Study on Patient-Controlled Sedation with Propofol for Women Undergoing Repair of Obstetric Perineal Tears Using Ropivacaine, Lidocaine, and Mepivacaine

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What is this study about?

This clinical trial is focused on improving the experience of women undergoing repair for obstetric perineal lacerations, which are tears that can occur during childbirth. The study is investigating whether adding patient-controlled sedation with a medication called propofol can help reduce pain and discomfort during the procedure. Propofol is an intravenous anesthetic, meaning it is administered through a vein to help with sedation. The standard treatment involves a pudendal nerve block, which is a type of local anesthesia used to numb the area.

In addition to propofol, the study will also involve the use of local anesthetics such as ropivacaine, lidocaine, and mepivacaine. These medications are used to numb specific areas and help manage pain during the repair process. Ropivacaine and mepivacaine are administered through injection, while lidocaine can be applied topically. The purpose of the study is to see if the addition of propofol to these standard treatments can improve the overall experience for patients by reducing pain and discomfort.

Participants in the study will have the opportunity to control their own sedation using a device that administers propofol as needed. This allows them to manage their level of comfort during the procedure. The study will also look at other factors such as anxiety before the procedure, the time it takes to complete the repair, and the ability to have skin-to-skin contact with the baby during the repair. The goal is to gather information on how these treatments affect the patient’s experience and recovery after childbirth.

1 joining the study

Upon joining the study, you will have already provided your signed informed consent after receiving verbal and written information about the trial. This confirms your understanding and willingness to participate.

2 preparation for procedure

Before the procedure begins, you may experience some anxiety. This is normal, and the study aims to assess this feeling as part of the trial.

You will be prepared for the repair of your perineal laceration, which is a tear that can occur during childbirth.

3 procedure and medication

During the procedure, you will receive a pudendal nerve block, which is a type of local anesthesia to help manage pain.

You will also have the option to use patient-controlled sedation with propofol. This means you can control the amount of sedation you receive to help with comfort during the procedure.

The study will monitor the amount of medication used and your level of pain or discomfort during the procedure.

4 post-procedure monitoring

After the procedure, your ability to have skin-to-skin contact with your baby will be assessed.

The time it takes for you to urinate after the procedure will be recorded, as well as the time it takes for you to start moving around again.

Your need for additional pain relief within 24 hours after the procedure will be monitored.

5 follow-up and feedback

Four days after the procedure, you will be asked about your overall experience and any pain relief used postpartum.

This feedback is important to understand the effectiveness of the sedation and pain management methods used during the trial.

Who Can Join the Study?

The patient must be an adult (18 years or older).
The patient must have a planned examination and repair of perineal laceration grades I or II. (These are types of tears that can occur during childbirth.)
The patient must have given her signed informed consent to participate after receiving verbal and written information about the study. (This means she agrees to join the study after understanding what it involves.)
The patient must be female.

Who Cannot Join the Study?

Patients who are not experiencing obstetric perineal lacerations cannot participate. These are tears that occur in the area between the vagina and the anus during childbirth.
Only female patients can participate in this study.
Patients who are under 18 years old cannot participate.
Patients who are pregnant cannot participate.
Patients who have allergies or adverse reactions to propofol cannot participate. Propofol is a medication used to help relax and reduce pain.
Patients with a history of severe reactions to anesthesia cannot participate. Anesthesia is a way to control pain during surgery or procedures.
Patients with certain medical conditions that could interfere with the study cannot participate. This includes conditions that affect the heart, lungs, or liver.
Patients who are currently participating in another clinical trial cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Vrinnevisjukhuset I Norrkoeping Region Oestergoetland	Norrkoping	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	01.04.2023

Trial locations

Investigated drugs:

Propofol is a medication used to help patients relax and feel less pain during medical procedures. In this trial, it is used as a patient-controlled sedation, which means that patients can control how much of the medication they receive to help manage their pain and discomfort during the repair of obstetric perineal lacerations. This approach allows patients to have more control over their sedation level, potentially improving their overall experience during the procedure.

Pudendal Nerve Block is a type of local anesthesia used to numb the area around the pudendal nerve, which can help reduce pain during certain medical procedures. In this trial, it is part of the standard routine for managing pain during the repair of obstetric perineal lacerations. The nerve block helps to decrease pain in the pelvic area, making the procedure more comfortable for the patient.

Investigated diseases:

Perineal injury

Obstetric perineal lacerations – Obstetric perineal lacerations are tears that occur in the perineum, the area between the vaginal opening and the anus, during childbirth. These lacerations are classified into different grades based on their severity, with grade I involving only the vaginal mucosa and perineal skin, and grade II extending into the perineal muscles. The progression of these lacerations typically occurs during the delivery process as the baby passes through the birth canal. The extent of the laceration can vary depending on factors such as the size of the baby, the speed of delivery, and the elasticity of the mother’s tissues. Healing of these lacerations involves the natural repair processes of the body, which may be supported by medical interventions to ensure proper recovery. The healing process can be influenced by factors such as the mother’s overall health, the presence of any infections, and the care provided during the postpartum period.

Trial ID:

2022-502292-39-00

Protocol code:

PROP(ofol)

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Patient-Controlled Sedation with Propofol for Women Undergoing Repair of Obstetric Perineal Tears Using Ropivacaine, Lidocaine, and Mepivacaine

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?