Study on Post-Surgery Pain Relief for Radius Fracture Patients Using Ropivacaine and Oxycodone

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What is this study about?

This clinical trial is focused on studying the effects of different concentrations of a medication called ropivacaine on pain experienced after surgery for a type of wrist fracture known as a radius fracture. The surgery involves using a volar plate, which is a method to stabilize the broken bone. The trial aims to understand if the concentration of ropivacaine, used in a nerve block, affects the severity of pain after the operation.

Participants in the study will receive either a lower concentration (3.75 mg/ml) or a higher concentration (7.5 mg/ml) of ropivacaine. This medication is administered as an injection to numb the area around the shoulder, known as the infraclavicular brachial plexus block, to help manage pain during and after the surgery. The study will compare the pain levels experienced by participants receiving the different concentrations of ropivacaine.

Throughout the study, participants’ pain levels will be monitored at various intervals, including immediately after surgery and up to six weeks later. The study will also track the use of additional pain relief medications, such as OxyContin, OxyNorm, ARCOXIA, Paracet, and Dexamethasone, to understand their impact on managing pain. The goal is to determine the most effective concentration of ropivacaine for reducing pain after this type of surgery.

1 joining the trial

Upon joining the trial, the patient will be informed about the study’s purpose, which is to investigate if the severity of postoperative pain is related to the concentration of ropivacaine used during surgery.

The patient will be required to provide signed informed consent, confirming their understanding and willingness to participate in the study.

2 pre-surgery preparation

Before the surgery, the patient will undergo a sensory and motor test to assess the adequacy of the nerve block.

The patient will receive an injection of ropivacaine at either 3.75 mg/ml or 7.5 mg/ml concentration to block pain during the surgery.

3 surgery

The patient will undergo volar plate surgery for a radius fracture. The adequacy of the nerve block for surgery will be assessed.

4 post-surgery care

After surgery, the patient will be monitored in the post-anesthesia care unit (PACU).

Pain levels will be measured using the Verbal Numeric Rating Score (VNRS) from 0 to 10 at various intervals: 8 hours, 24 hours, 48 hours, 3 days, and 7 days after surgery.

5 medication administration

The patient will receive OxyContin 10 mg prolonged-release tablets orally, OxyNorm 10 mg/ml solution for injection or infusion, and Oxycodone Actavis 5 mg hard capsules as needed for pain management.

Additional medications include ARCOXIA 120 mg and 90 mg film-coated tablets, Paracet 500 mg and 1 g tablets, and Dexamethasone Orifarm 4 mg tablets, all administered orally.

6 pain and recovery assessment

The patient will report pain levels at rest and with movement at 6 weeks after surgery using VNRS and a Likert scale.

The patient will also provide feedback on the quality of sleep, work ability, social life, and cognitive function at various intervals: the first night, 48 hours, 3 days, 7 days, and 6 weeks after surgery.

7 final evaluation

At the end of the trial, the patient will be asked about their satisfaction with pain treatment and whether they experienced bothersome pain.

The patient will also describe the type of pain experienced at block resolution, such as heat, cold, burning, prickly, tingling, itchy, or squeezing sensations.

Who Can Join the Study?

Adult patients with a radius fracture, scheduled for surgery with a volar plate within 20 days after the fracture.
Patients classified as ASA I, II, and stable ASA III. This means patients are generally healthy, have mild systemic disease, or have severe systemic disease that is not life-threatening.
Body Mass Index (BMI) between 18 and 40 kg/m². BMI is a measure of body fat based on height and weight.
Body weight of 50 kg (about 110 pounds) or more.
Ability to understand and communicate in a Scandinavian language.
Capable of giving signed informed consent, meaning you understand the study and agree to participate.

Who Cannot Join the Study?

Patients with a radius fracture cannot participate. A radius fracture is a break in one of the bones in the forearm.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

Where you can join this trial?

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Norway	Not recruiting	01.12.2024

Trial locations

Investigated drugs:

Ropivacaine is a medication used to numb a specific area of the body to prevent pain during and after surgery. In this trial, it is used to block nerves in the shoulder area to help manage pain after surgery on the wrist. The study is looking at how different strengths of this medication might affect the level of pain patients feel after their surgery. By comparing these strengths, researchers hope to find out if one is better at reducing pain without causing too many side effects.

Investigated diseases:

Radius fracture

Radius fracture – A radius fracture is a break in the radius bone, one of the two large bones in the forearm. This type of fracture often occurs near the wrist and can result from a fall onto an outstretched hand. Initially, the area may become swollen, bruised, and painful, especially when moving the wrist or forearm. As the fracture progresses, there may be visible deformity or an inability to rotate the forearm. Healing involves the formation of new bone tissue, which gradually stabilizes the fracture site. Over time, with proper care, the bone regains strength and function, although stiffness and reduced range of motion can persist for some time.

Trial ID:

2024-514795-41-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Post-Surgery Pain Relief for Radius Fracture Patients Using Ropivacaine and Oxycodone

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