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Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy

Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05172570
Collaborator
(none)
120
Enrollment
1
Location
3
Arms
36.8
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Prospective Study Comparing Variable Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy
Actual Study Start Date :
Apr 6, 2021
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: No Gabapentin

Patients will not receive any gabapentin postoperatively after open thoracotomy
Active Comparator: 300 mg Gabapentin 3X per day

Patients will receive 300mg gabapentin 3x a day after open thoracotomy

Drug: Gabapentin
Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
Other Names:
  • neurontin

    		•
    Active Comparator: 300 mg Gabapentin once per day at night

    Patients will receive 300mg gabapentin once a day at night after open thoracotomy

    Drug: Gabapentin
    Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
    Other Names:
  • neurontin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. The primary endpoint of this study will be incision and chest tube site pain scores. [24 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.

    3. The primary endpoint of this study will be incision and chest tube site pain scores. [48 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.

    4. The primary endpoint of this study will be incision and chest tube site pain scores. [72 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.

    5. The primary endpoint of this study will be incision and chest tube site pain scores. [96 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 Outcome Measures

    1. Opioid Usage [1 hour after surgery.]

      opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.

    2. Opioid Usage [24 hour after surgery.]

      opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.

    3. Opioid Usage [48 hour after surgery.]

      opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.

    4. Opioid Usage [72 hour after surgery.]

      opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.

    5. Opioid Usage [96 hour after surgery.]

      opioid usage will be collected from electronically medical record as documented by nursing staff admisterning the medications.

    6. Time to first Opioid Request [As it first occurs, up to 96 hours after surgery]

      the timeframe between surgery start to first opioid request

    7. 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)

    8. Sedation Scores [24 hour 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)

    9. Sedation Scores [48 hour 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)

    10. Sedation Scores [72 hour 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)

    11. Sedation Scores [96 hour 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)

    12. Incidence of Falls [As they occur up to 96 hours after surgery.]

      any incidence of falls

    13. Pulmonary complications [As they occur up to 96 hours after surgery.]

      any incidence of increase oxygen requirements or respiratory depression will be recorded

    14. Hospital length of stay [From the date of surgery to date of hospital discharge (up to 24 weeks)]

      timeframe from start of surgery to time of discharge (up to 24 weeks)

    15. Delirium [24 hours after surgery.]

      incidence of delirium will be recorded

    16. Delirium [48 hours after surgery.]

      incidence of delirium will be recorded

    17. Delirium [72 hours after surgery.]

      incidence of delirium will be recorded

    18. Delirium [96 hours after surgery.]

      incidence of delirium will be recorded

    19. Visual Disturbance [24 hours after surgery.]

      incidence of any visual disturbance will be recorded

    20. Visual Disturbance [48 hours after surgery.]

      incidence of any visual disturbance will be recorded

    21. Visual Disturbance [72 hours after surgery.]

      incidence of any visual disturbance will be recorded

    22. Visual Disturbance [96 hours after surgery.]

      incidence of any visual disturbance will be recorded

    23. Dizziness [24 hours after surgery.]

      incidence of any dizziness will be recorded

    24. Dizziness [48 hours after surgery.]

      incidence of any dizziness will be recorded

    25. Dizziness [72 hours after surgery.]

      incidence of any dizziness will be recorded

    26. Dizziness [96 hours after surgery.]

      incidence of any dizziness will be recorded

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 indiana University Indianapolis Indiana United States 46202

    Sponsors and Collaborators

    • Indiana University

    Investigators

    • Principal Investigator: Yar Yeap, MD, Indiana University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yar Yeap, Associate Professor of Clinical Anesthesiology, Indiana University
    ClinicalTrials.gov Identifier:
    NCT05172570
    Other Study ID Numbers:
    • 10069
    First Posted:
    Dec 29, 2021
    Last Update Posted:
    Dec 29, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Yar Yeap, Associate Professor of Clinical Anesthesiology, Indiana University
    acute pain
    neuropathic pain
    Additional relevant MeSH terms:
    Pain, Postoperative
    Gabapentin

    Study Results

    No Results Posted as of Dec 29, 2021