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Lidocaine

Clinical trials are investigating Lidocaine in several patient groups, including people with frozen shoulder, perineal tears, liver surgery, calcinosis cutis, and pain-related procedures. These studies aim to measure pain relief, function, and treatment response, and they include different trial phases and ages.

Table of contents

Clinical trials overview

The trial data show that Lidocaine is being studied in different clinical settings, not as a general drug description but as part of specific research questions.[1][2] These studies are mainly interventional trials, which means researchers assign a treatment or comparison and then measure the results.[1] The studies are authorised or completed and include Phase 2, Phase 3, and Phase 4 research.[1]

Across the trials, Lidocaine is used in different ways, including intra-articular injection, topical use, intranasal use, infiltration, cutaneous use, and intravenous use.[1] The main research focus is on pain relief, function, recovery, or disease response depending on the condition being studied.[1]

Conditions being studied

One Phase 3 trial studies frozen shoulder and compares physical therapy, corticosteroid injections, and their combination, with Lidocaine included in the injection arm.[2] The main outcome is the Shoulder Pain and Disability Index, which measures pain and how the shoulder problem affects daily life.[2]

Another Phase 3 trial studies first-degree perineal laceration, which means a small tear in the tissue between the vagina and anus after delivery.[3] This study compares topical lidocaine-prilocaine cream with Lidocaine infiltration to see which method gives better pain control during repair and in the two hours after birth.[3]

A Phase 4 trial studies patients with liver tumours who are having liver surgery.[4] In this study, intravenous Lidocaine is tested against sodium chloride, and the main outcome is total opioid use in the first 24 hours after surgery.[4]

Other studies include post-dural puncture syndrome, calcinosis cutis in systemic sclerosis, severe acute trauma-related pain in children, and general pain related to peripheral intravenous cannulation.[5][6][7][8] These trials show that Lidocaine is being tested in both procedure-related pain and more complex medical problems.[5][7]

Who the trials include

The target populations are different in each study, but they are all defined by the condition or procedure under investigation.[1] For example, the trauma pain study focuses on children, while the perineal tear study focuses on women after delivery.[1][3]

The frozen shoulder trial includes patients with shoulder stiffness and pain, and the liver surgery trial includes patients with liver tumours scheduled for surgery.[2][4] The calcinosis cutis study includes patients with systemic sclerosis, a long-term autoimmune disease, who have calcium deposits in the skin and soft tissue.[6]

Some studies compare Lidocaine with another active treatment, while others compare it with a control or standard care approach.[2][4] This helps researchers understand whether the study treatment improves outcomes better than the current approach.[2]

Trial phases and study design

The trial set includes Phase 2, Phase 3, and Phase 4 studies.[1] Phase 2 studies in this set include the severe trauma-related pain trial and the post-dural puncture syndrome trial.[1][5] Phase 3 studies include frozen shoulder, first-degree perineal laceration, calcinosis cutis, and the pain study related to peripheral intravenous cannulation.[2][3][6][7]

The studies are all interventional, meaning the researchers actively assign the treatment being tested.[1] Sample sizes vary from 40 participants to 2,000 participants, showing that some trials are small and focused while others are much larger.[7][1]

Main outcomes and endpoints

The primary outcomes differ by condition, but most are centered on pain, recovery, or disease improvement.[1] In the trauma pain study, the main endpoint is the change in pain intensity on a vertical visual analog scale from the start of treatment to 30 minutes later.[1]

In the frozen shoulder trial, the main outcome is the Shoulder Pain and Disability Index, which captures both pain and function.[2] In the perineal tear trial, the outcome is pain measured with a visual analogue scale during the repair and during the two hours after delivery.[3]

The post-dural puncture syndrome study measures headache intensity in the upright position at several time points, from the start of the intervention up to 7 days later.[5] The liver surgery study measures total opioid consumption in the first 24 hours after surgery, which shows how much additional pain medicine is needed.[4]

The calcinosis cutis trial measures complete and partial remission from week 0 to week 28, using scans and clinical improvement as part of the assessment.[6] The peripheral intravenous cannulation pain study measures pain with a numerical rating scale after use of a 10% Lidocaine spray.[7]

Selected trial details

Frozen shoulder trial. This Phase 3 study plans to enroll 180 people and is authorised.[2] It compares physical therapy, corticosteroid injections, and combined treatment, with pain and function assessed at 3 months.[2]

First-degree perineal tear trial. This Phase 3 study plans to enroll 84 women and compares Lidocaine infiltration with topical lidocaine-prilocaine cream.[3] The study looks at pain during anesthetic administration, during repair, and in the two hours after delivery.[3]

Liver surgery trial. This Phase 4 study has 124 planned participants and is completed.[4] It tests intravenous Lidocaine in patients with liver tumours undergoing surgery and measures opioid use in the first 24 hours.[4]

Post-dural puncture syndrome trial. This Phase 2 study plans to enroll 80 participants and is authorised.[5] It measures headache intensity at several time points after either a sphenopalatine block or a blood patch.[5]

Calcinosis cutis trial. This Phase 3 study plans to enroll 75 participants and is authorised.[6] It measures complete and partial remission over 28 weeks in patients with calcinosis cutis in systemic sclerosis.[6]

Severe acute trauma-related pain trial. This Phase 2 pediatric study plans to enroll 116 children and compares intranasal sufentanil with intranasal ketamine.[1] Lidocaine-related products are listed among the study interventions, and pain is measured with a vertical visual analog scale from baseline to 30 minutes.[1]

Pain from peripheral intravenous cannulation. This Phase 3 study is completed and enrolled 40 participants.[7] It evaluates pain after use of a Lidocaine spray on the hand or forearm area during cannulation.[7]

Key patient-focused points

These trials show that Lidocaine is being studied in many different clinical situations, especially where pain control matters.[1] The research includes children, women after childbirth, surgical patients, and people with chronic or procedure-related pain.[1][3][4]

The endpoints are practical and patient-centered, such as pain scores, movement and function, headache relief, opioid use, and remission of disease findings.[2][4][5][6] Together, the studies aim to see where Lidocaine can help most and how it compares with other treatments or standard care.[2][4]

Trial IDPhaseCondition studiedStatusEnrollment
2024-512728-12-00Phase 3First-degree perineal lacerationAuthorised84
NCT05153785Phase 4Patients with liver tumours that have liver surgery performedCompleted124
2025-522168-34-00Phase 2Post-dural puncture syndromeAuthorised80
2024-519728-26-00Phase 3Frozen shoulderAuthorised180
2023-510255-34-00Phase 3Calcinosis cutis in systemic sclerosisAuthorised75
2023-507859-29-00Phase 3PainCompleted40
NCT06968546Phase 2Severe acute trauma-related painAuthorised116

FAQ

  • What kinds of conditions are being studied with Lidocaine? The trials include frozen shoulder, first-degree perineal tears, liver surgery, calcinosis cutis in systemic sclerosis, post-dural puncture syndrome, and procedure-related pain. Some studies also use Lidocaine as part of pain control during emergency or minor procedures.
  • Who can take part in these Lidocaine trials? Each trial has its own target group. Examples include women with first-degree perineal tears, patients having liver surgery, children with severe trauma-related pain, and people with frozen shoulder or calcinosis cutis.
  • What phases are the Lidocaine studies in? The trials are mainly in Phase 2, Phase 3, and Phase 4. This means they are testing how well the study treatment works, comparing options, or looking at outcomes in real-world patient groups.
  • What outcomes are the trials measuring? The studies measure outcomes such as pain scores, shoulder pain and disability, headache intensity, clinical response, opioid use after surgery, and remission of calcinosis cutis. Some trials also look at safety-related outcomes like kidney injury or treatment exposure.
  • Are all the studies using Lidocaine in the same way? No. The trials use Lidocaine in different ways, such as injection, topical use, intranasal use, intra-articular injection, and intravenous use. The form depends on the condition being studied.

Ongoing Clinical Trials on Lidocaine

  • Comparing intranasal sufentanil and ketamine for severe acute trauma-related pain management in children admitted to pediatric emergency care

    Recruiting

    2 1 1 1
    Investigated drugs:
    France

  • Comparing Sphenopalatine Block Using Lidocaine and Prilocaine to Blood Patch for Patients with Post-Dural Puncture Syndrome

    Recruiting

    2 1 1 1
    Investigated drugs:
    France

  • Study of pivmecillinam compared to standard antibiotics for treating Escherichia coli urinary tract infection with fever

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway Sweden

  • Comparison of Gentamicin with Narrow-Spectrum Antibiotics versus Broad-Spectrum Antibiotics in Adult Patients with Early Sepsis

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway

  • Study on Frozen Shoulder: Evaluating the Effectiveness of Physiotherapy, Triamcinolone Acetonide, and Lidocaine in Improving Shoulder Function and Reducing Pain

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway

  • Comparing Lidocaine-Prilocaine Cream and Lidocaine Injection for First-Degree Perineal Tear Repair in Women

    Recruiting

    3 1 1 1
    Investigated drugs:
    Spain

  • Study on Treating Calcinosis Cutis in Systemic Sclerosis Patients with Sodium Thiosulfate, Cetrimide, and Lidocaine

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study of antibiotic treatment effectiveness in critically ill patients receiving drug combination therapy

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    France

  • Study on Reducing Pain During IV Catheter Insertion in Adult Women Using 10% Lidocaine Spray

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria

  • Study on Lidocaine and Sodium Chloride for Patients Undergoing Liver Tumor Surgery

    Not recruiting

    4 1 1
    Investigated drugs:
    Sweden

Glossary

  • Clinical trial: A research study in people that tests a treatment, procedure, or care strategy.
  • Interventional study: A study where researchers assign a treatment or procedure and then measure the results.
  • Phase 2: An early study phase that checks whether a treatment seems to work and continues to watch safety.
  • Phase 3: A larger study phase that compares treatments and looks more closely at how well they work.
  • Phase 4: A later study phase done after a treatment is already in use, to learn more about its effects in practice.
  • Enrollment: The number of people planned for or included in a study.
  • Primary outcome: The main result the researchers want to measure.
  • Visual Analogue Scale (VAS): A pain scale where people rate pain along a line, often from no pain to worst pain.
  • Numerical Verbal Scale (NVS): A pain scale using numbers, usually from 0 to 10.
  • Shoulder Pain and Disability Index: A questionnaire that measures shoulder pain and how much shoulder problems affect daily life.
  • Remission: A major improvement or disappearance of signs of a disease.

References

  1. https://clinicaltrials.eu/trial/comparing-intranasal-sufentanil-and-ketamine-for-severe-acute-trauma-related-pain-management-in-children-admitted-to-pediatric-emergency-care/
  2. https://clinicaltrials.gov/study/2024-519728-26-00
  3. https://clinicaltrials.gov/study/2024-512728-12-00
  4. https://clinicaltrials.eu/trial/study-on-lidocaine-and-sodium-chloride-for-patients-undergoing-liver-tumor-surgery/
  5. https://clinicaltrials.gov/study/2025-522168-34-00
  6. https://clinicaltrials.gov/study/2023-510255-34-00
  7. https://clinicaltrials.gov/study/2023-507859-29-00
  8. https://clinicaltrials.gov/study/2024-516232-10-00