Abstract
BackgroundWe have synthesized a sustained-release lidocaine sheet (SRLS) using biodegradable polymers and previously demonstrated its safety and long-term analgesic effect in the normal mucous membrane of healthy human volunteers.ObjectivesThe aim of this clinical study was to evaluate the efficacy, safety, and appropriate dose of the SRLS for pain following tooth extraction.DesignRandomized, single-blind, dose-response, controlled, clinical study (Phase 1/2).MethodsThe patients in this trial were enrolled between January 2014 and December 2016. A total of 99 patients were randomly divided into 5 groups as follows: the Non-administration group received the conventional extraction; the Poly Lactic-co-Glycolic Acid (PLGA) 100 mg control group received the PLGA matrix without lidocaine; the SRLS 100 mg group received a single sheet of SRLS 100 mg; the SRLS 200 mg group received double sheets of SRLS 100 mg; and the SRLS 400 mg administration group received four sheets of SRLS 100 mg. A study drug was inserted into the defect socket after the extraction, and postoperative pain intensity, satisfaction with postoperative pain relief, adverse events, and postoperative supplemental analgesic rescue use (time, dose) were investigated by patient self-report.ResultsIn total, 94 (94.9%) patients completed the study. There were no significant differences in postoperative pain intensity, satisfaction with postoperative pain relief, and postoperative supplemental analgesic rescue use among the 5 groups. There were no serious side effects, including a plasma concentration increase of lidocaine, attributable to the SRLS.ConclusionsAdministration of the SRLS at 100 mg may have clinical therapeutic potential for pain relief following tooth extraction. The safety of the SRLS for patients undergoing tooth extraction was demonstrated.Trial registrationThe University Hospital Medical Information Network UMIN000011945
Highlights
Postsurgical analgesia is a subject that has recently attracted growing interest, and various postsurgical analgesia methods based on a range of analgesics are used depending on such factors as the nature of the operation and the risk to the patient
A total of patients were randomly divided into 5 groups as follows: the Non-administration group received the conventional extraction; the Poly Lactic-co-Glycolic Acid (PLGA) mg control group received the PLGA matrix without lidocaine; the sustained-release lidocaine sheet (SRLS) 100 mg group received a single sheet of SRLS 100 mg; the SRLS 200 mg group received double sheets of SRLS 100 mg; and the SRLS 400 mg administration group received four sheets of SRLS 100 mg
There were no significant differences in postoperative pain intensity, satisfaction with postoperative pain relief, and postoperative supplemental analgesic rescue use among the 5 groups
Summary
Postsurgical analgesia is a subject that has recently attracted growing interest, and various postsurgical analgesia methods based on a range of analgesics are used depending on such factors as the nature of the operation and the risk to the patient. Operations on patients taking oral anticoagulants and anti-platelet agents have increased, and cases of early postoperative initiation of anticoagulant therapy have increased. Ultrasound-guided peripheral nerve blocks have recently been increasingly used as the resolution of the equipment improves. Such nerve blocks represent a safe and very satisfactory method of pain relief [2,3,4]; the necessity for technology acquisition and the substantial early-phase costs are problematic. We have synthesized a sustained-release lidocaine sheet (SRLS) using biodegradable polymers and previously demonstrated its safety and long-term analgesic effect in the normal mucous membrane of healthy human volunteers
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