Sustained Release Lidocaine for the Treatment of Postoperative Pain

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  19 and up

Participation Criteria

Inclusion Criteria:

* Any sex, aged ≥ 19 years
* Indication to undergo an operation with a planned pelvic incision
* Able and willing to provide informed consent
* Stated willingness to comply with all study procedures and availability for the duration of the study
* If sexually active, is willing to use adequate birth control methods to prevent pregnancy over the course of the study

Exclusion Criteria:

* History of chronic pain conditions associated with the use of opioids or steroids
* Known allergic reactions to any components of the investigational product
* Active infection involving the surgical site
* Any contraindication to local anesthesia with lidocaine (e.g., known hypersensitivity to anesthetics of the amide type, known hypokalemia, complete heart block, anticoagulants (ASA permitted) antiarrhythmic medication)
* Use of prohibited medications (quinidine, procainamide, disopyramide, lidocaine, mexiletine, flecainide, propafenone, amiodarone, dronedarone, ibutilide, dofetilide, sotalol, vernakalant)
* Has participated in another clinical trial within 3 months prior to the Screening Visit or is planning to participate in another clinical trial during this trial period
* Has any other surgical or medical condition that, in the judgment of the clinical Investigator might warrant exclusion or be contraindicated for safety reason