Study on Ropivacaine Hydrochloride for Reducing Pain After Hip Surgery in Patients Undergoing Periacetabular Osteotomy

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What is this study about?

This clinical trial is focused on studying the effects of a specific type of pain relief method called the pericapsular nerve group (PENG) block for patients undergoing a surgical procedure known as periacetabular osteotomy. This surgery is typically performed to correct hip problems. The study aims to determine if the PENG block is more effective than a placebo in reducing pain and other complications immediately after the surgery.

During the trial, participants will receive either the PENG block using a medication called Ropivacaine or a placebo, which in this case is Saline. Ropivacaine is a medication used to numb a specific area of the body to help manage pain. The PENG block involves injecting the medication near the nerves around the hip to provide pain relief after the surgery.

The study will monitor participants for 24 hours after their surgery to assess their pain levels and any other complications. This will help researchers understand how effective the PENG block is in managing pain compared to the placebo. The goal is to improve pain management techniques for patients undergoing hip surgery, potentially leading to better recovery experiences.

1 joining the study

Participation begins after providing informed consent and meeting the eligibility criteria, which include being 18 years or older, scheduled for a specific hip surgery, and able to understand Danish.

2 pre-surgery preparation

Before surgery, preparation involves general anesthesia with intubation. The focus is on ensuring readiness for the procedure.

3 administration of study medication

During the surgery, a solution is injected near the nerves around the hip. This could be either ropivacaine hydrochloride or saline. The purpose is to assess pain relief effectiveness.

4 post-surgery monitoring

After surgery, pain levels are monitored using a numeric scale from 0 to 10. This occurs during the first 24 hours, focusing on immediate pain relief and any complications.

5 pain assessment

Pain is assessed upon arrival at the recovery area and every 30 minutes until transfer to the ward. The goal is to evaluate pain at rest and during movement.

6 opioid use tracking

The use of opioids for pain management is tracked from the time of waking up from anesthesia until 24 hours post-surgery.

Who Can Join the Study?

Patients must be 18 years old or older.
Patients must provide informed consent, which means they agree to participate after understanding the study details.
Patients must be scheduled for periacetabular osteotomy, a type of hip surgery, under general anesthesia with intubation, which means they will be asleep and have a tube to help them breathe during the surgery.
Patients must have an American Society of Anesthesiologists (ASA) physical status classification of I to III. This is a way to describe a patient’s overall health, where I means healthy, II means mild health issues, and III means more serious health issues.
Patients must be able to read and understand Danish.

Who Cannot Join the Study?

Patients who are not undergoing a periacetabular osteotomy (a type of hip surgery) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those who cannot give consent, cannot participate.
Patients who do not meet other specific health criteria set by the study cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.06.2024

Trial locations

Investigated drugs:

PENG Block is a type of regional anesthesia used to manage pain. In this trial, it is being tested to see if it can effectively reduce pain after a specific type of hip surgery called periacetabular osteotomy. The PENG block works by numbing the nerves around the hip area, potentially leading to less pain and fewer complications after surgery.

Investigated diseases:

Periacetabular Osteotomy – Periacetabular osteotomy is a surgical procedure used to correct hip dysplasia, a condition where the hip socket does not fully cover the ball portion of the upper thigh bone. This misalignment can lead to joint instability and increased wear on the hip joint. The surgery involves cutting and repositioning the bones around the hip socket to improve its coverage and stability. Over time, this can help reduce pain and improve joint function. The procedure is typically considered for young adults with hip dysplasia to prevent the progression of arthritis. Recovery involves a period of limited weight-bearing and physical therapy to regain strength and mobility.

Trial ID:

2024-513688-25-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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