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Comparing Ropivacaine with Epinephrine Injection Methods for Pain and Bleeding Control in Patients Undergoing Lumbar Fusion Surgery

Verified siteRegistered drugNo placebo
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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 comparing two different methods for controlling pain and bleeding during lumbar fusion surgery, a procedure performed on the lower back to join two or more vertebrae together. The study will evaluate two techniques: Periarticular Vasoconstrictor Infiltration (PIV) and Erector Spinae Plane Block (ESP), which are methods used to reduce blood loss and manage pain during and after surgery.

The medications used in this study include ropivacaine, a local anesthetic that helps control pain, and epinephrine, a medication that helps reduce bleeding. Both medications will be given as injections near the surgical area. The purpose of this research is to determine which of these two methods is more effective in reducing blood loss and controlling pain after spine surgery.

During the study, patients undergoing lumbar fusion surgery will receive either the PIV or ESP treatment. The medical team will monitor the amount of blood loss during surgery and track how well pain is controlled afterward. This research aims to help doctors better understand which method provides better results for patients having this type of back 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

    Initial preparation

    You will be scheduled for a lumbar fusion surgery, which is a procedure to join vertebrae in your lower back.

    The medical team will assign you to one of two pain control methods before the surgery.

  2. Step 2

    Pain control method administration

    You will receive one of these two methods:

    Option 1: Periarticular Vasoconstrictor Infiltration (PIV) - an injection of medication around the joint area

    Option 2: Erector Spinae Plane Block (ESP) - an injection of medication near the spine muscles

    Both methods use ropivacaine (a local anesthetic) and epinephrine (helps control bleeding) as injectable solutions

  3. Step 3

    Surgery procedure

    The surgical team will perform the lumbar fusion procedure

    During surgery, the medical team will monitor and measure blood loss

    The procedure will involve joining up to 3 levels of your spine

  4. Step 4

    Post-surgery monitoring

    The medical team will monitor your pain levels after surgery

    Your recovery progress will be tracked throughout your hospital stay

  5. Step 5

    Study duration

    Your participation in the study will occur during your scheduled surgery and immediate recovery period

    The overall study runs from September 2025 to January 2027

Who can join the trial?

4 criteria

  • You must be a male or female adult who is scheduled for lumbar fusion surgery (a surgery to join together vertebrae in your lower back) involving no more than 3 levels of your spine
  • You must be over 18 years of age
  • You must be able to read, understand, and sign the informed consent form (a document that explains the study details, risks, and benefits)
  • You must be willing to participate in the research comparing two different types of nerve blocks (PIV block and ESP block) used for pain control during and after surgery

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Known allergies to local anesthetics or any medications used in the study
  • Pregnancy or breastfeeding
  • Blood clotting disorders (conditions that affect how blood forms clots)
  • Severe liver disease (conditions affecting liver function)
  • Severe kidney disease (conditions affecting kidney function)
  • Infection at the site of planned injection
  • History of chronic pain requiring regular pain medication
  • Previous spine surgery
  • Mental conditions that may affect ability to provide informed consent
  • Inability to communicate in the required language
  • Body mass index (BMI) greater than 35 (measurement of body fat based on height and weight)
  • Cardiovascular disease (heart and blood vessel conditions)
  • Uncontrolled diabetes (high blood sugar levels)
  • Current use of blood-thinning medications
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Investigated drugs

Vasoconstrictor Periarticular Infiltration (PIV) is a local anesthetic technique where medications that constrict blood vessels are injected around the joints and surgical area. This helps reduce bleeding during surgery and manages pain after the procedure. Erector Spinae Plane (ESP) Block is a regional anesthesia technique where pain medication is injected near the spine muscles. This creates a numbing effect in the back area, helping to control pain during and after surgery. The medication spreads along the back muscles to block pain signals from reaching the brain. Both techniques are used in lumbar fusion surgery to help control bleeding and manage post-surgical pain, but they work in different ways and target different areas around the spine.

What is already known about the treatment

  • Vasoconstrictor (for periarticular infiltration)

    A medication administered through local injection around the joints during lumbar spine surgery to reduce bleeding and control pain. This substance works by constricting blood vessels in the surgical area, which helps minimize blood loss during the procedure and provides post-operative pain relief. The medication belongs to the class of vasoconstrictive agents and is commonly used in orthopedic surgical procedures, particularly in spinal fusion surgeries where blood loss control is crucial.

  • Local Anesthetic (for ESP block)

    A medication used in Erector Spinae Plane (ESP) block, which is injected near the spine to provide regional anesthesia and pain control during and after lumbar fusion surgery. This nerve-blocking agent works by temporarily interrupting pain signals from the surgical site to the brain, targeting the erector spinae muscles and surrounding nerve structures. The medication belongs to the local anesthetic drug class and is administered through precise injection guided by imaging technology to ensure accurate placement and optimal pain management.

Investigated diseases

Lumbar Arthrodesis - A medical condition where two or more vertebrae in the lower back (lumbar spine) are joined together through a surgical fusion process. The condition develops when there is instability, degeneration, or damage to the lumbar spine that requires permanent stabilization. During the natural healing process following surgery, the fused vertebrae gradually grow together to form a single, solid bone. This fusion process typically occurs over several months as the body creates new bone tissue between the vertebrae. The condition affects the normal flexibility of the spine at the fused segments, though this is intentional to provide stability and reduce pain.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521572-56-00Protocol codeIIBSP-IPV-2024-178Estimated enrolment62 patientsSponsorFundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

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