbance
incidence of any visual disturbance reported by the participants will be reported.
Time frame: 96 hours after surgery.
Dizziness
incidence of any dizziness reported by the participant reported.
Time frame: 24 hours after surgery.
Dizziness
iincidence of any dizziness reported by the participant reported.
Time frame: 48 hours after surgery.
Dizziness
incidence of any dizziness reported by the participant reported.
Time frame: 72 hours after surgery.
Dizziness
incidence of any dizziness reported by the participant reported.
Time frame: 96 hours after surgery.