Efficacy of Ropivacaine Hydrochloride in Medial Transversus Abdominis Plane and Rectus Sheath Blocks for Inguinal Hernia Surgery Recovery

The primary objective of this study is to evaluate the **efficacy** of combined rectus sheath (RS) and transversus abdominis plane (TAP) blocks in patients undergoing open inguinal hernia surgery. This assessment aims to determine whether the combination of RS and TAP blocks offers a clinical advantage over the use of a TAP block alone. The clinical relevance of this objective lies in potentially improving postoperative pain management and recovery outcomes for patients undergoing this common surgical procedure.

Secondary objectives include the assessment of the efficacy of the TAP and RS blocks individually. This will provide insights into the individual contributions of each block type to the overall analgesic effect, which is crucial for optimizing pain management strategies in inguinal hernia surgery recovery.

The clinical trial focuses on individuals undergoing recovery from **inguinal hernia open surgery**. The study population includes both male and female participants aged 18 years and older. Participants are required to have adequate Finnish language literacy and must be scheduled for unilateral surgery. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on their ability to provide written informed consent and their diagnosis of inguinal hernia. Lifestyle considerations such as diet, physical activity, or habits have not been specified. Key inclusion criteria include being scheduled for open inguinal hernia surgery and having adequate Finnish language literacy.

The clinical trial is designed to evaluate the efficacy of combined **rectus sheath (RS)** and **transversus abdominis plane (TAP)** blocks in patients undergoing open inguinal hernia surgery. This is a prospective, randomized, double-blind study aimed at determining whether the combination of RS and TAP blocks offers superior benefits compared to the use of a TAP block alone. The trial will involve the administration of **ropivacaine hydrochloride** as a local anesthetic and **sodium chloride** as a saline solution for infusion. The study is structured to include a screening visit, multiple follow-up visits, and an end-of-study visit, with the overall duration of the trial extending until December 31, 2038.

Participants will be involved in the study for a maximum treatment period of one day, with the primary endpoint being the measurement of equivalent morphine consumption during the perioperative period and up to seven days post-surgery. Secondary endpoints include assessments of postoperative pain using a numerical rating scale, patient satisfaction with pain management, incidence of postoperative nausea and vomiting, use of rescue analgesia, and any anesthesiologic or surgical complications. The study will also evaluate psychological factors such as depression and anxiety using the BDI and STAI questionnaires.

The sequence of study visits begins with an inclusion (screening) visit to confirm eligibility based on criteria such as age (18 years or older), diagnosis of inguinal hernia, and adequate Finnish language literacy. Follow-up visits will monitor the patient's recovery and response to the anesthetic blocks, while the end-of-study visit will conclude the participant's involvement. Conditions that may lead to early termination from the study include withdrawal of consent or any adverse events that compromise the participant's safety. The trial is not categorized as low intervention and is classified as a Phase III trial, ensuring rigorous evaluation of the intervention's efficacy and safety.

The clinical trial involves the administration of **Ropivacaine hydrochloride**, a local anesthetic, in the form of a **solution for injection**. The product, known as Ropivacaine hydrochloride Kabi 7.5 mg/ml, is manufactured by Fresenius Kabi Polska Sp. z o.o. The active substance, **ropivacaine hydrochloride**, is of chemical origin. The maximum daily dose is 112.5 mg, with the same amount being the maximum total dose allowed during the treatment period. The administration route is via injection, and the treatment period is limited to one day. Participant compliance will be monitored to ensure adherence to the dosing schedule.

In addition to the experimental medication, the study utilizes **Sodium chloride** as a comparator treatment. The product, Natriumchloride 0.9% Fresenius Kabi, is a **solution for infusion** and is also produced by Fresenius Kabi NV/SA. The active substance, **sodium chloride**, is chemically derived. The maximum daily and total dose is 30 ml, administered through injection over a one-day treatment period. This saline solution serves as a standard-of-care therapy to evaluate the efficacy of the experimental treatment.

Another product listed in the trial is NaCl 0.9 solution, which lacks specific pharmaceutical form and active substance details. It is not associated with any particular manufacturer or authorization status. This product is included in the trial documentation but does not play a direct role in the treatment regimen.

The efficacy of the combined rectus sheath (RS) and transversus abdominis plane (TAP) blocks in open inguinal hernia surgery will be assessed through a series of primary and secondary endpoints. The primary endpoint focuses on the equivalent **morphine** consumption during the perioperative period and after surgery. This is further divided into the intraoperative period, the immediate postoperative period (from discharge from the operating room to discharge from the hospital), and the seven postoperative days.

Secondary endpoints include postoperative pain measured by a numerical rating scale (NRS), patient opinion on the efficacy of pain treatment, and postoperative nausea and vomiting (PONV) as indicated by the use of postoperative nausea medications. Additional secondary endpoints involve the use of rescue analgesia, rescue hospitalization, intra- and postoperative durations, intraoperative anesthetic methods, analysis of patient flow, and anesthesiologic and surgical complications. Psychological assessments will be conducted using the Beck Depression Inventory (BDI) and the State-Trait Anxiety Inventory (STAI) queries to evaluate depression and anxiety levels.