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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

15 criteria

  • 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
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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.

What is already known about the treatment

  • Ropivacain Fresenius Kabi

    This medication is supplied as a clear solution for injection and is applied perineurally, meaning it is injected close to the nerve. Ropivacaine is an approved local anesthetic that is widely used in clinical practice and described in many medical papers. It is mainly used to numb an area for surgery or pain relief, especially in orthopedic procedures. It works by blocking sodium channels in nerve cells, preventing pain signals, and belongs to the amide‑type local anesthetic class.

  • Natriumklorid Fresenius Kabi 9 mg/ml

    This product is a sterile sodium chloride solution for parenteral use and is given perineurally as a harmless fluid. Sodium chloride is an established medical ingredient, listed in all drug references and used as a standard placebo in trials. It has no therapeutic effect of its own but provides a balanced salt solution that matches the body’s fluids. It simply restores normal salt balance and is classified as an isotonic electrolyte solution.

  • Dotarem, injektionsvæske, opløsning i enkeltdosisbeholder. i.v.

    The drug is provided as a sterile solution for injection and is administered perineurally in the study, although it is normally given intravenously for imaging. Gadoteric acid is an approved contrast agent used in magnetic resonance imaging and is well documented in the literature. It is used to improve the visibility of structures during MRI scans, not for treating disease. It works by altering magnetic signals in the body’s water molecules and is classified as a paramagnetic MRI contrast medium.

Investigated diseases

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 detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510388-37-00Protocol codeSIFICBEstimated enrolment20 patientsSponsorRegion Midtjylland

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