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Completed

NCT Number: NCT06284941

A Study of Ropivacaine Complex Methylene Blue Fascia Iliaca Compartment Block on Analgesia in Patients Undergoing Hip Arthroplasty

Total hip arthroplasty is currently the most effective method for treating hip joint lesions and improving quality of life, but postoperative severe pain is not conducive to rapid recovery of patients. In recent years, the widespread application of ultrasound has achieved good clinical results in iliac fascia block for postoperative analgesia in THA. However, the use of high-dose local anesthetics can increase the risk of local anesthetic poisoning, and the single block analgesia time is generally less than 24 hours. Methylene blue, as a long-acting analgesic drug, can block the pain transmission of nerve fibers for a long time, achieving analgesic effects without damaging neurons. This study used ultrasound-guided ropivacaine combined with methylene blue to perform iliac fascia block on patients undergoing total hip replacement, with the aim of prolonging pain relief time, reducing complications, and promoting postoperative recovery on the basis of traditional methods.

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Key information

Conditions

Femoral Neck Disease

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jiangyan District Hospital of traditional Chinese medicine attached to the Nanjing University of Chinese Medicine

Taizhou, Jiangsu, 225500, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hip replacement surgery is indicated
  • ASA Class II - Class III
  • No history of analgesic or local anesthetic allergy
  • No history of alcohol abuse or narcotic drug abuse
  • Patients and their families have given informed consent and signed the informed consent form

Exclusion criteria

  • Patient or family refusal to participate in the study
  • Severe coagulation abnormalities
  • Local anesthetic allergy
  • Severe psychiatric illness or other communication disorder
  • There is an infection at the puncture site
  • History of neurological disease such as Guillain-Barré syndrome
  • Delay in awakening post-surgery for more than 60 min,
  • Post-surgical use of an analgesic pump
  • Inability to follow-up at the required time points.

Treatment and study plan

Ropivacaine combined with methylene blue for iliac fascia block

Drug

Ultrasound guided iliac fascia block, administered with 30ml of 0.25% ropivacaine+0.05% methylene blue

Primary outcomes

  1. Visual Analogue Scale（VAS）

    Time frame: From enrollment to 48 hours after surgery， the VAS scores at both rest and with activity (passive straight leg raise at 45°) were recorded at the following time points: before block and at 2, 6, 12, 24, and 48 h postoperatively

    Use a swimming ruler about 10 cm long, marked with 10 ticks on one side, and "0" and "10" at each end. A score of 0 indicates no pain, a score of 10 indicates the most severe pain that is unbearable, and the higher the score, the greater the degree of pain

Secondary outcomes

  1. Hypersensitive C-reactive Protein

    Time frame: From enrollment to 48 hours after surgery

    Hypersensitive C-reactive protein, like procalcitonin, is an inflammatory marker. Both have the same meaning and are used to reflect the postoperative analgesic effect

  2. Procalcitonin

    Time frame: From enrollment to 48 hours after surgery

    Procalcitonin is an inflammatory marker, which is associated with postoperative pain, the higher the degree of pain, the higher the procalcitonin value, the lower the pain level, and the lower the procalcitonin value, and the level of procalcitonin is used to reflect the postoperative analgesic effect

  3. Neutrophil Lymphocyte Ratio

    Time frame: From enrollment to 48 hours after surgery

  4. Mean Arterial Pressure

    Time frame: From entering the operating room to leaving the resuscitation room

  5. Heart Rate

    Time frame: From entering the operating room to leaving the resuscitation room

  6. Duration of Surgery

    Time frame: Intraoperative

  7. Number of Postoperative Salvage Analgesia

    Time frame: From the end of surgery to 48 hours after surgery

  8. Walking Distance for the First Time Getting Out of Bed

    Time frame: From the end of surgery to 48 hours after surgery

  9. The Number of Activities of Getting Out of Bed 48 Hours After Surgery

    Time frame: From the end of surgery to 48 hours after surgery

Sponsors and collaborators

Lead sponsor

Wang wanxia

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 29, 2024
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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