Clinical trial NCT05817162: Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP
Official title: Comparison of Temporomandibular Joint Arthrocentesis With Infiltration of PRP + Ropivacaine Versus PRP: Does It Reduce Postoperative Pain?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Temporomandibular Joint Disorders
Keywords: temporomandibular disorders
temporomandibular joint arthrocentesis
ropivacaine
randomized clinical trial
Lead sponsor: Instituto Portugues da Face
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For this randomized clinical trial an appropriate number of sealed envelopes will be prepared: 15 for PRP and 15 for PRP + Ropivacaine. Patients with inclusion criteria will be seen in an orofacial pain session and assessed for pain using the VAS scale, by scoring the degree of pain between 0 (absence of pain) and 10 (maximum pain). Then the patients are proposed for TMJ arthrocentesis.
Primary purpose: TREATMENT

Brief summary: The infiltration of Platelet Rich Plasma (PRP) at the end of Temporomandibular Joint (TMJ) arthrocentesis is already an established procedure in the treatment of Temporomandibular Disorders (TMD). Arthrocentesis is a minimally invasive surgical procedure, which aims to eliminate the inflammatory mediators from the inside of the TMJ. PRP is an autologous concentrate of platelets and growth factors, derived from centrifugated blood. Several studies have described the benefits of PRP: it enhances wound healing because of the presence of cytokines and growth factors, and is also stimulates chondrocytes to biosynthesis of collagen. Ropivacaine is a local anesthetic that has been synthesized for use in infiltration anesthesia and to produce both peripheral and central block. Unlike one of its analogues, Bupivacaine, Ropivacaine anesthetize the sensory fibers without affecting the motor ones. The main goal of this investigation is to test the benefits of adding Ropivacaine to the infiltration of PRP in patients submitted to TMJ arthrocentesis.

Detailed description: To investigate the potential reduction of pain in the postoperative week in patients submitted to temporomandibular joint double portal arthrocentesis with lavage and Platelet Rich Plasma (PRP) the authors designed a double-blind randomized clinical trial, comparing a treatment group with additional ropivacaine and a control group without ropivacaine.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects between the ages of 18-99 years;
* For women of reproductive potential: use of highly effective contraception for at least 1 month prior to the first visit and agreement to use such a method during participation in the study;
* In the opinion of the investigator, the subject is capable of understanding and comprehending the study in question;
* The subject signs the written informed consent form and provides the necessary privacy clearance prior to the start of any study procedures;
* Patients with TMD with an indication for TMJ arthrocentesis: clinical and imaging diagnosis of unilateral or bilateral intra-articular disorder;
* Magnetic resonance imaging (MRI) assessing the intra-articular derangement;
* Radiological findings that most components of the joint were salvageable;
* Dimitroulis classification between 2 and 3.

Exclusion Criteria:

* Subject has had other previous minimally invasive or invasive treatment for TMD;
* Subject has any contraindication to the use of ropivacaine according to the Ropivacaine (Fresenius Kabi) bulletin;
* Subject has a history of allergy to any drug in the study;
* Subject taking analgesic medication prior to treatment for other conditions;
* The subject has an inability to interpret pain scales or to read and interpret the study's target questionnaire;
* Women who are pregnant or breastfeeding. For women of reproductive potential, use of highly effective contraception for at least 1 month prior to the first visit is required (Combined oral contraceptive pill, vaginal ring, male and female condom, intrauterine device, diaphragm, injectable hormonal contraceptive) and agreement to use such a method during study participation.
* Subjects under 18 and over 99 years old;
* Subjects diagnosed with the following conditions cannot participate in the study: cardiovascular disorders, peripheral vascular disease, arrhythmias, auriculoventricular conduction disorders, heart failure; hypotension, epileptic patients, patients with liver and kidney disease, patients with porphyria, patients with acidosis.
* Subjects with severe medical problems and mental illness.

Primary outcomes:
measure: TMJ Pain
timeFrame: In the first week at a consultation after injection and TMJ arthrocentesis
Secondary outcomes:
measure: Postoperative pain
timeFrame: Daily 1 week after TMJ arthrocentesis and infiltration
measure: General state pre vs post
timeFrame: Daily 1 week after TMJ arthrocentesis and infiltration
measure: Functional limitation chewing foods
timeFrame: Daily 1 week after TMJ arthrocentesis and infiltration
measure: Difficulty closing and mouth opening
timeFrame: Daily 1 week after TMJ arthrocentesis and infiltration
measure: TMJ pain, muscular pain, ear pain
timeFrame: Daily 1 week after TMJ arthrocentesis and infiltration
measure: Interrupt meals
timeFrame: Daily 1 week after TMJ arthrocentesis and infiltration
measure: Sleep been interrupted
timeFrame: Daily 1 week after TMJ arthrocentesis and infiltration
measure: Difficult doing usual jobs
timeFrame: Daily 1 week after TMJ arthrocentesis and infiltration
measure: Unable to work full capacity
timeFrame: Daily 1 week after TMJ arthrocentesis and infiltration
measure: Difficult to relax
timeFrame: Daily 1 week after TMJ arthrocentesis and infiltration
measure: Need of medication after intervention
timeFrame: Daily 1 week after TMJ arthrocentesis and infiltration
measure: TMJ pain assessed by the physiotherapist
timeFrame: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
measure: TMJ pain during lateral deviation assessed by the physiotherapist
timeFrame: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
measure: TMJ pain during protrusion assessed by the physiotherapist
timeFrame: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
measure: Myalgia degree assessed by the physiotherapist
timeFrame: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
measure: Physiotherapist's perception of comfort during the consultation
timeFrame: 1 week after injection and TMJ arthrocentesis in a physiotherapy consultation
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Instituto Português da Face
Study officials:
References:
citation: Derwich M, Mitus-Kenig M, Pawlowska E. Mechanisms of Action and Efficacy of Hyaluronic Acid, Corticosteroids and Platelet-Rich Plasma in the Treatment of Temporomandibular Joint Osteoarthritis-A Systematic Review. Int J Mol Sci. 2021 Jul 9;22(14):7405. doi: 10.3390/ijms22147405.
citation: Keyser C, Bhashyam A, Abdurrob A, Smith JT, Bluman E, Chiodo C. Excess Opioid Disposal Following Orthopaedic Surgery: A Randomized Clinical Trial. Foot Ankle Spec. 2022 Dec;15(6):545-550. doi: 10.1177/1938640020980921. Epub 2020 Dec 27.
citation: Rao TN, Goswami D, Roychoudhury A, Bhutia O, Baidya DK, Trikha A. Efficacy of Local Anesthetic Wound Infiltration in Temporomandibular Joint Ankylosis Surgery for Control of Postoperative Pain: A Prospective, Randomized Controlled, and Double-Blinded Trial. J Oral Maxillofac Surg. 2021 Mar;79(3):559.e1-559.e11. doi: 10.1016/j.joms.2020.10.034. Epub 2020 Oct 29.