Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy
NCT ID: NCT05172570
Last Updated: 2024-03-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
20 participants
INTERVENTIONAL
2021-04-06
2022-03-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No Gabapentin
Patients will not receive any gabapentin postoperatively after open thoracotomy
No interventions assigned to this group
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.
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.
Interventions
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Gabapentin
Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA 1,2,3 or 4
* Age 18 or older, male or female
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Indiana University
OTHER
Responsible Party
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Yar Yeap
Associate Professor of Clinical Anesthesiology
Principal Investigators
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Yar Yeap, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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indiana University
Indianapolis, Indiana, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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10069
Identifier Type: -
Identifier Source: org_study_id
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