drugset / Trial / NCT04705480
Pregabalin vs. Gabapentin on Reducing Opioid Usage
Phase 4
Completed
109 enrolled
CAMC Health System
West Virginia Clinical and Translational Science Institute · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a single-center, randomized, open-label, Phase 4 clinical trial investigating the efficacy of multiple-dose administrations of Pregabalin or Gabapentin in combination with traditional opioid pain medications to decrease the amount of opioid pain medication usage in single-system orthopedic trauma patients.
Timeline
- Start
- 2021-04-12
- Primary completion
- 2024-09-30
- Completion
- 2024-12-13
Outcome
Missed primary endpoint
registry analysis (other test); Pregabalin vs Neither Pregabalin Nor Gabapentin; p = 0.557; Wilcoxon (Mann-Whitney) NCT04705480 ↗
registry analysis (other test); Gabapentin vs Neither Pregabalin Nor Gabapentin; p = 0.601; ANCOVA NCT04705480 ↗
Publications
- Background Fabbri A, Voza A, Riccardi A, Serra S, Iaco F; Study and Research Center of the Italian Society of Emergency Medicine (SIMEU). The Pain Management of Trauma Patients in the Emergency Department. J Clin Med. 2023 May 5;12(9):3289. doi: 10.3390/jcm12093289.
- Background Ling W, Mooney L, Hillhouse M. Prescription opioid abuse, pain and addiction: clinical issues and implications. Drug Alcohol Rev. 2011 May;30(3):300-5. doi: 10.1111/j.1465-3362.2010.00271.x.
- Background Florence C, Luo F, Rice K. The economic burden of opioid use disorder and fatal opioid overdose in the United States, 2017. Drug Alcohol Depend. 2021 Jan 1;218:108350. doi: 10.1016/j.drugalcdep.2020.108350. Epub 2020 Oct 27.
- Background Ramirez MF, Kamdar BB, Cata JP. Optimizing Perioperative Use of Opioids: A Multimodal Approach. Curr Anesthesiol Rep. 2020 Dec;10(4):404-415. doi: 10.1007/s40140-020-00413-6. Epub 2020 Sep 7.
- Background Simpson JC, Bao X, Agarwala A. Pain Management in Enhanced Recovery after Surgery (ERAS) Protocols. Clin Colon Rectal Surg. 2019 Mar;32(2):121-128. doi: 10.1055/s-0038-1676477. Epub 2019 Feb 28.
- Background Ahmadi A, Bazargan-Hejazi S, Heidari Zadie Z, Euasobhon P, Ketumarn P, Karbasfrushan A, Amini-Saman J, Mohammadi R. Pain management in trauma: A review study. J Inj Violence Res. 2016 Jul;8(2):89-98. doi: 10.5249/jivr.v8i2.707. Epub 2016 Jul 7.
- Background Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80.
- Background Chin KK, Carroll I, Desai K, Asch S, Seto T, McDonald KM, Curtin C, Hernandez-Boussard T. Integrating Adjuvant Analgesics into Perioperative Pain Practice: Results from an Academic Medical Center. Pain Med. 2020 Jan 1;21(1):161-170. doi: 10.1093/pm/pnz053.
- Background Arumugam S, Lau CS, Chamberlain RS. Use of preoperative gabapentin significantly reduces postoperative opioid consumption: a meta-analysis. J Pain Res. 2016 Sep 12;9:631-40. doi: 10.2147/JPR.S112626. eCollection 2016.
- Background Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
- Background 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.
- Background Campbell R, Khuong JN, Liu Z, Borg C, Jackson S, Ramson DM, Kok J, Douglas N, Penny-Dimri JC, Perry LA. Perioperative gabapentinoid use lowers short-term opioid consumption following lower limb arthroplasty: Systematic review and meta-analysis. J Opioid Manag. 2021 May-Jun;17(3):251-272. doi: 10.5055/jom.2021.0635.
- Background Markman J, Resnick M, Greenberg S, Katz N, Yang R, Scavone J, Whalen E, Gregorian G, Parsons B, Knapp L. Efficacy of pregabalin in post-traumatic peripheral neuropathic pain: a randomized, double-blind, placebo-controlled phase 3 trial. J Neurol. 2018 Dec;265(12):2815-2824. doi: 10.1007/s00415-018-9063-9. Epub 2018 Sep 21.
- Background Gordh TE, Stubhaug A, Jensen TS, Arner S, Biber B, Boivie J, Mannheimer C, Kalliomaki J, Kalso E. Gabapentin in traumatic nerve injury pain: a randomized, double-blind, placebo-controlled, cross-over, multi-center study. Pain. 2008 Aug 31;138(2):255-266. doi: 10.1016/j.pain.2007.12.011. Epub 2008 Feb 6.
- Background Moore RA, Straube S, Wiffen PJ, Derry S, McQuay HJ. Pregabalin for acute and chronic pain in adults. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007076. doi: 10.1002/14651858.CD007076.pub2.
- Background Bockbrader HN, Wesche D, Miller R, Chapel S, Janiczek N, Burger P. A comparison of the pharmacokinetics and pharmacodynamics of pregabalin and gabapentin. Clin Pharmacokinet. 2010 Oct;49(10):661-9. doi: 10.2165/11536200-000000000-00000.
- Background Evoy KE, Sadrameli S, Contreras J, Covvey JR, Peckham AM, Morrison MD. Abuse and Misuse of Pregabalin and Gabapentin: A Systematic Review Update. Drugs. 2021 Jan;81(1):125-156. doi: 10.1007/s40265-020-01432-7.
- Background Dalsgaard H, Kim Peder Dalhoff, Heerfordt IM. A review of the addictive potential of pregabalin and gabapentin. Adverse Drug React Bull. 2024;347(1):1347-1350. doi:https://doi.org/10.1097/fad.0000000000000076
- Background Kuehn BM. Growing Role of Gabapentin in Opioid-Related Overdoses Highlights Misuse Potential and Off-label Prescribing Practices. JAMA. 2022 Oct 4;328(13):1283-1285. doi: 10.1001/jama.2022.13659.
- Background Hahn J, Jo Y, Yoo SH, Shin J, Yu YM, Ah YM. Risk of major adverse events associated with gabapentinoid and opioid combination therapy: A systematic review and meta-analysis. Front Pharmacol. 2022 Oct 11;13:1009950. doi: 10.3389/fphar.2022.1009950. eCollection 2022.
- Background Kharasch ED, Clark JD, Kheterpal S. Perioperative Gabapentinoids: Deflating the Bubble. Anesthesiology. 2020 Aug;133(2):251-254. doi: 10.1097/ALN.0000000000003394. No abstract available.
- Background Patel AS, Abrecht CR, Urman RD. Gabapentinoid Use in Perioperative Care and Current Controversies. Curr Pain Headache Rep. 2022 Feb;26(2):139-144. doi: 10.1007/s11916-022-01012-2. Epub 2022 Jan 27.
- Background Verret M, Lauzier F, Zarychanski R, Perron C, Savard X, Pinard AM, Leblanc G, Cossi MJ, Neveu X, Turgeon AF; Canadian Perioperative Anesthesia Clinical Trials (PACT) Group. Perioperative Use of Gabapentinoids for the Management of Postoperative Acute Pain: A Systematic Review and Meta-analysis. Anesthesiology. 2020 Aug;133(2):265-279. doi: 10.1097/ALN.0000000000003428.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gabapentin | Unknown | 300 mg | Oral |
| Subject | Pregabalin | Small molecule | 50 mg | — |
Indications
No indication recorded.