Trial Outcomes & Findings for Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy (NCT NCT05172570)
NCT ID: NCT05172570
Last Updated: 2024-03-21
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
20 participants
Primary outcome timeframe
1 hour after surgery
Results posted on
2024-03-21
Participant Flow
Study terminated early-only enrolled 20 subjects
Participant milestones
| Measure |
No Gabapentin
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
7
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
No Gabapentin
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
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.
|
|---|---|---|---|
|
Overall Study
withdrawn-unable to take postop required study meds due to being NPO
|
0
|
1
|
0
|
|
Overall Study
PI Decision due to equipment shortages
|
0
|
0
|
1
|
Baseline Characteristics
Baseline age; continuous demographics
Baseline characteristics by cohort
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin
|
300 mg Gabapentin 3X Per Day
n=7 Participants
Patients will receive 300mg gabapen...
|
300 mg Gabapentin Once Per Day at Night
n=7 Participants
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Age, Continuous
|
64.5 Years
n=99 Participants • Baseline age; continuous demographics
|
64.2 Years
n=107 Participants • Baseline age; continuous demographics
|
51.2 Years
n=206 Participants • Baseline age; continuous demographics
|
60 Years
n=7 Participants • Baseline age; continuous demographics
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants • Baseline age demographics
|
4 Participants
n=107 Participants • Baseline age demographics
|
4 Participants
n=206 Participants • Baseline age demographics
|
12 Participants
n=7 Participants • Baseline age demographics
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants • Baseline age demographics
|
3 Participants
n=107 Participants • Baseline age demographics
|
3 Participants
n=206 Participants • Baseline age demographics
|
8 Participants
n=7 Participants • Baseline age demographics
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants • Baseline ethnicity demographics
|
0 Participants
n=107 Participants • Baseline ethnicity demographics
|
0 Participants
n=206 Participants • Baseline ethnicity demographics
|
0 Participants
n=7 Participants • Baseline ethnicity demographics
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants • Baseline ethnicity demographics
|
7 Participants
n=107 Participants • Baseline ethnicity demographics
|
7 Participants
n=206 Participants • Baseline ethnicity demographics
|
20 Participants
n=7 Participants • Baseline ethnicity demographics
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • Baseline ethnicity demographics
|
0 Participants
n=107 Participants • Baseline ethnicity demographics
|
0 Participants
n=206 Participants • Baseline ethnicity demographics
|
0 Participants
n=7 Participants • Baseline ethnicity demographics
|
|
Overall Number of Baseline Participants
|
6 participants
n=99 Participants
|
7 participants
n=107 Participants
|
7 participants
n=206 Participants
|
20 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 1 hour after surgeryPopulation: 1-hour 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.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
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
Interval 0.0 to 8.0
|
0 score on a scale
Interval 0.0 to 0.0
|
6.7 score on a scale
Interval 0.0 to 10.0
|
|
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
Interval 0.0 to 8.0
|
0 score on a scale
Interval 0.0 to 0.0
|
7.9 score on a scale
Interval 0.0 to 10.0
|
PRIMARY outcome
Timeframe: 24 hour after surgeryPopulation: 24-hour 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.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
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
Interval 0.0 to 8.0
|
3.5 score on a scale
Interval 0.0 to 10.0
|
4.8 score on a scale
Interval 0.0 to 10.0
|
|
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
Interval 0.0 to 8.0
|
4.3 score on a scale
Interval 0.0 to 10.0
|
6.7 score on a scale
Interval 4.0 to 10.0
|
PRIMARY outcome
Timeframe: 48 hour after surgeryPopulation: 48-hour 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.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
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
Interval 0.0 to 9.0
|
1.8 score on a scale
Interval 0.0 to 9.0
|
3.8 score on a scale
Interval 1.0 to 8.0
|
|
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
Interval 2.0 to 9.0
|
3.0 score on a scale
Interval 0.0 to 9.0
|
5.7 score on a scale
Interval 2.0 to 8.0
|
PRIMARY outcome
Timeframe: 72 hour after surgeryPopulation: 72-hour 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.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=7 Participants
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.
|
|---|---|---|---|
|
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
72-hour incision pain
|
4 score on a scale
Interval 3.0 to 6.0
|
2 score on a scale
Interval 0.0 to 6.0
|
3.5 score on a scale
Interval 0.0 to 6.0
|
|
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
Interval 3.0 to 7.0
|
2.7 score on a scale
Interval 1.0 to 6.0
|
5 score on a scale
Interval 4.0 to 7.0
|
PRIMARY outcome
Timeframe: 96 hour after surgeryPopulation: 96-hour 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.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
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
Interval 1.0 to 5.0
|
2.5 score on a scale
Interval 0.0 to 7.0
|
3 score on a scale
Interval 0.0 to 7.0
|
|
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
Interval 5.0 to 8.0
|
2.5 score on a scale
Interval 0.0 to 8.0
|
5 score on a scale
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: 1 hour after surgery.Population: 1-hour Opioid use
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Opioid Usage
|
28.2 morphine equivalent dose-mg/kg
Interval 0.0 to 118.2
|
10.8 morphine equivalent dose-mg/kg
Interval 0.0 to 30.0
|
16.7 morphine equivalent dose-mg/kg
Interval 0.0 to 50.0
|
SECONDARY outcome
Timeframe: 24 hour after surgery.Population: 24-hour Opioid use
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Opioid Usage
|
62.6 morphine equivalent dose-mg/kg
Interval 33.1 to 111.0
|
32.9 morphine equivalent dose-mg/kg
Interval 11.1 to 87.1
|
31.9 morphine equivalent dose-mg/kg
Interval 14.0 to 101.2
|
SECONDARY outcome
Timeframe: 48 hour after surgery.Population: 48-hour opioid use
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Opioid Usage
|
63.9 morphine equivalent dose-mg/kg
Interval 23.7 to 98.7
|
36.2 morphine equivalent dose-mg/kg
Interval 0.0 to 72.8
|
106.4 morphine equivalent dose-mg/kg
Interval 0.0 to 230.8
|
SECONDARY outcome
Timeframe: 72 hour after surgery.Population: 72-hour opioid use
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Opioid Usage
|
64.7 morphine equivalent dose-mg/kg
Interval 22.3 to 185.0
|
44.9 morphine equivalent dose-mg/kg
Interval 0.0 to 95.4
|
74.1 morphine equivalent dose-mg/kg
Interval 7.5 to 152.1
|
SECONDARY outcome
Timeframe: 96 hour after surgery.Population: 96-hour opioid
opioid usage will be collected from electronically medical record as documented by nursing staff admisterning the medications.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Opioid Usage
|
59.6 morphine equivalent dose-mg/kg
Interval 7.5 to 232.0
|
22.5 morphine equivalent dose-mg/kg
Interval 15.0 to 60.0
|
128.5 morphine equivalent dose-mg/kg
Interval 46.0 to 214.4
|
SECONDARY outcome
Timeframe: As it first occurs, up to 96 hours after surgeryPopulation: first opioid request
the timeframe between end of surgery to first opioid request
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Time to First Opioid Request
|
6.86 hours
Interval 1.92 to 14.22
|
8.67 hours
Interval 0.6 to 36.58
|
5.32 hours
Interval 0.5 to 26.87
|
SECONDARY outcome
Timeframe: 1hour after surgery.Population: 1-hour sedation scores 0=awake/alert; 1=quietly awake; 2=asleep/arousable; 3=deep sleep
Sedation is measured as minimum to maximum awareness; high value worse to less awareness (awake/alert, quietly awake, asleep but arousable, deep sleep)
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Sedation Scores
|
2 units on a scale
Interval 2.0 to 2.0
|
1.3 units on a scale
Interval 0.0 to 2.0
|
2 units on a scale
Interval 2.0 to 2.0
|
SECONDARY outcome
Timeframe: 24 hour after surgery.Population: 24-hour sedation scores 0=awake/alert; 1=quietly awake; 2=asleep/arousable; 3=deep sleep
Sedation is measured as minimum to maximum awareness; high value worse to less awareness (awake/alert, quietly awake, asleep but arousable, deep sleep)
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Sedation Scores
|
0.7 units on a scale
Interval 0.0 to 2.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 48 hour after surgery.Population: 48-hour sedation scores 0=awake/alert; 1=quietly awake; 2=asleep/arousable; 3=deep sleep
Sedation is measured as minimum to maximum awareness; high value worse to less awareness (awake/alert, quietly awake, asleep but arousable, deep sleep)
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Sedation Scores
|
0.17 units on a scale
Interval 0.0 to 1.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 72 hour after surgery.Population: 72-hour sedation scores 0=awake/alert; 1=quietly awake; 2=asleep/arousable; 3=deep sleep
Sedation is measured as minimum to maximum awareness; high value worse to less awareness (awake/alert, quietly awake, asleep but arousable, deep sleep)
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Sedation Scores
|
0.17 units on a scale
Interval 0.0 to 1.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 96 hour after surgery.Population: 96-hour sedation scores 0=awake/alert; 1=quietly awake; 2=asleep/arousable; 3=deep sleep
Sedation is measured as minimum to maximum awareness; high value worse to less awareness (awake/alert, quietly awake, asleep but arousable, deep sleep)
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Sedation Scores
|
0.17 units on a scale
Interval 0.0 to 1.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: As they occur up to 96 hours after surgery.Population: Incidence of falls
Participants with one or more falls
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Incidence of Falls
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: As they occur up to 96 hours after surgery.Population: Pulmonary Complications
any incidence of increase oxygen requirements or respiratory depression will be recorded
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=7 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=7 Participants
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.
|
|---|---|---|---|
|
Pulmonary Complications
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From the date of surgery to date of hospital discharge (up to 24 days)Population: Hospital Length of Stay per days
timeframe from start of surgery to time of discharge (up to 24 days)
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=7 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=7 Participants
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.
|
|---|---|---|---|
|
Hospital Length of Stay
|
6.4 days
Interval 3.3 to 7.2
|
5.6 days
Interval 4.0 to 9.0
|
6.5 days
Interval 4.4 to 9.0
|
SECONDARY outcome
Timeframe: 24 hours after surgery.Population: 24-hour delirium
Number of Participants reported they experienced delirium.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Delirium
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 48 hours after surgery.Population: 48-hour delirium
incidence of delirium will be recorded
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Delirium
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 72 hours after surgery.Population: 72-hour delirium
Number of Participants reported they experienced delirium.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Delirium
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 96 hours after surgery.Population: 96-hour delirium
Number of Participants reported they experienced delirium.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Delirium
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 hours after surgery.Population: 24-hour visual disturbances
incidence of any visual disturbance reported by the participants will be reported.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Visual Disturbance
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 48 hours after surgery.Population: 48-hour vusual disturbances
incidence of any visual disturbance reported by the participants will be reported.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Visual Disturbance
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 72 hours after surgery.Population: 72-hour visual disturbances
incidence of any visual disturbance reported by the participants will be reported.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Visual Disturbance
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 96 hours after surgery.Population: 96-hour visual disturbances
incidence of any visual disturbance reported by the participants will be reported.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Visual Disturbance
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 hours after surgery.Population: 24-hour dizinness
incidence of any dizziness reported by the participant reported.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Dizziness
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 48 hours after surgery.Population: 48-hour dizziness
iincidence of any dizziness reported by the participant reported.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Dizziness
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 72 hours after surgery.Population: 72-hour dizziness
incidence of any dizziness reported by the participant reported.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Dizziness
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 96 hours after surgery.Population: 96-hour dizziness
incidence of any dizziness reported by the participant reported.
Outcome measures
| Measure |
No Gabapentin
n=6 Participants
Patients will not receive any gabapentin postoperatively after open thoracotomy
|
300 mg Gabapentin 3X Per Day
n=6 Participants
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Gabapentin: Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
|
300 mg Gabapentin Once Per Day at Night
n=6 Participants
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.
|
|---|---|---|---|
|
Dizziness
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
No Gabapentin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
300 mg Gabapentin 3X Per Day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
300 mg Gabapentin Once Per Day at Night
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Randomized prospective study comparing variable Gabapentin dosages for postoperative analgesia follo
Indiana Univeristy School of Medicine
Phone: 317-274-0275
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place