In short
Clinical trials are investigating Mepivacaine Hydrochloride in different patient groups to see how well it helps with pain control and how safe it is in real procedures. The studies focus on people with obstetric perineal tears, children after orthopedic surgery, patients with ischemic stroke, people with hydrocele or spermatocele, and patients needing arterial puncture for blood gas testing.
Key points
- Clinical trials of Mepivacaine Hydrochloride are being done in several different settings, including childbirth-related tears, pediatric surgery, stroke-related symptoms, hydrocele or spermatocele treatment, and arterial puncture pain. Most of the studies are Phase 3 trials, with one Phase 2 study in ischemic stroke. The trials mainly look at pain relief, discomfort, symptom improvement, and treatment response. The target populations include adults, children, and patients with specific procedure-related pain needs. Some studies compare Mepivacaine Hydrochloride with placebo, no local anesthesia, or other local anesthetic approaches.
Trial overview
These studies are testing Mepivacaine Hydrochloride in different clinical situations where pain control is important. The trials are mostly Phase 3 studies, with one Phase 2 study, and all are listed as Authorised. The target groups include adults and children, depending on the condition being studied.
Obstetric perineal lacerations
One Phase 3 trial is studying repair of obstetric perineal lacerations, which are tears in the area between the vagina and anus after childbirth. The study includes 80 participants and looks at whether patient-controlled sedation with propofol, added to standard care with a pudendal nerve block, can reduce pain and discomfort during the procedure. The main endpoint is pain/discomfort during the procedure.
This trial lists Mepivacaine Hydrochloride among the interventions used in the study setting. It also includes other drugs such as ropivacaine, lidocaine, and propofol, which shows that the study is looking at pain control in a broader care plan rather than testing only one medicine.
Pain after pediatric orthopedic surgery
Another Phase 3 trial is studying persistent postoperative pain, which means pain that continues after surgery, in children after orthopedic trauma surgery. The trial plans to enroll 222 participants and aims to show that locoregional analgesia, meaning pain control in a specific body area, can help prevent longer-lasting pain. Mepivacaine Hydrochloride appears in the intervention list as Carbocaine, which is one of the local anesthetic options used in the study.
The main endpoint is pain measured by a Numerical Rating Scale (NRS) 3 months after surgery. This means the researchers are not only checking immediate pain, but also whether pain remains months later.
Ischemic stroke study
The Phase 2 study called MEPI-AVC is evaluating the efficacy and safety of mepivacaine on neurological sequelae, which are health problems that remain after a stroke. The condition studied is ischemic stroke, which happens when blood flow to part of the brain is blocked. This trial includes 38 participants and uses a subcutaneous injection, meaning an injection under the skin.
The main endpoint defines a response as improvement about 1 hour after injection compared with before injection, in at least one clinical score for language, motor skills, or visual skills. In simple terms, the researchers want to know whether symptoms improve shortly after treatment in people with stroke-related problems.
Hydrocele and spermatocele study
One Phase 3 trial is studying hydrocele and spermatocele, which are fluid-filled conditions around the testicle area. The study plans to enroll 300 participants and compares two treatment approaches: Aetoxysclerol alone versus Aetoxysclerol combined with ethanol. The study also looks at pain during treatment with different anesthesia options, including local anesthesia with Mepivacaine Hydrochloride listed as Mepivacaine Accord.
The primary outcomes include symptoms on the treated side 3 months after treatment and pain during treatment measured on a 0-10 scale. The trial also lists several reasons a person may not be suitable for participation, such as allergy to the study agents, language barriers that make the study hard to understand, or a hydrocele/spermatocele that cannot be drained through the skin.
Pain during arterial puncture
The newest listed Phase 3 trial is testing whether infiltrated Mepivacaine Hydrochloride can reduce pain from arterial puncture during blood gas analysis. This study includes 108 participants with respiratory disease or a need for blood gas testing in a pulmonology outpatient clinic. The trial compares Mepivacaine Hydrochloride with placebo and with no local anesthesia at all.
The main endpoint is whether pain from the puncture is reduced. This makes the study especially focused on a common procedure-related pain problem in outpatient care.
Endpoints and who can join
Across these trials, the main outcomes are mostly about pain relief, discomfort, symptom improvement, and response after treatment. Some studies measure results right away during a procedure, while others measure outcomes weeks or months later.
The people who may join depend on the study and the medical problem being treated. The trials include adults after childbirth injury, children after orthopedic trauma surgery, patients with stroke-related symptoms, people with hydrocele or spermatocele, and patients needing arterial puncture for blood gas analysis.