Comparison of the Efficacy and Safety Profiles of a Mixed ‘PF-72’ and ‘0.75% Ropivacaine HCl’ Versus a ‘0.75% Ropivacaine HCl’ and No Treatment Group: A Randomized, Single-Blind, Single-Institution Pilot Study

Sung-Woo Choi; JANG HAE DONG; Deokwon Kang; 방청원; Jae Chul Lee; 이재준; Chang Soon Hwang; 오근상; 신병준

Study Design: Prospective pilot study Objectives: The efficacy and safety of ‘PF-72’ for management of postoperative acute pain through a mixed ‘PF-72’ and 0.75% ropivacaine hydrochloride solution in patients with posterior spine surgery was evaluated as ‘0.75% ropivacaine’ and ‘untreated’ controls. Summary of Literature Review: Postoperative acute pain is major surgical side effect that lead to the deterioration of the quality of life. Traditional pain control results in variable side effects, and multimodal pain management has been recommended as an alternative. Local anesthetics is a short-acting time lower than 12 hours. There is controversy about the efficiency and stability of thermoreactive hydrogel products as a drug delivery system. Materials and Methods: Patients scheduled for posterior spine surgery were enrolled by the inclusion criteria. In the treated group, PF- 72 and ropivacaine mixture was injected to the surgical wound before closure. In control group 1, only 0.75% ropivacaine hydrochloride was injected. In the control group 2, the surgical site was without injection. Ten patients were randomly assigned to each group and standardized drugs for pain control were applied postoperatively and rescue regimens were applied when necessary. Postoperative pain score and the cumulative area under the curve (AUC) of pain score were compared. The percentage of subjects who were painless (pain score ≤ 3) was examined at each observation point. The first time of injection and the total dose of the rescue regimen were examined. Postoperative nausea and vomiting (PONV) were also evaluated. Results: There was no significant difference in demographic data. The sum AUC of pain scores in the treated group was significantly lower than that in the control group 1 and 2 at all observation times. The proportion of painless patients was significantly higher in the treated group than in the control group 2. There was no significant difference between the first administration time and the total usage of the rescue regimen, and the percentage of patients with PONV at all time points. There was no statistically significant difference in the incidence of adverse events. Conclusion: PF-72 and ropivacaine mixture showed significant effects for pain management up to 72 hours postoperatively for the patients who underwent posterior spinal surgery without fatal complications.

Citation status

KCI Citation Counts (0)
REFERENCES (22)
열림/닫힘 버튼
* 2021년 이후 발행 논문의 참고문헌은 현재 구축 중입니다.

[journal] Frances Chung / 1995 / Recovery Pattern and Home-Readiness After Ambulatory Surgery / Anesthesia & Analgesia / Ovid Technologies (Wolters Kluwer Health) 80(5) : 896~902 / 10.1097/00000539-199505000-00008.

[journal] Charles E. Argoff / 2013 / Recent Management Advances in Acute Postoperative Pain / Pain Practice / Wiley 14(5) : 477~487 / 10.1111/papr.12108.

[journal] Joanne Fortier / 1998 / Unanticipated admission after ambulatory surgery — a prospective study / Canadian Journal of Anaesthesia / Springer Science and Business Media LLC 45(7) : 612~619 / 10.1007/BF03012088

[journal] Kimberly A. Sutters / 1997 / Inadequate pain management and associated morbidity in children at home after tonsillectomy / Journal of Pediatric Nursing / Elsevier BV 12(3) : 178~185 / 10.1016/s0882-5963(97)80075-9.

[journal] 안은경 / 2002 / The Comparison of Ropivacaine and Bupivacaine in Epidural Patient Controlled Analgesia (PCA) / Korean Journal of Anesthesiology / 대한마취통증의학회 42(5) : 646~652

[journal] Park YS / 1999 / The Effects of Postoperative Patient Controlled Analgesia after Spinal Fusion / J Korean Soc Spine Surg 6(1) : 141~145 / 10.4184/jkss.1999.6.1.141

[journal] Schenk MR / 2006 / Postoperative analgesia after major spine surgery: patient-controlled epidural analgesia versus patient-controlled intravenous analgesia / Anesth Analg 103(5) : 1311~1317 / 10.1213/01.ane/0000247966.49492.72.

[journal] Bianconi M / 2003 / Pharmacokinetics and efficacy of ropivacaine continuous wound instillation after joint replacement surgery / Br J Anaesth 91(6) / 10.1093/bja/aeg277.

[journal] Veerabhadram Garimella / 2013 / Postoperative Pain Control / Clinics in Colon and Rectal Surgery / Georg Thieme Verlag KG 26(03) : 191~196 / 10.1055/s-0033-1351138

[journal] Béatrice Vinson-Bonnet / 2002 / Local Infiltration with Ropivacaine Improves Immediate Postoperative Pain Control After Hemorrhoidal Surgery / Diseases of the Colon & Rectum / Ovid Technologies (Wolters Kluwer Health) 45(1) : 104~108 / 10.1007/s10350-004-6121-4

[journal] Feng Qi / 2016 / Long-term effect of ropivacaine nanoparticles for sciatic nerve block on postoperative pain in rats / International Journal of Nanomedicine / Informa UK Limited : 2081~2090 / 10.2147/ijn.s101563

[journal] Kim T / 2015 / Analgesic effect of intraarticular injection of temperature-responsive hydrogel containing bupivacaine on osteoarthritic pain in rats / Biomed Res Int 2015 : 812949~ / 10.1155/2015/812949.

[journal] Choi DH / 2004 / Anesthesia and Pain Medicine / Korean Society for Intravenous Anesthesia 8(4) : 193~196

[journal] J. Forst / 1999 / Pain therapy following joint replacement / Archives of Orthopaedic and Trauma Surgery / Springer Science and Business Media LLC 119(5-6) : 267~270 / 10.1007/s004020050407

[journal] Charles G. Fisher / 2003 / Prospective Randomized Clinical Trial Comparing Patient-Controlled Intravenous Analgesia With Patient-Controlled Epidural Analgesia After Lumbar Spinal Fusion / Spine / Ovid Technologies (Wolters Kluwer Health) 28(8) : 739~743 / 10.1097/01.brs.0000058943.93281.28.

[journal] James P. Rathmell / 2003 / Intrathecal Morphine for Postoperative Analgesia: A Randomized, Controlled, Dose-Ranging Study After Hip and Knee Arthroplasty / Anesthesia & Analgesia / Ovid Technologies (Wolters Kluwer Health) : 1452~1457 / 10.1213/01.ane.0000083374.44039.9e

[journal] Zongbing You / 2013 / Liposomal extended-release bupivacaine for postsurgical analgesia / Patient Preference and Adherence / Informa UK Limited : 885~890 / 10.2147/ppa.s32175

[journal] Stephen Cohen / 2012 / Extended pain relief trial utilizing infiltration of Exparel®, a long-acting multivesicular liposome formulation of bupivacaine: a Phase IV health economic trial in adult patients undergoing open colectomy / Journal of Pain Research / Informa UK Limited 5 : 567~572 / 10.2147/jpr.s38621

[journal] Kenneth Cummings, III / 2012 / Liposomal bupivacaine: a review of a new bupivacaine formulation / Journal of Pain Research / Informa UK Limited : 257~264 / 10.2147/jpr.s27894.

[journal] Quang Vinh Nguyen / 2015 / Injectable polymeric hydrogels for the delivery of therapeutic agents: A review / European Polymer Journal / Elsevier BV 72 : 602~619 / 10.1016/j.eurpolymj.2015.03.016

[journal] Todd R. Hoare / 2008 / Hydrogels in drug delivery: Progress and challenges / Polymer / Elsevier BV 49(8) : 1993~2007 / 10.1016/j.polymer.2008.01.027.

[journal] Keun Sang Oh / 2019 / Preclinical studies of ropivacaine extended-release from a temperature responsive hydrogel for prolonged relief of pain at the surgical wound / International Journal of Pharmaceutics / Elsevier BV 558 : 225~230 / 10.1016/j.ijpharm.2019.01.011

KJC Korea
Journal Central

Statistics

Tools

Sharing

Issue List

Citation status