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Study terminated to to shortage if study supplies for epidurals and most enrolled has study deviations due to not receiving correct post study drug assignments.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Gabapentin | No Intervention | Patients will not receive any gabapentin postoperatively after open thoracotomy | |
| 300 mg Gabapentin 3X per day | Active Comparator | Patients will receive 300mg gabapentin 3x a day after open thoracotomy |
|
| 300 mg Gabapentin once per day at night | Active Comparator | Patients will receive 300mg gabapentin once a day at night after open thoracotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Usage | opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications. | 1 hour after surgery. |
| Opioid Usage | opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications. |
Not provided
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yar Yeap, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| indiana University | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28097305 | Background | Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952. | |
| 25797725 | Background | Thiele RH, Rea KM, Turrentine FE, Friel CM, Hassinger TE, McMurry TL, Goudreau BJ, Umapathi BA, Kron IL, Sawyer RG, Hedrick TL. Standardization of care: impact of an enhanced recovery protocol on length of stay, complications, and direct costs after colorectal surgery. J Am Coll Surg. 2015 Apr;220(4):430-43. doi: 10.1016/j.jamcollsurg.2014.12.042. Epub 2015 Jan 9. |
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Study terminated early-only enrolled 20 subjects
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | No Gabapentin | Patients will not receive any gabapentin postoperatively after open thoracotomy |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline demographics
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | No Gabapentin | Patients will not receive any gabapentin |
| BG001 | 300 mg Gabapentin 3X Per Day | Patients will receive 300mg gabapen... |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Baseline characteristics of study participants for each study group. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 1-hour Pain Scores | Posted | Mean | Inter-Quartile Range | score on a scale | 1 hour after surgery |
|
Adverse Events Reported for 6 months
No Adverse Events Reported
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Gabapentin | Patients will not receive any gabapentin postoperatively after open thoracotomy |
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randomized prospective study comparing variable Gabapentin dosages for postoperative analgesia follo | Indiana Univeristy School of Medicine | 317-274-0275 | yyeap@iupui.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2021 | Mar 8, 2024 | Prot_SAP_003.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
Not provided
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|
| 96 hour after surgery |
| 24 hour after surgery. |
| Opioid Usage | opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications. | 48 hour after surgery. |
| Opioid Usage | opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications. | 72 hour after surgery. |
| Opioid Usage | opioid usage will be collected from electronically medical record as documented by nursing staff admisterning the medications. | 96 hour after surgery. |
| Time to First Opioid Request | the timeframe between end of surgery to first opioid request | 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) | 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) | 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) | 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) | 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) | 96 hour after surgery. |
| Incidence of Falls | Participants with one or more falls | As they occur up to 96 hours after surgery. |
| Pulmonary Complications | any incidence of increase oxygen requirements or respiratory depression will be recorded | 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) | From the date of surgery to date of hospital discharge (up to 24 days) |
| Delirium | Number of Participants reported they experienced delirium. | 24 hours after surgery. |
| Delirium | incidence of delirium will be recorded | 48 hours after surgery. |
| Delirium | Number of Participants reported they experienced delirium. | 72 hours after surgery. |
| Delirium | Number of Participants reported they experienced delirium. | 96 hours after surgery. |
| Visual Disturbance | incidence of any visual disturbance reported by the participants will be reported. | 24 hours after surgery. |
| Visual Disturbance | incidence of any visual disturbance reported by the participants will be reported. | 48 hours after surgery. |
| Visual Disturbance | incidence of any visual disturbance reported by the participants will be reported. | 72 hours after surgery. |
| Visual Disturbance | incidence of any visual disturbance reported by the participants will be reported. | 96 hours after surgery. |
| Dizziness | incidence of any dizziness reported by the participant reported. | 24 hours after surgery. |
| Dizziness | iincidence of any dizziness reported by the participant reported. | 48 hours after surgery. |
| Dizziness | incidence of any dizziness reported by the participant reported. | 72 hours after surgery. |
| Dizziness | incidence of any dizziness reported by the participant reported. | 96 hours after surgery. |
| 27500337 | Background | Modesitt SC, Sarosiek BM, Trowbridge ER, Redick DL, Shah PM, Thiele RH, Tiouririne M, Hedrick TL. Enhanced Recovery Implementation in Major Gynecologic Surgeries: Effect of Care Standardization. Obstet Gynecol. 2016 Sep;128(3):457-66. doi: 10.1097/AOG.0000000000001555. |
| 29510097 | Background | Martin LW, Sarosiek BM, Harrison MA, Hedrick T, Isbell JM, Krupnick AS, Lau CL, Mehaffey JH, Thiele RH, Walters DM, Blank RS. Implementing a Thoracic Enhanced Recovery Program: Lessons Learned in the First Year. Ann Thorac Surg. 2018 Jun;105(6):1597-1604. doi: 10.1016/j.athoracsur.2018.01.080. Epub 2018 Mar 3. |
| 28728783 | Background | Brunelli A, Thomas C, Dinesh P, Lumb A. Enhanced recovery pathway versus standard care in patients undergoing video-assisted thoracoscopic lobectomy. J Thorac Cardiovasc Surg. 2017 Dec;154(6):2084-2090. doi: 10.1016/j.jtcvs.2017.06.037. Epub 2017 Jun 22. |
| 31804238 | Background | Ohnuma T, Raghunathan K, Moore S, Setoguchi S, Ellis AR, Fuller M, Whittle J, Pyati S, Bryan WE, Pepin MJ, Bartz RR, Haines KL, Krishnamoorthy V. Dose-Dependent Association of Gabapentinoids with Pulmonary Complications After Total Hip and Knee Arthroplasties. J Bone Joint Surg Am. 2020 Feb 5;102(3):221-229. doi: 10.2106/JBJS.19.00889. |
| 30335626 | Background | Myhre M, Jacobsen HB, Andersson S, Stubhaug A. Cognitive Effects of Perioperative Pregabalin: Secondary Exploratory Analysis of a Randomized Placebo-controlled Study. Anesthesiology. 2019 Jan;130(1):63-71. doi: 10.1097/ALN.0000000000002473. |
| 29352586 | Background | Rogers LJ, Bleetman D, Messenger DE, Joshi NA, Wood L, Rasburn NJ, Batchelor TJP. The impact of enhanced recovery after surgery (ERAS) protocol compliance on morbidity from resection for primary lung cancer. J Thorac Cardiovasc Surg. 2018 Apr;155(4):1843-1852. doi: 10.1016/j.jtcvs.2017.10.151. Epub 2017 Dec 19. |
| 29530770 | Background | Van Haren RM, Mehran RJ, Mena GE, Correa AM, Antonoff MB, Baker CM, Woodard TC, Hofstetter WL, Roth JA, Sepesi B, Swisher SG, Vaporciyan AA, Walsh GL, Rice DC. Enhanced Recovery Decreases Pulmonary and Cardiac Complications After Thoracotomy for Lung Cancer. Ann Thorac Surg. 2018 Jul;106(1):272-279. doi: 10.1016/j.athoracsur.2018.01.088. Epub 2018 Mar 9. |
| 26230741 | Background | Lunn TH, Husted H, Laursen MB, Hansen LT, Kehlet H. Analgesic and sedative effects of perioperative gabapentin in total knee arthroplasty: a randomized, double-blind, placebo-controlled dose-finding study. Pain. 2015 Dec;156(12):2438-2448. doi: 10.1097/j.pain.0000000000000309. |
| 29238824 | Background | Hah J, Mackey SC, Schmidt P, McCue R, Humphreys K, Trafton J, Efron B, Clay D, Sharifzadeh Y, Ruchelli G, Goodman S, Huddleston J, Maloney WJ, Dirbas FM, Shrager J, Costouros JG, Curtin C, Carroll I. Effect of Perioperative Gabapentin on Postoperative Pain Resolution and Opioid Cessation in a Mixed Surgical Cohort: A Randomized Clinical Trial. JAMA Surg. 2018 Apr 1;153(4):303-311. doi: 10.1001/jamasurg.2017.4915. |
| 24574444 | Background | Grosen K, Drewes AM, Hojsgaard A, Pfeiffer-Jensen M, Hjortdal VE, Pilegaard HK. Perioperative gabapentin for the prevention of persistent pain after thoracotomy: a randomized controlled trial. Eur J Cardiothorac Surg. 2014 Jul;46(1):76-85. doi: 10.1093/ejcts/ezu032. Epub 2014 Feb 26. |
| 21676165 | Background | Kinney MA, Mantilla CB, Carns PE, Passe MA, Brown MJ, Hooten WM, Curry TB, Long TR, Wass CT, Wilson PR, Weingarten TN, Huntoon MA, Rho RH, Mauck WD, Pulido JN, Allen MS, Cassivi SD, Deschamps C, Nichols FC, Shen KR, Wigle DA, Hoehn SL, Alexander SL, Hanson AC, Schroeder DR. Preoperative gabapentin for acute post-thoracotomy analgesia: a randomized, double-blinded, active placebo-controlled study. Pain Pract. 2012 Mar;12(3):175-83. doi: 10.1111/j.1533-2500.2011.00480.x. Epub 2011 Jun 16. |
| 29180889 | Background | Savelloni J, Gunter H, Lee KC, Hsu C, Yi C, Edmonds KP, Furnish T, Atayee RS. Risk of respiratory depression with opioids and concomitant gabapentinoids. J Pain Res. 2017 Nov 10;10:2635-2641. doi: 10.2147/JPR.S144963. eCollection 2017. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
| No |
|
| Age, Continuous | Baseline age; continuous demographics | Mean | Full Range | Years |
|
| Sex: Female, Male | Baseline age demographics | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethinicity for each group | Baseline ethnicity demographics | Count of Participants | Participants | No |
|
| Overall Number of Baseline Participants | Baseline Analysis Population Description | Number | participants |
|
| OG002 | 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. |
|
|
| 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. | 24-hour pain scores | Posted | Mean | Inter-Quartile Range | score on a scale | 24 hour after surgery |
|
|
|
| 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. | 48-hour pain scores | Posted | Mean | Inter-Quartile Range | score on a scale | 48 hour after surgery |
|
|
|
| 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. | 72-hour pain scores | Posted | Mean | Inter-Quartile Range | score on a scale | 72 hour after surgery |
|
|
|
| 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. | 96-hour pain scores | Posted | Mean | Inter-Quartile Range | score on a scale | 96 hour after surgery |
|
|
|
| Secondary | Opioid Usage | opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications. | 1-hour Opioid use | Posted | Mean | Inter-Quartile Range | morphine equivalent dose-mg/kg | 1 hour after surgery. |
|
|
|
| Secondary | Opioid Usage | opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications. | 24-hour Opioid use | Posted | Mean | Inter-Quartile Range | morphine equivalent dose-mg/kg | 24 hour after surgery. |
|
|
|
| Secondary | Opioid Usage | opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications. | 48-hour opioid use | Posted | Mean | Inter-Quartile Range | morphine equivalent dose-mg/kg | 48 hour after surgery. |
|
|
|
| Secondary | Opioid Usage | opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications. | 72-hour opioid use | Posted | Mean | Inter-Quartile Range | morphine equivalent dose-mg/kg | 72 hour after surgery. |
|
|
|
| Secondary | Opioid Usage | opioid usage will be collected from electronically medical record as documented by nursing staff admisterning the medications. | 96-hour opioid | Posted | Median | Inter-Quartile Range | morphine equivalent dose-mg/kg | 96 hour after surgery. |
|
|
|
| Secondary | Time to First Opioid Request | the timeframe between end of surgery to first opioid request | first opioid request | Posted | Mean | Full Range | hours | As it first occurs, up to 96 hours after surgery |
|
|
|
| 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) | 1-hour sedation scores 0=awake/alert; 1=quietly awake; 2=asleep/arousable; 3=deep sleep | Posted | Mean | Inter-Quartile Range | units on a scale | 1hour after surgery. |
|
|
|
| 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) | 24-hour sedation scores 0=awake/alert; 1=quietly awake; 2=asleep/arousable; 3=deep sleep | Posted | Mean | Inter-Quartile Range | units on a scale | 24 hour after surgery. |
|
|
|
| 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) | 48-hour sedation scores 0=awake/alert; 1=quietly awake; 2=asleep/arousable; 3=deep sleep | Posted | Mean | Inter-Quartile Range | units on a scale | 48 hour after surgery. |
|
|
|
| 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) | 72-hour sedation scores 0=awake/alert; 1=quietly awake; 2=asleep/arousable; 3=deep sleep | Posted | Mean | Inter-Quartile Range | units on a scale | 72 hour after surgery. |
|
|
|
| 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) | 96-hour sedation scores 0=awake/alert; 1=quietly awake; 2=asleep/arousable; 3=deep sleep | Posted | Mean | Inter-Quartile Range | units on a scale | 96 hour after surgery. |
|
|
|
| Secondary | Incidence of Falls | Participants with one or more falls | Incidence of falls | Posted | Number | participants | As they occur up to 96 hours after surgery. |
|
|
|
| Secondary | Pulmonary Complications | any incidence of increase oxygen requirements or respiratory depression will be recorded | Pulmonary Complications | Posted | Number | participants | As they occur up to 96 hours after surgery. |
|
|
|
| Secondary | Hospital Length of Stay | timeframe from start of surgery to time of discharge (up to 24 days) | Hospital Length of Stay per days | Posted | Mean | Inter-Quartile Range | days | From the date of surgery to date of hospital discharge (up to 24 days) |
|
|
|
| Secondary | Delirium | Number of Participants reported they experienced delirium. | 24-hour delirium | Posted | Number | participants | 24 hours after surgery. |
|
|
|
| Secondary | Delirium | incidence of delirium will be recorded | 48-hour delirium | Posted | Number | participants | 48 hours after surgery. |
|
|
|
| Secondary | Delirium | Number of Participants reported they experienced delirium. | 72-hour delirium | Posted | Number | participants | 72 hours after surgery. |
|
|
|
| Secondary | Delirium | Number of Participants reported they experienced delirium. | 96-hour delirium | Posted | Number | participants | 96 hours after surgery. |
|
|
|
| Secondary | Visual Disturbance | incidence of any visual disturbance reported by the participants will be reported. | 24-hour visual disturbances | Posted | Number | participants | 24 hours after surgery. |
|
|
|
| Secondary | Visual Disturbance | incidence of any visual disturbance reported by the participants will be reported. | 48-hour vusual disturbances | Posted | Number | participants | 48 hours after surgery. |
|
|
|
| Secondary | Visual Disturbance | incidence of any visual disturbance reported by the participants will be reported. | 72-hour visual disturbances | Posted | Number | participants | 72 hours after surgery. |
|
|
|
| Secondary | Visual Disturbance | incidence of any visual disturbance reported by the participants will be reported. | 96-hour visual disturbances | Posted | Number | participants | 96 hours after surgery. |
|
|
|
| Secondary | Dizziness | incidence of any dizziness reported by the participant reported. | 24-hour dizinness | Posted | Number | participants | 24 hours after surgery. |
|
|
|
| Secondary | Dizziness | iincidence of any dizziness reported by the participant reported. | 48-hour dizziness | Posted | Number | participants | 48 hours after surgery. |
|
|
|
| Secondary | Dizziness | incidence of any dizziness reported by the participant reported. | 72-hour dizziness | Posted | Number | participants | 72 hours after surgery. |
|
|
|
| Secondary | Dizziness | incidence of any dizziness reported by the participant reported. | 96-hour dizziness | Posted | Number | participants | 96 hours after surgery. |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
Not provided
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
|
|
|
|