Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Prospective Study Comparing Variable Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy

Conditions
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Thoracotomy, Pain, Postoperative

Intervention / Treatment
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* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Gabapentin<br>Patients will not receive any gabapentin postoperatively after open thoracotomy | |
| Active Comparator: 300 mg Gabapentin 3X per day<br>Patients will receive 300mg gabapentin 3x a day after open thoracotomy | Drug: Gabapentin<br>* Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.<br>* Other names: neurontin;|
| Active Comparator: 300 mg Gabapentin once per day at night<br>Patients will receive 300mg gabapentin once a day at night after open thoracotomy | Drug: Gabapentin<br>* Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.<br>* Other names: neurontin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 96 hour after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 surgery start 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 | any incidence of 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 weeks) | From the date of surgery to date of hospital discharge (up to 24 weeks) | 
| Delirium | incidence of delirium will be recorded | 24 hours after surgery. | 
| Delirium | incidence of delirium will be recorded | 48 hours after surgery. | 
| Delirium | incidence of delirium will be recorded | 72 hours after surgery. | 
| Delirium | incidence of delirium will be recorded | 96 hours after surgery. | 
| Visual Disturbance | incidence of any visual disturbance will be recorded | 24 hours after surgery. | 
| Visual Disturbance | incidence of any visual disturbance will be recorded | 48 hours after surgery. | 
| Visual Disturbance | incidence of any visual disturbance will be recorded | 72 hours after surgery. | 
| Visual Disturbance | incidence of any visual disturbance will be recorded | 96 hours after surgery. | 
| Dizziness | incidence of any dizziness will be recorded | 24 hours after surgery. | 
| Dizziness | incidence of any dizziness will be recorded | 48 hours after surgery. | 
| Dizziness | incidence of any dizziness will be recorded | 72 hours after surgery. | 
| Dizziness | incidence of any dizziness will be recorded | 96 hours after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute pain, neuropathic pain