Is Perioperative Use of a Combination of Pregabalin and Naproxen Superior to Naproxen Only in Reducing Pain in Ankle Fractures? A Prospective, Randomized, Multicenter Study

Overview

Journal J Orthop Surg Res

Publisher Biomed Central

Specialty Orthopedics

Date 2024 Dec 26

PMID 39726018

Authors

Gi Won Choi

Kwang Hwan Park

Yeo Kwon Yoon

Jin Woo Lee

Dong Woo Shim

Affiliations

Soon will be listed here.

Abstract

Purpose: To compare the analgesic efficacy, adverse effects, and long-term functional outcomes of perioperative naproxen alone versus naproxen with pregabalin for treating pain in ankle fractures.

Methods: This study included 70 patients who underwent operative fixation of rotatory ankle fractures. Group A received naproxen 500 mg only, and Group B received naproxen 500 mg with pregabalin 75 mg 2-hour before surgery and 12 hourly for 14 days thereafter. The minimal clinically important difference of the visual analog scale (VAS) for pain was set at 1.8 out of 10. VAS for pain, opioid consumption, and any adverse effects were recorded for 3 days postoperatively. VAS for pain was checked at 2- and 6-weeks and 3- and 6-months, and functional outcomes were measured at 3- and 6-months postoperatively.

Results: Sixty-three patients (33 and 30 in groups A and B, respectively) completed the 6-month follow-up. Demographic data were similar between groups. VAS for pain did not significantly differ between the groups at any timepoint up to 6 months (P ≥ 0.520), with 95% confidence intervals consistently within 1.8. No significant differences were observed between groups in opioid consumption and functional outcomes (P ≥ 0.211). In group B, dizziness at 48-hour and somnolence at 72-hour were significantly predominant (P ≤ 0.05).

Conclusion: Our study demonstrated comparable pain reduction between two groups following operative fixation of rotatory ankle fractures. However, side effects, including dizziness and somnolence, were predominant in Group B between 48 and 72 h.

References

Chaparro L, Clarke H, Valdes P, Mira M, Duque L, Mitsakakis N . Adding pregabalin to a multimodal analgesic regimen does not reduce pain scores following cosmetic surgery: a randomized trial. J Anesth. 2012; 26(6):829-35. DOI: 10.1007/s00540-012-1447-x. View

White P . The changing role of non-opioid analgesic techniques in the management of postoperative pain. Anesth Analg. 2005; 101(5 Suppl):S5-S22. DOI: 10.1213/01.ANE.0000177099.28914.A7. View

Chung F, Ritchie E, Su J . Postoperative pain in ambulatory surgery. Anesth Analg. 1997; 85(4):808-16. DOI: 10.1097/00000539-199710000-00017. View

Paul J, Nantha-Aree M, Buckley N, Cheng J, Thabane L, Tidy A . Gabapentin does not improve multimodal analgesia outcomes for total knee arthroplasty: a randomized controlled trial. Can J Anaesth. 2013; 60(5):423-31. DOI: 10.1007/s12630-013-9902-1. View

Schmidt P, Ruchelli G, Mackey S, Carroll I . Perioperative gabapentinoids: choice of agent, dose, timing, and effects on chronic postsurgical pain. Anesthesiology. 2013; 119(5):1215-21. DOI: 10.1097/ALN.0b013e3182a9a896. View

Carmichael N, Katz J, Clarke H, Kennedy D, Kreder H, Gollish J . An intensive perioperative regimen of pregabalin and celecoxib reduces pain and improves physical function scores six weeks after total hip arthroplasty: a prospective randomized controlled trial. Pain Res Manag. 2013; 18(3):127-32. PMC: 3673929. DOI: 10.1155/2013/258714. View

Gupta A, Kumar K, Roberts M, Sanders A, Jones M, Levine D . Pain Management After Outpatient Foot and Ankle Surgery. Foot Ankle Int. 2017; 39(2):149-154. DOI: 10.1177/1071100717738495. View

Gardner W, MacDonald D, Kennedy M, Faulkner A, McIntyre J, Forget P . Opioid Prescription Following Wrist and Ankle Fracture Fixation in Scotland-Tradition Prevails. J Clin Med. 2022; 11(2). PMC: 8781195. DOI: 10.3390/jcm11020468. View

Buvanendran A, Kroin J, Tuman K, Lubenow T, Elmofty D, Moric M . Effects of perioperative administration of a selective cyclooxygenase 2 inhibitor on pain management and recovery of function after knee replacement: a randomized controlled trial. JAMA. 2003; 290(18):2411-8. DOI: 10.1001/jama.290.18.2411. View

10.

Pinar H, Karaca O, Karakoc F, Dogan R . Effects of Addition of Preoperative Intravenous Ibuprofen to Pregabalin on Postoperative Pain in Posterior Lumbar Interbody Fusion Surgery. Pain Res Manag. 2017; 2017:1030491. PMC: 5603741. DOI: 10.1155/2017/1030491. View

11.

Todd K, FUNK J . The minimum clinically important difference in physician-assigned visual analog pain scores. Acad Emerg Med. 1996; 3(2):142-6. DOI: 10.1111/j.1553-2712.1996.tb03402.x. View

12.

Kim J, Choi Y, Kim K, Shim J, Lee J, Kwak Y . Effective dose of peri-operative oral pregabalin as an adjunct to multimodal analgesic regimen in lumbar spinal fusion surgery. Spine (Phila Pa 1976). 2011; 36(6):428-33. DOI: 10.1097/BRS.0b013e3181d26708. View

13.

Hill C, Balkenohl M, Thomas D, Walker R, Mathe H, Murray G . Pregabalin in patients with postoperative dental pain. Eur J Pain. 2001; 5(2):119-24. DOI: 10.1053/eujp.2001.0235. View

14.

Rawal N, Hylander J, Nydahl P, Olofsson I, Gupta A . Survey of postoperative analgesia following ambulatory surgery. Acta Anaesthesiol Scand. 1997; 41(8):1017-22. DOI: 10.1111/j.1399-6576.1997.tb04829.x. View

15.

Woolf C, Chong M . Preemptive analgesia--treating postoperative pain by preventing the establishment of central sensitization. Anesth Analg. 1993; 77(2):362-79. DOI: 10.1213/00000539-199377020-00026. View

16.

Engelman E, Cateloy F . Efficacy and safety of perioperative pregabalin for post-operative pain: a meta-analysis of randomized-controlled trials. Acta Anaesthesiol Scand. 2011; 55(8):927-43. DOI: 10.1111/j.1399-6576.2011.02471.x. View

17.

Rbia N, van der Vlies C, Cleffken B, Selles R, Hovius S, Nijhuis T . High Prevalence of Chronic Pain With Neuropathic Characteristics After Open Reduction and Internal Fixation of Ankle Fractures. Foot Ankle Int. 2017; 38(9):987-996. DOI: 10.1177/1071100717712432. View

18.

Helmerhorst G, Lindenhovius A, Vrahas M, Ring D, Kloen P . Satisfaction with pain relief after operative treatment of an ankle fracture. Injury. 2012; 43(11):1958-61. DOI: 10.1016/j.injury.2012.08.018. View

19.

Brummett C, Waljee J, Goesling J, Moser S, Lin P, Englesbe M . New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017; 152(6):e170504. PMC: 7050825. DOI: 10.1001/jamasurg.2017.0504. View

20.

Segal G, Elbaz A, Parsi A, Heller Z, Palmanovich E, Nyska M . Clinical outcomes following ankle fracture: a cross-sectional observational study. J Foot Ankle Res. 2014; 7(1):50. PMC: 4252004. DOI: 10.1186/s13047-014-0050-9. View