Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy

Overview

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.

Full Title of Study: “Randomized Prospective Study Comparing Variable Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 30, 2024

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.

Interventions

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

Arms, Groups and Cohorts

  • 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
  • Active Comparator: 300 mg Gabapentin once per day at night
    • Patients will receive 300mg gabapentin once a day at night after open thoracotomy

Clinical Trial Outcome Measures

Primary Measures

  • The primary endpoint of this study will be incision and chest tube site pain scores.
    • Time Frame: 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.
  • The primary endpoint of this study will be incision and chest tube site pain scores.
    • Time Frame: 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.
  • The primary endpoint of this study will be incision and chest tube site pain scores.
    • Time Frame: 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.
  • The primary endpoint of this study will be incision and chest tube site pain scores.
    • Time Frame: 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.
  • The primary endpoint of this study will be incision and chest tube site pain scores.
    • Time Frame: 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 Measures

  • Opioid Usage
    • Time Frame: 1 hour after surgery.
    • opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
  • Opioid Usage
    • Time Frame: 24 hour after surgery.
    • opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
  • Opioid Usage
    • Time Frame: 48 hour after surgery.
    • opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
  • Opioid Usage
    • Time Frame: 72 hour after surgery.
    • opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
  • Opioid Usage
    • Time Frame: 96 hour after surgery.
    • opioid usage will be collected from electronically medical record as documented by nursing staff admisterning the medications.
  • Time to first Opioid Request
    • Time Frame: As it first occurs, up to 96 hours after surgery
    • the timeframe between surgery start to first opioid request
  • Sedation Scores
    • Time Frame: 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)
  • Sedation Scores
    • Time Frame: 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)
  • Sedation Scores
    • Time Frame: 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)
  • Sedation Scores
    • Time Frame: 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)
  • Sedation Scores
    • Time Frame: 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)
  • Incidence of Falls
    • Time Frame: As they occur up to 96 hours after surgery.
    • any incidence of falls
  • Pulmonary complications
    • Time Frame: As they occur up to 96 hours after surgery.
    • any incidence of increase oxygen requirements or respiratory depression will be recorded
  • Hospital length of stay
    • Time Frame: 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)
  • Delirium
    • Time Frame: 24 hours after surgery.
    • incidence of delirium will be recorded
  • Delirium
    • Time Frame: 48 hours after surgery.
    • incidence of delirium will be recorded
  • Delirium
    • Time Frame: 72 hours after surgery.
    • incidence of delirium will be recorded
  • Delirium
    • Time Frame: 96 hours after surgery.
    • incidence of delirium will be recorded
  • Visual Disturbance
    • Time Frame: 24 hours after surgery.
    • incidence of any visual disturbance will be recorded
  • Visual Disturbance
    • Time Frame: 48 hours after surgery.
    • incidence of any visual disturbance will be recorded
  • Visual Disturbance
    • Time Frame: 72 hours after surgery.
    • incidence of any visual disturbance will be recorded
  • Visual Disturbance
    • Time Frame: 96 hours after surgery.
    • incidence of any visual disturbance will be recorded
  • Dizziness
    • Time Frame: 24 hours after surgery.
    • incidence of any dizziness will be recorded
  • Dizziness
    • Time Frame: 48 hours after surgery.
    • incidence of any dizziness will be recorded
  • Dizziness
    • Time Frame: 72 hours after surgery.
    • incidence of any dizziness will be recorded
  • Dizziness
    • Time Frame: 96 hours after surgery.
    • incidence of any dizziness will be recorded

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Indiana University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yar Yeap, Associate Professor of Clinical Anesthesiology – Indiana University
  • Overall Official(s)
    • Yar Yeap, MD, Principal Investigator, Indiana University
  • Overall Contact(s)
    • Lyla Farlow, LPN, 3179489804, lychrist@iupui.edu

References

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.