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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

  • Journal of Korean Society of Spine Surgery
  • Abbr : J Kor Spine Sur
  • 2019, 26(1), pp.11-20
  • Publisher : Korean Society Of Spine Surgery
  • Research Area : Medicine and Pharmacy > Orthopedic Surgery

Sung-Woo Choi ORD ID 1,  JANG HAE DONG ORD ID 2,  Deokwon Kang 1,  방청원 1,  Jae Chul Lee ORD ID 1,  이재준 1,  Chang Soon Hwang 3,  오근상 3,  Byungjoon Shin 1

1순천향대학교 서울병원 정형외과학교실
2순천향대학교 부천병원 정형외과학교실
3티젤 바이오(주)

Accredited

ABSTRACT

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.

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