Ongoing Clinical Trials for Inguinal Hernia
There are currently 5 clinical trials investigating pain management techniques and treatments for patients with inguinal hernia. These studies are taking place across Belgium, Spain, Finland, and Italy, focusing on various approaches to reducing pain during and after hernia repair surgery, as well as evaluating infection prevention strategies and anesthetic safety in children.
Clinical trial locations
- Belgium
- Finland
- Italy
- Spain
Study on Pain Relief for Patients with Inguinal Hernia: Comparing Ropivacaine Hydrochloride TAP Block and Sodium Chloride Local Infiltration
This trial, taking place in Belgium, is comparing two different pain management techniques for patients undergoing laparoscopic hernia repair surgery. The study focuses on adults between 18 and 80 years old who have been diagnosed with a hernia and are classified as having good to moderate overall health status.
Main inclusion criteria: Patients must be between 18 and 80 years old, have a confirmed diagnosis, and be scheduled for laparoscopic repair surgery. Both men and women can participate, and patients should have a health status classified as ASA I to III, meaning they range from healthy to having mild or moderate systemic disease.
Main exclusion criteria: The study excludes individuals with allergies to local anesthetics, bleeding disorders, previous abdominal surgery, severe liver or kidney disease, pregnancy or breastfeeding, a body mass index over 35, or those unable to provide informed consent.
Study focus: The trial aims to determine whether a TAP block, which involves injecting pain-relieving medication into the abdominal wall, provides better pain relief compared to local infiltration at the surgical site. Researchers will monitor pain levels using a numerical rating scale and assess the need for additional pain medication after surgery.
Investigational treatment: The study compares two approaches: the TAP block technique using ropivacaine hydrochloride combined with sodium chloride, and local infiltration where the surgeon injects the anesthetic directly at the surgical site.
Study on the Effect of Levobupivacaine in Reducing Chronic Pain After Open Inguinal Hernia Repair in Patients
This Spanish trial is investigating whether the timing of pain-blocking injections can help prevent long-term pain after open hernia repair surgery. The study specifically looks at chronic pain that persists for three months or more after surgery.
Main inclusion criteria: Participants must be over 18 years old and scheduled for open mesh repair surgery. They need to have a symptomatic hernia confirmed by a doctor or imaging test, be able to provide written informed consent, and have a health classification of ASA I, II, or III.
Main exclusion criteria: The study excludes patients who have not undergone the specific type of surgery being studied, those not experiencing chronic pain after surgery, individuals outside the specified age range, and vulnerable populations requiring special care.
Study focus: Researchers are comparing whether giving a TAP block before the surgical incision is more effective than giving it after the incision in preventing chronic pain. The study will follow patients for three months after surgery to assess pain levels and the need for long-term pain medication.
Investigational treatment: The trial uses ultrasound-guided TAP blocks with levobupivacaine, a local anesthetic that numbs the nerves in the abdominal wall. The key question is whether the timing of this injection makes a difference in long-term pain outcomes.
Study on the Effect of Ropivacaine Hydrochloride and Sodium Chloride on Recovery After Inguinal Hernia Surgery for Patients Undergoing Open Surgery
Conducted in Finland, this trial examines whether combining two different types of pain-blocking techniques provides better pain relief than using just one technique after open hernia surgery.
Main inclusion criteria: Participants must be at least 18 years old, have adequate Finnish language literacy to understand study information, have been diagnosed with a hernia, and be scheduled for open surgery on one side of the body only. They must also be able to provide written informed consent.
Main exclusion criteria: The study excludes patients not undergoing open hernia surgery, those outside the specified age range, individuals not part of the designated clinical trial group, and vulnerable populations.
Study focus: The research compares using both a medial TAP block and a rectus sheath block together versus using only the TAP block. The study monitors how much pain relief medication is needed during and after surgery, pain levels experienced by participants, post-surgery nausea, any complications, and overall patient satisfaction with pain management.
Investigational treatment: The trial uses ropivacaine hydrochloride injected either as a TAP block alone or in combination with a rectus sheath block. Both techniques involve numbing specific nerves in the abdominal area to control pain.
Study on the Necessity of Cefazolin in Preventing Infections After Inguinal or Femoral Hernia Surgery
This Spanish trial, expected to continue until the end of 2025, is investigating whether using antibiotics during hernia surgery is necessary to prevent infections at the surgical site.
Main inclusion criteria: The study is open to men and women over 18 years of age with hernias in the groin area, including those with recurrent hernias that have returned after previous treatment. Participants must be willing to attend scheduled visits and sign an informed consent document.
Main exclusion criteria: Individuals with hernias in the groin area are actually the target population for this study, so the main exclusions relate to age restrictions and vulnerable populations that might need special protection.
Study focus: Researchers are examining whether giving the antibiotic cefazolin during surgery is essential for preventing infections, or whether not using antibiotics is equally effective. Participants will either receive cefazolin or a placebo during their surgery, and doctors will monitor for any surgical site infections in both groups.
Investigational treatment: The study uses antibiotic prophylaxis with cefazolin, administered intravenously as a solution for injection. The goal is to determine if this preventive antibiotic treatment is necessary for all patients undergoing hernia repair surgery.
Study on the Effectiveness and Safety of Chloroprocaine Hydrochloride for Children Undergoing Flat Foot or Inguinal Hernia Surgery
This Italian study focuses on evaluating a local anesthetic specifically for use in children undergoing hernia repair or foot surgery.
Main inclusion criteria: Children and teenagers aged from 28 days after birth to less than 18 years old can participate. For hernia repair, the study includes infants and young children aged 28 days to 6 years. Participants must be normally active and healthy, have normal body weight and height according to pediatric charts, and be classified as ASA I or II. Both parents or guardians and the children themselves must provide written informed consent and be willing to follow study requirements.
Main exclusion criteria: The study excludes patients with allergies to the medication being tested, a history of severe reactions to anesthesia, certain heart conditions, liver or kidney problems, pregnancy or breastfeeding, current use of interfering medications, history of drug or alcohol abuse, or any medical condition that might make participation unsafe.
Study focus: The trial evaluates two different concentrations of chloroprocaine, 1% and 2%, to determine how well the anesthetic works in blocking nerve pain during surgery. Researchers assess how many patients do not require additional anesthesia during surgery, the time it takes for the anesthetic to start working, how long it lasts, pain levels after surgery, and any side effects.
Investigational treatment: The study uses chloroprocaine hydrochloride, administered through an injection near the nerves and guided by ultrasound for precise delivery. Additional medications such as midazolam, fentanyl, tramadol, paracetamol, and sevoflurane may be used for sedation, pain relief, or additional anesthesia if needed.
Summary
The five ongoing clinical trials for hernia treatment demonstrate a strong focus on improving pain management techniques during and after surgery. Four of the five studies concentrate specifically on comparing different regional anesthesia approaches, such as TAP blocks and rectus sheath blocks, using medications like ropivacaine, levobupivacaine, and chloroprocaine.
Geographically, the trials are distributed across Western Europe, with Spain hosting two studies, while Belgium, Finland, and Italy each conduct one trial. A notable aspect is the diversity in patient populations, with most studies focusing on adult patients but one Italian trial specifically examining safety and effectiveness in pediatric patients.
The research approaches vary from comparing timing of anesthetic administration to evaluating combination techniques versus single methods. One Spanish study takes a different direction by questioning the necessity of antibiotic prophylaxis during surgery, addressing infection prevention rather than pain management. Overall, these trials reflect the medical community’s commitment to refining surgical procedures and improving patient comfort and recovery outcomes.
