Pain, Postoperative, Thoracotomy
Conditions
Keywords
acute pain, neuropathic pain
Brief summary
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.
Detailed description
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.
Interventions
DRUGGabapentin
Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Pt undergoing open thoracotomy at Indiana University Hospital * ASA 1,2,3 or 4 * Age 18 or older, male or female
Exclusion criteria
* History of substance abuse in the past 6 months which would include heroin, marijuana or any other illegal street drugs * Patient on home dose of gabapentin or pregabalin * Patient staying intubated after surgery * Patient above 70yo * Patient (home dose) taking more than 30mg PO morphine equivalent (PME) per day * Known allergy or other contraindications to the study medications, which include gabapentin * Patient unable to receive post-op epidural * BMI above 40 * Creatinine clearance less than 30
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 1 hour after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Falls | As they occur up to 96 hours after surgery. | Participants with one or more falls |
| Opioid Usage | 1 hour after surgery. | opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications. |
| Time to First Opioid Request | As it first occurs, up to 96 hours after surgery | the timeframe between end of surgery to first opioid request |
| Sedation Scores | 1hour after surgery. | Sedation is measured as minimum to maximum awareness; high value worse to less awareness (awake/alert, quietly awake, asleep but arousable, deep sleep) |
| Pulmonary Complications | As they occur up to 96 hours after surgery. | any incidence of increase oxygen requirements or respiratory depression will be recorded |
| Delirium | 24 hours after surgery. | Number of Participants reported they experienced delirium. |
| Visual Disturbance | 24 hours after surgery. | incidence of any visual disturbance reported by the participants will be reported. |
| Dizziness | 24 hours after surgery. | incidence of any dizziness reported by the participant reported. |
| Hospital Length of Stay | From the date of surgery to date of hospital discharge (up to 24 days) | timeframe from start of surgery to time of discharge (up to 24 days) |
Countries
United States
Participant flow
Recruitment details
Study terminated early-only enrolled 20 subjects
Participants by arm
| Arm | Count |
|---|---|
| No Gabapentin Patients will not receive any gabapentin | 6 |
| 300 mg Gabapentin 3X Per Day Patients will receive 300mg gabapen... | 7 |
| 300 mg Gabapentin Once Per Day at Night Patients will receive 300mg gabapentin once a day at night after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain. | 7 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | PI Decision due to equipment shortages | 0 | 0 | 1 |
| Overall Study | withdrawn-unable to take postop required study meds due to being NPO | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | No Gabapentin | 300 mg Gabapentin 3X Per Day | 300 mg Gabapentin Once Per Day at Night | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 5 Participants | 0 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 7 Participants | 12 Participants |
| Age, Continuous | 64.5 Years | 64.2 Years | 51.2 Years | 60 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 7 Participants | 7 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Overall Number of Baseline Participants | 6 participants | 7 participants | 7 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 4 Participants | 12 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
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
Population: 24-hour pain scores
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No Gabapentin | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 24-hour incision pain | 2.8 score on a scale |
| No Gabapentin | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 24-hour chest tube pain | 4.3 score on a scale |
| 300 mg Gabapentin 3X Per Day | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 24-hour incision pain | 3.5 score on a scale |
| 300 mg Gabapentin 3X Per Day | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 24-hour chest tube pain | 4.3 score on a scale |
| 300 mg Gabapentin Once Per Day at Night | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 24-hour incision pain | 4.8 score on a scale |
| 300 mg Gabapentin Once Per Day at Night | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 24-hour chest tube pain | 6.7 score on a scale |
Primary
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
Population: 1-hour Pain Scores
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No Gabapentin | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 1-hour incision pain | 3.5 score on a scale |
| No Gabapentin | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 1-hour chest tube pain | 4.8 score on a scale |
| 300 mg Gabapentin 3X Per Day | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 1-hour incision pain | 0 score on a scale |
| 300 mg Gabapentin 3X Per Day | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 1-hour chest tube pain | 0 score on a scale |
| 300 mg Gabapentin Once Per Day at Night | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 1-hour incision pain | 6.7 score on a scale |
| 300 mg Gabapentin Once Per Day at Night | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 1-hour chest tube pain | 7.9 score on a scale |
Primary
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
Population: 96-hour pain scores
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No Gabapentin | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 96-hour incision pain scores | 3.8 score on a scale |
| No Gabapentin | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 96-hour chest tube scores | 6 score on a scale |
| 300 mg Gabapentin 3X Per Day | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 96-hour incision pain scores | 2.5 score on a scale |
| 300 mg Gabapentin 3X Per Day | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 96-hour chest tube scores | 2.5 score on a scale |
| 300 mg Gabapentin Once Per Day at Night | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 96-hour incision pain scores | 3 score on a scale |
| 300 mg Gabapentin Once Per Day at Night | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 96-hour chest tube scores | 5 score on a scale |
Primary
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
Population: 72-hour pain scores
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No Gabapentin | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 72-hour incision pain | 4 score on a scale |
| No Gabapentin | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 72-hour chest tube pain | 5 score on a scale |
| 300 mg Gabapentin 3X Per Day | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 72-hour incision pain | 2 score on a scale |
| 300 mg Gabapentin 3X Per Day | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 72-hour chest tube pain | 2.7 score on a scale |
| 300 mg Gabapentin Once Per Day at Night | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 72-hour incision pain | 3.5 score on a scale |
| 300 mg Gabapentin Once Per Day at Night | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 72-hour chest tube pain | 5 score on a scale |
Primary
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
Population: 48-hour pain scores
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No Gabapentin | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 48-hour incision pain | 4.2 score on a scale |
| No Gabapentin | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 48-hour chest tube pain | 5.7 score on a scale |
| 300 mg Gabapentin 3X Per Day | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 48-hour incision pain | 1.8 score on a scale |
| 300 mg Gabapentin 3X Per Day | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 48-hour chest tube pain | 3.0 score on a scale |
| 300 mg Gabapentin Once Per Day at Night | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 48-hour incision pain | 3.8 score on a scale |
| 300 mg Gabapentin Once Per Day at Night | The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. | 48-hour chest tube pain | 5.7 score on a scale |
Secondary
Delirium
Number of Participants reported they experienced delirium.
Time frame: 72 hours after surgery.
Population: 72-hour delirium
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Gabapentin | Delirium | 0 participants |
| 300 mg Gabapentin 3X Per Day | Delirium | 0 participants |
| 300 mg Gabapentin Once Per Day at Night | Delirium | 0 participants |
Secondary
Delirium
incidence of delirium will be recorded
Time frame: 48 hours after surgery.
Population: 48-hour delirium
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Gabapentin | Delirium | 0 participants |
| 300 mg Gabapentin 3X Per Day | Delirium | 0 participants |
| 300 mg Gabapentin Once Per Day at Night | Delirium | 0 participants |
Secondary
Delirium
Number of Participants reported they experienced delirium.
Time frame: 96 hours after surgery.
Population: 96-hour delirium
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Gabapentin | Delirium | 0 participants |
| 300 mg Gabapentin 3X Per Day | Delirium | 0 participants |
| 300 mg Gabapentin Once Per Day at Night | Delirium | 0 participants |
Secondary
Delirium
Number of Participants reported they experienced delirium.
Time frame: 24 hours after surgery.
Population: 24-hour delirium
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Gabapentin | Delirium | 0 participants |
| 300 mg Gabapentin 3X Per Day | Delirium | 0 participants |
| 300 mg Gabapentin Once Per Day at Night | Delirium | 0 participants |
Secondary
Dizziness
incidence of any dizziness reported by the participant reported.
Time frame: 96 hours after surgery.
Population: 96-hour dizziness
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Gabapentin | Dizziness | 0 participants |
| 300 mg Gabapentin 3X Per Day | Dizziness | 0 participants |
| 300 mg Gabapentin Once Per Day at Night | Dizziness | 0 participants |
Secondary
Dizziness
incidence of any dizziness reported by the participant reported.
Time frame: 72 hours after surgery.
Population: 72-hour dizziness
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Gabapentin | Dizziness | 0 participants |
| 300 mg Gabapentin 3X Per Day | Dizziness | 0 participants |
| 300 mg Gabapentin Once Per Day at Night | Dizziness | 0 participants |
Secondary
Dizziness
iincidence of any dizziness reported by the participant reported.
Time frame: 48 hours after surgery.
Population: 48-hour dizziness
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Gabapentin | Dizziness | 0 participants |
| 300 mg Gabapentin 3X Per Day | Dizziness | 0 participants |
| 300 mg Gabapentin Once Per Day at Night | Dizziness | 0 participants |
Secondary
Dizziness
incidence of any dizziness reported by the participant reported.
Time frame: 24 hours after surgery.
Population: 24-hour dizinness
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Gabapentin | Dizziness | 0 participants |
| 300 mg Gabapentin 3X Per Day | Dizziness | 0 participants |
| 300 mg Gabapentin Once Per Day at Night | Dizziness | 0 participants |
Secondary
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)
Population: Hospital Length of Stay per days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Gabapentin | Hospital Length of Stay | 6.4 days |
| 300 mg Gabapentin 3X Per Day | Hospital Length of Stay | 5.6 days |
| 300 mg Gabapentin Once Per Day at Night | Hospital Length of Stay | 6.5 days |
Secondary
Incidence of Falls
Participants with one or more falls
Time frame: As they occur up to 96 hours after surgery.
Population: Incidence of falls
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Gabapentin | Incidence of Falls | 0 participants |
| 300 mg Gabapentin 3X Per Day | Incidence of Falls | 0 participants |
| 300 mg Gabapentin Once Per Day at Night | Incidence of Falls | 0 participants |
Secondary
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.
Population: 24-hour Opioid use
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Gabapentin | Opioid Usage | 62.6 morphine equivalent dose-mg/kg |
| 300 mg Gabapentin 3X Per Day | Opioid Usage | 32.9 morphine equivalent dose-mg/kg |
| 300 mg Gabapentin Once Per Day at Night | Opioid Usage | 31.9 morphine equivalent dose-mg/kg |
Secondary
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.
Population: 1-hour Opioid use
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Gabapentin | Opioid Usage | 28.2 morphine equivalent dose-mg/kg |
| 300 mg Gabapentin 3X Per Day | Opioid Usage | 10.8 morphine equivalent dose-mg/kg |
| 300 mg Gabapentin Once Per Day at Night | Opioid Usage | 16.7 morphine equivalent dose-mg/kg |
Secondary
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.
Population: 48-hour opioid use
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Gabapentin | Opioid Usage | 63.9 morphine equivalent dose-mg/kg |
| 300 mg Gabapentin 3X Per Day | Opioid Usage | 36.2 morphine equivalent dose-mg/kg |
| 300 mg Gabapentin Once Per Day at Night | Opioid Usage | 106.4 morphine equivalent dose-mg/kg |
Secondary
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.
Population: 72-hour opioid use
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Gabapentin | Opioid Usage | 64.7 morphine equivalent dose-mg/kg |
| 300 mg Gabapentin 3X Per Day | Opioid Usage | 44.9 morphine equivalent dose-mg/kg |
| 300 mg Gabapentin Once Per Day at Night | Opioid Usage | 74.1 morphine equivalent dose-mg/kg |
Secondary
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.
Population: 96-hour opioid
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Gabapentin | Opioid Usage | 59.6 morphine equivalent dose-mg/kg |
| 300 mg Gabapentin 3X Per Day | Opioid Usage | 22.5 morphine equivalent dose-mg/kg |
| 300 mg Gabapentin Once Per Day at Night | Opioid Usage | 128.5 morphine equivalent dose-mg/kg |
Secondary
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.
Population: Pulmonary Complications
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Gabapentin | Pulmonary Complications | 0 participants |
| 300 mg Gabapentin 3X Per Day | Pulmonary Complications | 0 participants |
| 300 mg Gabapentin Once Per Day at Night | Pulmonary Complications | 0 participants |
Secondary
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.
Population: 24-hour sedation scores 0=awake/alert; 1=quietly awake; 2=asleep/arousable; 3=deep sleep
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Gabapentin | Sedation Scores | 0.7 units on a scale |
| 300 mg Gabapentin 3X Per Day | Sedation Scores | 0 units on a scale |
| 300 mg Gabapentin Once Per Day at Night | Sedation Scores | 0 units on a scale |
Secondary
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.
Population: 48-hour sedation scores 0=awake/alert; 1=quietly awake; 2=asleep/arousable; 3=deep sleep
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Gabapentin | Sedation Scores | 0.17 units on a scale |
| 300 mg Gabapentin 3X Per Day | Sedation Scores | 0 units on a scale |
| 300 mg Gabapentin Once Per Day at Night | Sedation Scores | 0 units on a scale |
Secondary
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.
Population: 72-hour sedation scores 0=awake/alert; 1=quietly awake; 2=asleep/arousable; 3=deep sleep
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Gabapentin | Sedation Scores | 0.17 units on a scale |
| 300 mg Gabapentin 3X Per Day | Sedation Scores | 0 units on a scale |
| 300 mg Gabapentin Once Per Day at Night | Sedation Scores | 0 units on a scale |
Secondary
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.
Population: 96-hour sedation scores 0=awake/alert; 1=quietly awake; 2=asleep/arousable; 3=deep sleep
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Gabapentin | Sedation Scores | 0.17 units on a scale |
| 300 mg Gabapentin 3X Per Day | Sedation Scores | 0 units on a scale |
| 300 mg Gabapentin Once Per Day at Night | Sedation Scores | 0 units on a scale |
Secondary
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.
Population: 1-hour sedation scores 0=awake/alert; 1=quietly awake; 2=asleep/arousable; 3=deep sleep
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Gabapentin | Sedation Scores | 2 units on a scale |
| 300 mg Gabapentin 3X Per Day | Sedation Scores | 1.3 units on a scale |
| 300 mg Gabapentin Once Per Day at Night | Sedation Scores | 2 units on a scale |
Secondary
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
Population: first opioid request
| Arm | Measure | Value (MEAN) |
|---|---|---|
| No Gabapentin | Time to First Opioid Request | 6.86 hours |
| 300 mg Gabapentin 3X Per Day | Time to First Opioid Request | 8.67 hours |
| 300 mg Gabapentin Once Per Day at Night | Time to First Opioid Request | 5.32 hours |
Secondary
Visual Disturbance
incidence of any visual disturbance reported by the participants will be reported.
Time frame: 48 hours after surgery.
Population: 48-hour vusual disturbances
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Gabapentin | Visual Disturbance | 0 participants |
| 300 mg Gabapentin 3X Per Day | Visual Disturbance | 0 participants |
| 300 mg Gabapentin Once Per Day at Night | Visual Disturbance | 0 participants |
Secondary
Visual Disturbance
incidence of any visual disturbance reported by the participants will be reported.
Time frame: 24 hours after surgery.
Population: 24-hour visual disturbances
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Gabapentin | Visual Disturbance | 0 participants |
| 300 mg Gabapentin 3X Per Day | Visual Disturbance | 0 participants |
| 300 mg Gabapentin Once Per Day at Night | Visual Disturbance | 0 participants |
Secondary
Visual Disturbance
incidence of any visual disturbance reported by the participants will be reported.
Time frame: 96 hours after surgery.
Population: 96-hour visual disturbances
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Gabapentin | Visual Disturbance | 0 participants |
| 300 mg Gabapentin 3X Per Day | Visual Disturbance | 0 participants |
| 300 mg Gabapentin Once Per Day at Night | Visual Disturbance | 0 participants |
Secondary
Visual Disturbance
incidence of any visual disturbance reported by the participants will be reported.
Time frame: 72 hours after surgery.
Population: 72-hour visual disturbances
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Gabapentin | Visual Disturbance | 0 participants |
| 300 mg Gabapentin 3X Per Day | Visual Disturbance | 0 participants |
| 300 mg Gabapentin Once Per Day at Night | Visual Disturbance | 0 participants |