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Study on Pain Relief in Hip Replacement Surgery Using Ropivacaine and Adrenaline for Patients Undergoing Total Hip Arthroplasty

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What is this trial about?

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

This clinical trial is focused on patients undergoing Total Hip Arthroplasty, commonly known as hip replacement surgery. The study is investigating the effects of a treatment involving two medications: Ropivacaine Hydrochloride and Adrenaline. Ropivacaine Hydrochloride is a local anesthetic, which means it helps numb the area to reduce pain, while Adrenaline is often used to prolong the effects of anesthetics and reduce bleeding.

The purpose of the study is to determine if injecting these medications directly into the hip joint before surgery can reduce the need for additional pain medication after the operation. This is compared to a placebo injection, which does not contain active medication. The study will involve patients receiving their hip replacement surgery and will monitor their need for extra pain relief in the hours and days following the procedure.

Participants in the study will receive either the medication or a placebo before their surgery. The study will track how many patients require additional pain medication after the operation, as well as other factors like pain levels, side effects, and overall satisfaction with the pain management. The goal is to see if this approach can improve pain control and recovery for patients undergoing hip replacement surgery.

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

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose and procedures. You will be asked to provide written consent to participate.

    Eligibility criteria include being over 18 years old, on the waiting list for primary total hip arthroplasty, and willing to participate.

  2. Step 2

    Preoperative preparation

    Before the surgery, you will receive an intra-articular injection in the hip joint. This injection will contain either ropivacaine and adrenaline or a placebo.

    The purpose of this injection is to determine if it reduces the need for additional pain medication after surgery.

  3. Step 3

    Surgery and immediate recovery

    You will undergo total hip arthroplasty, a surgical procedure to replace the hip joint.

    During the first 6 hours after the injection, the use of additional pain medication will be monitored.

  4. Step 4

    Postoperative monitoring

    Your pain levels will be assessed using a numerical rating scale (NRS) during your hospital stay.

    The need for additional pain medication, any side effects, and overall satisfaction will be recorded.

  5. Step 5

    Discharge and follow-up

    Before discharge, the amount of pain medication used and any side effects will be evaluated.

    Your satisfaction with the treatment will be measured using the Net Promoter Score (NPS).

Who can join the trial?

6 criteria

  • Must be over 18 years old.
  • Must be on the waiting list for a primary total hip arthroplasty (THA), which is a type of hip replacement surgery, performed by one of the participating orthopedic surgeons.
  • Must be classified as ASA 1, ASA 2, or ASA 3. This is a system used by doctors to assess the physical health of patients before surgery. ASA 1 means a healthy patient, ASA 2 means a patient with mild systemic disease, and ASA 3 means a patient with severe systemic disease.
  • Must be eligible to receive the full enhanced recovery pain- and anesthetic protocol, which is a plan to help manage pain and recovery after surgery.
  • Must be willing to participate in the study.
  • Must be willing to provide written informed consent, which means agreeing to participate after being fully informed about the study.

Who cannot join the trial?

5 criteria

  • Patients who have had a total hip arthroplasty (a type of hip surgery) before.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who have any medical condition that the study doctors think might make it unsafe for them to participate.
  • Patients who are not able to follow the study procedures or instructions.
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Investigated drugs

  • Ropivacaine

    is a medication used to numb a specific area of the body. In this study, it is injected directly into the hip joint before surgery. The goal is to reduce pain after hip replacement surgery, so patients might need less pain medication afterward.

  • Adrenaline

    , also known as epinephrine, is often used with other medications to help them work better. In this study, it is combined with Ropivacaine to help keep the numbing effect in the hip joint longer. This combination aims to reduce the need for additional pain relief after surgery.

What is already known about the treatment

Ropivacaine – Ropivacaine is administered as an injection directly into the hip joint, a method known as intra-articular infiltration, before hip replacement surgery. It is currently being studied to see if it can reduce the need for additional pain medication after surgery. The main use of Ropivacaine is to manage pain, particularly during and after surgical procedures like total hip arthroplasty. It works by blocking nerve signals in the body, which helps to numb the area and reduce pain. Ropivacaine is classified as a local anesthetic, which means it is used to numb a specific part of the body.

Investigated diseases

Total Hip Arthroplasty – Total Hip Arthroplasty, also known as hip replacement surgery, involves replacing a damaged or worn-out hip joint with an artificial implant. This procedure is typically performed to relieve pain and improve function in individuals with severe hip arthritis or injury. Over time, the natural hip joint may become painful and stiff, limiting mobility and daily activities. During the surgery, the damaged bone and cartilage are removed and replaced with metal, ceramic, or plastic components. Recovery involves a period of rehabilitation to restore strength and movement. The artificial joint is designed to mimic the natural movement of the hip, allowing for improved mobility and reduced pain.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509109-57-01Protocol codeOC-2023-005Estimated enrolment120 patientsSponsorReinier Haga Groep Orthopedisch Centrum B.V.

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