Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05172570
• Other study ID #: 10069
• Status: Terminated
• Phase: Phase 3
• Start date: April 6, 2021
• Est. completion date: March 2, 2022

Study information

• Verified date: March 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: March 2, 2022
• Est. primary completion date: February 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Thoracotomy

Intervention

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

Locations

Country	Name	City	State
United States	indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Opioid Usage	opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.	1 hour after surgery.
Secondary	Opioid Usage	opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.	24 hour after surgery.
Secondary	Opioid Usage	opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.	48 hour after surgery.
Secondary	Opioid Usage	opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.	72 hour after surgery.
Secondary	Opioid Usage	opioid usage will be collected from electronically medical record as documented by nursing staff admisterning the medications.	96 hour after surgery.
Secondary	Time to First Opioid Request	the timeframe between end of surgery to first opioid request	As it first occurs, up to 96 hours after surgery
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Incidence of Falls	Participants with one or more falls	As they occur up to 96 hours after surgery.
Secondary	Pulmonary Complications	any incidence of increase oxygen requirements or respiratory depression will be recorded	As they occur up to 96 hours after surgery.
Secondary	Hospital Length of Stay	timeframe from start of surgery to time of discharge (up to 24 days)	From the date of surgery to date of hospital discharge (up to 24 days)
Secondary	Delirium	Number of Participants reported they experienced delirium.	24 hours after surgery.
Secondary	Delirium	incidence of delirium will be recorded	48 hours after surgery.
Secondary	Delirium	Number of Participants reported they experienced delirium.	72 hours after surgery.
Secondary	Delirium	Number of Participants reported they experienced delirium.	96 hours after surgery.
Secondary	Visual Disturbance	incidence of any visual disturbance reported by the participants will be reported.	24 hours after surgery.
Secondary	Visual Disturbance	incidence of any visual disturbance reported by the participants will be reported.	48 hours after surgery.
Secondary	Visual Disturbance	incidence of any visual disturbance reported by the participants will be reported.	72 hours after surgery.
Secondary	Visual Disturbance	incidence of any visual disturbance reported by the participants will be reported.	96 hours after surgery.
Secondary	Dizziness	incidence of any dizziness reported by the participant reported.	24 hours after surgery.
Secondary	Dizziness	iincidence of any dizziness reported by the participant reported.	48 hours after surgery.
Secondary	Dizziness	incidence of any dizziness reported by the participant reported.	72 hours after surgery.
Secondary	Dizziness	incidence of any dizziness reported by the participant reported.	96 hours after surgery.