Evaluation of Analgesic Efficacy of Transversus Abdominis Plane Block Versus Local Infiltration with Ropivacaine Hydrochloride in Laparoscopic Inguinal Hernia Repair

The primary objective of this study is to evaluate whether the use of a locoregional technique, specifically a **transversus abdominis plane (TAP) block** or port site wound infiltration, provides superior analgesic efficacy in postoperative pain management for patients undergoing laparoscopic inguinal hernia repair. This is clinically relevant as effective pain management can significantly enhance patient recovery and reduce the risk of complications associated with inadequate analgesia.

The secondary objective is to determine if there is a difference in the reduced intake of analgesics postoperatively between the two groups. This aspect is important for assessing the potential benefits of the TAP block in minimizing the need for additional pain medication, which can further improve patient outcomes and reduce the burden of medication-related side effects.

The clinical trial involves participants diagnosed with **inguinal hernia** who are undergoing laparoscopic inguinal hernia repair operations. The study population includes both male and female subjects, aged between 18 and 80 years, classified as ASA I to III, indicating a range from healthy individuals to those with mild systemic disease. The trial does not include vulnerable populations. Participants were selected based on their scheduled surgical procedure and general health status, ensuring they meet the specified age and ASA classification criteria. The sponsor has not provided information regarding the total number of participants. Lifestyle factors such as diet, physical activity, or habits are not specified as part of the selection criteria for this study.

The clinical trial is designed to evaluate the analgesic efficacy of a **TAP block** compared to local infiltration in patients undergoing laparoscopic inguinal hernia repair. This study is a randomized, controlled trial with a double-blind design to ensure unbiased results. The trial is expected to commence on January 31, 2025, and conclude by October 31, 2025. Participants will be randomly assigned to receive either the test product, **Ropivacaine Fresenius Kabi 7.5 mg/1 ml Solution injectable**, or the placebo, **NaCl 0.9% B. Braun, oplossing voor injectie**. The primary endpoint is the Numeric Rating Scale (NRS) pain score assessed at multiple postoperative time points, while the secondary endpoint involves comparing the amount of dipidolor administered in the PACU and the analgesics used at home.

Study visits will follow a structured sequence, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as ASA I to III classification, age between 18 and 80 years, and undergoing laparoscopic inguinal hernia repair. Follow-up visits will be scheduled to monitor pain scores and analgesic use, ensuring comprehensive data collection. The end-of-study visit will conclude the participant's involvement, summarizing the outcomes and any adverse events. The expected length of participant involvement is up to three days, aligning with the maximum treatment period for the test product. Conditions that may lead to early termination from the study include non-compliance with the protocol, withdrawal of consent, or any adverse events that compromise participant safety.

The clinical trial involves the administration of **Ropivacaine Fresenius Kabi 7.5 mg/1 ml Solution injectable**, which contains the active substance **ropivacaine hydrochloride**. This pharmaceutical form is a **solution for injection** and is administered via injection. The maximum daily dose is 113 mg, with a total maximum dose of 800 mg over a treatment period of up to 3 days. The product is chemically derived and is not a pediatric formulation. The administration of this medication is intended to evaluate its efficacy in providing analgesic effects in patients undergoing laparoscopic inguinal hernia repair.

In addition to the experimental medication, the study utilizes **NaCl 0.9% B. Braun, oplossing voor injectie** as a comparator treatment. This product contains the active substance **sodium chloride** and is also a **solution for injection**. It is administered via injection with a maximum daily and total dose of 40 ml, limited to a treatment period of 1 day. This product serves as a placebo in the trial, allowing for the assessment of the analgesic efficacy of the experimental treatment compared to standard saline solution. Both substances are chemically derived and are not pediatric formulations.

Efficacy in this clinical trial will be assessed primarily through the use of the Numeric Rating Scale (NRS) pain score. This scale will be employed to evaluate pain levels at multiple postoperative time points, providing a quantitative measure of analgesic efficacy. The primary objective is to determine whether a locoregional technique, specifically a Transversus Abdominis Plane (TAP) block or port site wound infiltration, offers superior pain management following laparoscopic inguinal hernia repair.

Secondary efficacy assessments will involve comparing the amount of **dipidolor** administered in the Post-Anesthesia Care Unit (PACU) and the quantity of analgesics used by patients at home. These measures will help to further elucidate the effectiveness of the analgesic techniques under investigation. The trial is designed to ensure that all products are used within their registered indications, aligning with the study's low-intervention classification.