Does adding patient-controlled sedation with propofol during repair of obstetric perineal lacerations grade I and II improve patient experiences - a randomized control trial

The primary objective of this study is to evaluate the impact of **patient-controlled sedation** with propofol on patient pain and discomfort, as well as the occurrence of complications, during the repair of obstetric perineal lacerations of grade I and II. This is clinically relevant as it aims to enhance patient comfort and potentially reduce procedural complications by integrating patient-controlled sedation into the standard routine, which currently includes a pudendal nerve block. The study does not list any secondary objectives.

The clinical trial focuses on **obstetric perineal lacerations** and involves a study population exclusively composed of adult female patients aged 18 years and older. The trial does not include male participants or vulnerable populations. Participants were selected based on their need for examination and repair of perineal lacerations grades I or II, and all have provided informed consent after receiving comprehensive verbal and written information about the study. The sponsor has not provided the total number of participants involved in the trial. The study does not specify any particular lifestyle considerations such as diet or physical activity. The trial aims to assess patient pain, discomfort, and complications when patient-controlled sedation with propofol is added to the standard routine with pudendal nerve block during the repair procedure.

The clinical trial is designed to evaluate the efficacy of **patient-controlled sedation** with **propofol** in conjunction with standard pudendal nerve block during the repair of obstetric perineal lacerations grades I and II. This study is structured as a randomized, controlled trial, with a double-blind methodology to ensure unbiased results. The trial is expected to span approximately one year, with an estimated recruitment start date of April 1, 2023, and an anticipated end date of March 31, 2024.

Participants will undergo a series of study visits, beginning with an inclusion visit where eligibility is confirmed based on criteria such as being an adult patient (≥18 years) and having planned repair of perineal lacerations grades I or II. Informed consent is required prior to participation. The primary endpoint of the study is to assess periprocedural pain and discomfort, while secondary endpoints include preprocedural anxiety, time to repair, and patient experience postpartum, among others.

Follow-up visits will be scheduled to monitor the patient's recovery and gather data on secondary endpoints, such as the ability to have skin-to-skin contact with the baby during repair and the time to micturition post-procedure. The end-of-study visit will conclude the participant's involvement, ensuring all data is collected and any adverse events are addressed. The expected length of participant involvement is approximately one month, with conditions for early termination including withdrawal of consent or any adverse events that compromise patient safety.

The trial involves the administration of **ropivacaine**, **lidocaine**, and **mepivacaine** as local anesthetics, with **propofol** used for sedation. The maximum daily dose for these anesthetics is set at 100 mg for ropivacaine and lidocaine, and 200 mg for mepivacaine, with a maximum treatment period of one day. The study aims to provide insights into the feasibility and effectiveness of patient-controlled sedation in improving patient experiences during perineal repair.

The clinical trial involves the administration of several **experimental medications** and non-experimental treatments. The primary experimental medication is **anhydrous ropivacaine hydrochloride**, a local anesthetic. It is administered via injection with a maximum daily dose of 100 mg. The pharmaceutical form is designated as PHF00231MIG, and the treatment period is limited to one day. Participant compliance is monitored through standard clinical trial procedures.

Another experimental medication used in the trial is **anhydrous lidocaine hydrochloride**, also a local anesthetic. This medication is applied topically, with a maximum daily dose of 100 mg. The pharmaceutical form is the same as ropivacaine, PHF00231MIG, and the treatment duration is similarly restricted to one day.

**Propofol** is utilized as an intravenous anesthetic agent in this study. It is administered via intravenous bolus use, with a maximum daily dose of 500 mg. The pharmaceutical form is PHF742. Propofol administration is controlled by the patient using a patient-controlled sedation (PCS) device, Syramed®µSP6000, which allows self-administration of the drug to manage sedation levels. The device is certified according to the quality system EN 13485 and does not include a lockout period or background infusions. The nurse anesthetist oversees the procedure, ensuring the patient uses the PCS as needed to manage discomfort.

**Mepivacaine hydrochloride** is another local anesthetic used in the trial, administered via injection. The maximum daily dose is 200 mg, and the pharmaceutical form is PHF00231MIG. The treatment period is one day. Additionally, a combination formulation of mepivacaine, known as **mepivacaine, combinations**, is used to reduce tissue bleeding. It is also administered via injection with the same dosing and pharmaceutical form as mepivacaine hydrochloride.

Throughout the trial, standard-of-care therapy is maintained, and participant compliance is monitored through regular assessments and documentation. The trial aims to evaluate the efficacy and safety of these medications in improving patient experiences during the repair of obstetric perineal lacerations.

Efficacy in this clinical trial will be assessed through a series of primary and secondary endpoints. The primary endpoint is the evaluation of **pain/discomfort** experienced by patients during the procedure. Secondary endpoints include preprocedural anxiety, the time required for the repair of perineal lacerations, the ability to maintain skin-to-skin contact with the baby during the repair, time until micturition post-repair, procedure feasibility, the amount of drugs used during the repair, use of pain relief 24 hours postpartum, patient experience four days postpartum, the need for pain relief within 24 hours postpartum, time to patient mobilization, time to micturition, and perprocedural anxiety.

The trial aims to investigate the impact of adding patient-controlled sedation with **propofol** to the standard routine of pudendal nerve block during the repair of obstetric perineal lacerations of grades I and II. The efficacy parameters will be collected and analyzed at various time points, including during the procedure and up to four days postpartum. The study will utilize patient-reported outcomes and clinical observations to gather data on these endpoints. The trial is designed to provide insights into patient experiences and the potential benefits of the intervention in reducing discomfort and improving overall patient satisfaction during and after the procedure.