Study of ropivacaine, sodium chloride and gadoteric acid in nerve blocks for hip pain in healthy volunteers

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What is this study about?

This study focuses on investigating nerve blocks for hip pain management. The research compares two different types of nerve blocks: the subpectineal obturator nerve blockade (SOB) and suprainguinal fascia iliaca compartment block (SIFICB). These procedures involve injecting medications near specific nerves to provide pain relief in the hip area.

The medications used in this study include Ropivacaine, which is a local anesthetic solution for injection, and Dotarem, a contrast agent used for imaging. Sodium chloride solution is also used during the procedure. The purpose of the study is to determine how effectively these nerve blocks can reduce sensation in specific nerves, particularly the obturator nerve.

During the study, participants will receive nerve blocks and undergo various tests to measure the effectiveness of the treatment. These tests include muscle strength measurements and special imaging called MRI to see how the medication spreads in the body. The study will evaluate how well the nerve blocks work by measuring changes in muscle activity and areas of numbness in the skin.

1 Initial nerve block procedure

You will receive one of two types of nerve blocks: either a suprainguinal fascia iliaca compartment block (SIFICB) or a subpectineal obturator nerve blockade (SOB)

The procedure involves an injection of Ropivacain (local anesthetic) and sodium chloride solution in the hip area

The injection will be administered through the skin to target specific nerve areas

2 Muscle response testing

Your muscle responses will be measured using EMG (a test that records electrical signals from muscles)

The test focuses on the gracilis muscle (inner thigh muscle)

Measurements will be taken before and after the nerve block to compare the differences

3 Imaging procedure

You will undergo an MRI scan using Dotarem (contrast agent)

The imaging will show how the medication spreads in the targeted area

This procedure helps to verify the placement and distribution of the nerve block

4 Strength assessment

Your muscle strength will be measured using a special device called a dynamometer

The test will focus on your thigh muscles (adductor and quadriceps)

The measurements will help determine how the nerve block affects muscle function

5 Skin sensation testing

Your skin sensation will be tested in the affected area

The test will determine where the numbness occurs

The size of the numb area will be measured and documented

Who Can Join the Study?

Patient must be 18 years or older
Patient must have a BMI (Body Mass Index) less than 25 kg/m² – BMI is a measure that uses your height and weight to determine if your weight is healthy
Patient must weigh 69 kilograms or more
Patient must be classified as ASA I or II – this means being healthy or having only mild systemic disease according to the American Society of Anesthesiologists classification system
Patient must be able to read and understand Danish
Patient must be able to read, understand and sign the informed consent form
Both male and female participants can join the study

Who Cannot Join the Study?

Body Mass Index (BMI) over 35 (severe obesity)
Known allergies to local anesthetic medications
History of blood clotting disorders or current use of blood thinners
Active infection in the hip or groin area
Previous surgery in the hip region
Neurological conditions affecting the hip or leg
Pregnancy or breastfeeding
Inability to provide informed consent
Current participation in other clinical trials
Chronic pain conditions requiring regular pain medication
Uncontrolled high blood pressure
Severe heart, liver, or kidney disease
History of adverse reactions to medical procedures
Mental health conditions that could affect study participation
Use of medications that could interact with the study procedures

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Region Midtjylland	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.03.2024

Trial locations

Investigated drugs:

Suprainguinal fascia iliaca compartment block (SIFICB) is a type of local anesthetic nerve block technique where medication is injected into a specific anatomical space above the groin area. This technique aims to provide pain relief by blocking several nerves that supply sensation to the hip and thigh region.

Subpectineal obturator nerve block (SOB) is another type of local anesthetic nerve block that specifically targets the obturator nerve, which provides sensation to parts of the thigh and hip joint. The medication is injected near the obturator nerve as it passes through the pectineal muscle.

Note: While the specific local anesthetic medication used in these nerve blocks is not mentioned in the source data, these procedures typically use local anesthetic medications to temporarily block nerve signals in the targeted areas.

Investigated diseases:

Pain in extremity

Hip Pain – A condition characterized by discomfort, aching, or soreness in or around the hip joint. The pain can develop gradually or suddenly, affecting the ability to walk, climb stairs, or perform daily activities. Hip pain may be felt in various areas around the hip joint, including the thigh, groin, or buttocks. The condition can range from mild to severe and may be accompanied by stiffness, reduced range of motion, or weakness in the affected area. Hip pain can affect people of all ages and may result from various underlying causes.

Trial ID:

2023-510388-37-00

Protocol code:

SIFICB

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of ropivacaine, sodium chloride and gadoteric acid in nerve blocks for hip pain in healthy volunteers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?