A Randomized, Controlled Trial to Assess the Efficacy and Safety of PF-72 Mixed with 0.75% Ropivacaine Hydrochloride in the Management of Postoperative Pain in Patients Undergoing Elective Arthroscopic Shoulder Surgery

Abstract

Background : PF-72 (TGel Bio Co. Ltd., Seoul, Republic of Korea) is a type of temperature-responsive hydrogel. Methods : The eligible patients (n = 72) were randomized to either the trial group (n = 35; PF-72 mixed with 0.75% ropivacaine hydrochloride) or the control group (n = 37; patient-controlled anesthesia). We compared the amount of used rescue analgesics, numeric rating scale (NRS) pain scores, the cumulative area under the curve (AUC0-72) of NRS pain scores and incidences of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). We estimated time-to-events (TTEs). Results : There were significant differences in the amount of used analgesics and NRS pain scores between the two groups at 3, 6, 24, 48 and 72 hours postoperatively (P = 0.000). There were also significant differences in AUC0-6, AUC0-24, AUC0-48 and AUC0-72 of NRS pain scores between the two groups (P = 0.000). There was a significant difference in the proportion of the patients presenting with no pain between the two groups at 3, 6 and 24 hours postoperatively (P = 0.000). There were no significant differences in the incidences of TEAEs and SAEs between the two groups (P > 0.05). TTEs are estimated at 7.486 ± 2.758 (95% confidence interval [CI] 2.081 ± 12.890) hr in the trial group and 9.324 ± 2.488 (95% CI 4.448 ± 14.200) hr in the control group. Conclusion : s: PF-72 mixed with 0.75% ropivacaine hydrochloride is an effective, safe modality in alleviating pain in the patients undergoing elective arthroscopic shoulder surgery.

Keywords

• arthroscopy
• hydrogels
• pain management
• polymers
• shoulder pain