NOCITA Pain Control in Dogs Receiving TPLO
Masked, randomized, placebo-controlled study of the efficacy of bupivacaine liposomal injectable suspension (NOCITA) using static body weight distribution and subjective pain scoring in dogs undergoing TPLO surgery.
Brief Explanation of Study:
The purpose of this study is to determine whether an injectable pain medication (NOCITA) given immediately after surgery provides better pain control than standard post-operative medications. Post-operative pain in dogs can be challenging to manage, especially when patients are transitioned from injectable pain medications to oral medications (typically around 24 hours after surgery). Commonly, oral non-steroidal anti-inflammatory drugs (NSAIDs) are used in this period due to their proven efficacy. However, pain can still occur in some patients. A long-acting local anesthetic agent that is able to add significant pain control beyond that achieved by oral pain medications would be particularly desirable. NOCITA is an example of this type of agent and it can be administered immediately after surgery directly into the incision site.
What does enrollment into this trial involve?
This study will be conducted over two days. An initial screening assessment will be performed to ensure that your dog is a candidate for the study. If your dog is enrolled into the study he/she will have an initial stance analysis and pain score performed followed by surgery, tibial plateau levelling osteotomy (TPLO) on the first day of the study. Your dog will stay in the hospital two nights after surgery for standard monitoring. Stance analysis and pain scoring will be performed several times during the 48 hours after surgery. Your dog will be able to go home the afternoon of the second day after surgery unless judged otherwise by his attending clinician.
The only procedures performed on your dog for the purposes of the study will be the pain score and stance analysis. Pain scoring is a subjective assessment of your dog’s comfort level and involves observing your pet’s behavior, demeanor and response to gentle palpation of the surgical site. Stance analysis involves walking your dog onto a flat mat and having him/her stand on it for approximately 30 seconds. Both of these will be repeated several times during the study.
Pre-operative bloodwork, additional diagnostics, anesthesia and surgery will be performed as determined by your attending clinician based on physical examination of your pet. At the end of surgery, your pet will have an injection into the incision site of either NOCITA or a placebo medication (saline). Patient enrollment will be randomized and double-blinded; therefore, neither you nor the study clinician will know which treatment your pet has received. After surgery, your dog will be given injections of a non-steroidal anti-inflammatory medication commonly used to manage post-operative pain (carprofen – Rimadyl). If at any point your pet is assessed to be painful, additional pain medication will be administered at that time, and your dog will continue to be included in the study for the full study duration.
- Owned pet dogs of any breed or sex, greater than one year of age.
- Orthopedic examination by one of the clinical investigators consistent with diagnosis of cranial cruciate ligament insufficiency
- Sedated standard lateral and craniocaudal stifle radiographs taken at the VHC at least 12 hours before TPLO surgery
- Treatment by TPLO surgery with any of the following variations: arthrotomy, arthroscopy, partial meniscectomy, meniscal release
- Preoperative complete blood count and serum chemistry results do not raise concern for disease that would prohibit patient from receiving carprofen
- Uncontrolled diagnosed or clinically suspected systemic or endocrine disease.
- Surgery within the previous 14 days before TPLO surgery
- Short acting corticosteroid use within the previous 7 days or repository steroid within the previous two months before TPLO surgery
- NSAID use other than carprofen within the previous 7 days before TPLO surgery
- Other analgesic use within the previous 48 hours before TPLO surgery
- Aggressive or anxious temperament that might interfere with stance analysis and subjective pain scoring
- Neurologic disease, confirmed by neurologic examination by one of the clinical investigators
- Bilateral cranial cruciate insufficiency or other orthopedic disease on physical examination
The costs of surgery, radiographs (x-rays) and, anesthesia incurred by your pet during this visit will not be covered by the study. The cost of the NOCITA or placebo injection will be covered for all dogs enrolled. In addition, the study will pay for the cost of two days hospitalization as well as standard pre-operative blood work (CBC and serum chemistry). These costs will be covered by study funds whether or not your dog is withdrawn from the study.
For more information, please contact Kris Richardson, Clinical Trials Coordinator:
Phone: (785)532-3046; E-mail: ClinicalTrials@vet.k-state.edu