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Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy

Primary Purpose

Thoracotomy, Pain, Postoperative

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracotomy focused on measuring acute pain, neuropathic pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • indiana UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

No Gabapentin

300 mg Gabapentin 3X per day

300 mg Gabapentin once per day at night

Arm Description

Patients will not receive any gabapentin postoperatively after open thoracotomy

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Opioid Usage
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Opioid Usage
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Opioid Usage
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Opioid Usage
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Opioid Usage
opioid usage will be collected from electronically medical record as documented by nursing staff admisterning the medications.
Time to first Opioid Request
the timeframe between surgery start to first opioid request
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)
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)
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)
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)
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)
Incidence of Falls
any incidence of falls
Pulmonary complications
any incidence of increase oxygen requirements or respiratory depression will be recorded
Hospital length of stay
timeframe from start of surgery to time of discharge (up to 24 weeks)
Delirium
incidence of delirium will be recorded
Delirium
incidence of delirium will be recorded
Delirium
incidence of delirium will be recorded
Delirium
incidence of delirium will be recorded
Visual Disturbance
incidence of any visual disturbance will be recorded
Visual Disturbance
incidence of any visual disturbance will be recorded
Visual Disturbance
incidence of any visual disturbance will be recorded
Visual Disturbance
incidence of any visual disturbance will be recorded
Dizziness
incidence of any dizziness will be recorded
Dizziness
incidence of any dizziness will be recorded
Dizziness
incidence of any dizziness will be recorded
Dizziness
incidence of any dizziness will be recorded

Full Information

First Posted
April 21, 2021
Last Updated
December 10, 2021
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT05172570
Brief Title
Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy
Official Title
Randomized Prospective Study Comparing Variable Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracotomy, Pain, Postoperative
Keywords
acute pain, neuropathic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Gabapentin
Arm Type
No Intervention
Arm Description
Patients will not receive any gabapentin postoperatively after open thoracotomy
Arm Title
300 mg Gabapentin 3X per day
Arm Type
Active Comparator
Arm Description
Patients will receive 300mg gabapentin 3x a day after open thoracotomy
Arm Title
300 mg Gabapentin once per day at night
Arm Type
Active Comparator
Arm Description
Patients will receive 300mg gabapentin once a day at night after open thoracotomy
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
neurontin
Intervention Description
Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
Primary Outcome Measure Information:
Title
The primary endpoint of this study will be incision and chest tube site pain scores.
Description
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
Title
The primary endpoint of this study will be incision and chest tube site pain scores.
Description
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
Title
The primary endpoint of this study will be incision and chest tube site pain scores.
Description
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
Title
The primary endpoint of this study will be incision and chest tube site pain scores.
Description
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
Title
The primary endpoint of this study will be incision and chest tube site pain scores.
Description
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
Secondary Outcome Measure Information:
Title
Opioid Usage
Description
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Time Frame
1 hour after surgery.
Title
Opioid Usage
Description
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Time Frame
24 hour after surgery.
Title
Opioid Usage
Description
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Time Frame
48 hour after surgery.
Title
Opioid Usage
Description
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Time Frame
72 hour after surgery.
Title
Opioid Usage
Description
opioid usage will be collected from electronically medical record as documented by nursing staff admisterning the medications.
Time Frame
96 hour after surgery.
Title
Time to first Opioid Request
Description
the timeframe between surgery start to first opioid request
Time Frame
As it first occurs, up to 96 hours after surgery
Title
Sedation Scores
Description
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.
Title
Sedation Scores
Description
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.
Title
Sedation Scores
Description
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.
Title
Sedation Scores
Description
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.
Title
Sedation Scores
Description
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.
Title
Incidence of Falls
Description
any incidence of falls
Time Frame
As they occur up to 96 hours after surgery.
Title
Pulmonary complications
Description
any incidence of increase oxygen requirements or respiratory depression will be recorded
Time Frame
As they occur up to 96 hours after surgery.
Title
Hospital length of stay
Description
timeframe from start of surgery to time of discharge (up to 24 weeks)
Time Frame
From the date of surgery to date of hospital discharge (up to 24 weeks)
Title
Delirium
Description
incidence of delirium will be recorded
Time Frame
24 hours after surgery.
Title
Delirium
Description
incidence of delirium will be recorded
Time Frame
48 hours after surgery.
Title
Delirium
Description
incidence of delirium will be recorded
Time Frame
72 hours after surgery.
Title
Delirium
Description
incidence of delirium will be recorded
Time Frame
96 hours after surgery.
Title
Visual Disturbance
Description
incidence of any visual disturbance will be recorded
Time Frame
24 hours after surgery.
Title
Visual Disturbance
Description
incidence of any visual disturbance will be recorded
Time Frame
48 hours after surgery.
Title
Visual Disturbance
Description
incidence of any visual disturbance will be recorded
Time Frame
72 hours after surgery.
Title
Visual Disturbance
Description
incidence of any visual disturbance will be recorded
Time Frame
96 hours after surgery.
Title
Dizziness
Description
incidence of any dizziness will be recorded
Time Frame
24 hours after surgery.
Title
Dizziness
Description
incidence of any dizziness will be recorded
Time Frame
48 hours after surgery.
Title
Dizziness
Description
incidence of any dizziness will be recorded
Time Frame
72 hours after surgery.
Title
Dizziness
Description
incidence of any dizziness will be recorded
Time Frame
96 hours after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lyla Farlow, LPN
Phone
3179489804
Email
lychrist@iupui.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Angie Plummer, LPN
Phone
3179447239
Email
plummera@iupui.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yar Yeap, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yar Bye, MD
Phone
317-274-0275
Email
yyeap@iupui.edu
First Name & Middle Initial & Last Name & Degree
Lyla Farlow, LPN
Phone
3179489804
Email
lychrist@iupui.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28097305
Citation
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.
Results Reference
background
PubMed Identifier
25797725
Citation
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. Erratum In: J Am Coll Surg. 2015 May;220(5):986.
Results Reference
background
PubMed Identifier
27500337
Citation
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.
Results Reference
background
PubMed Identifier
29510097
Citation
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.
Results Reference
background
PubMed Identifier
28728783
Citation
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.
Results Reference
background
PubMed Identifier
31804238
Citation
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.
Results Reference
background
PubMed Identifier
30335626
Citation
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.
Results Reference
background
PubMed Identifier
29352586
Citation
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.
Results Reference
background
PubMed Identifier
29530770
Citation
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.
Results Reference
background
PubMed Identifier
26230741
Citation
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.
Results Reference
background
PubMed Identifier
29238824
Citation
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. Erratum In: JAMA Surg. 2018 Apr 1;153(4):396. JAMA Surg. 2022 Jun 1;157(6):553.
Results Reference
background
PubMed Identifier
24574444
Citation
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.
Results Reference
background
PubMed Identifier
21676165
Citation
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.
Results Reference
background
PubMed Identifier
29180889
Citation
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. Erratum In: J Pain Res. 2018 Sep 17;11:1877.
Results Reference
background

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Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy

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