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Clinical Trials/NCT06284941
NCT06284941
Completed
Not Applicable

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

Wang wanxia1 site in 1 country90 target enrollmentJune 20, 2023

Overview

Phase
Not Applicable
Intervention
Ropivacaine combined with methylene blue for iliac fascia block
Conditions
Femoral Neck Disease
Sponsor
Wang wanxia
Enrollment
90
Locations
1
Primary Endpoint
Visual Analogue Scale(VAS)
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 20, 2023
End Date
February 28, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Wang wanxia
Responsible Party
Sponsor Investigator
Principal Investigator

Wang wanxia

Principal Investigator

Yangzhou University

Eligibility Criteria

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.

Arms & Interventions

0.25% ropivacaine+0.05% methylene blue 30ml for iliac fascia block

Intervention: Ropivacaine combined with methylene blue for iliac fascia block

Outcomes

Primary Outcomes

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

  • Hypersensitive C-reactive Protein(From enrollment to 48 hours after surgery)
  • Procalcitonin(From enrollment to 48 hours after surgery)
  • Neutrophil Lymphocyte Ratio(From enrollment to 48 hours after surgery)
  • Mean Arterial Pressure(From entering the operating room to leaving the resuscitation room)
  • Heart Rate(From entering the operating room to leaving the resuscitation room)
  • Duration of Surgery(Intraoperative)
  • Number of Postoperative Salvage Analgesia(From the end of surgery to 48 hours after surgery)
  • Walking Distance for the First Time Getting Out of Bed(From the end of surgery to 48 hours after surgery)
  • The Number of Activities of Getting Out of Bed 48 Hours After Surgery(From the end of surgery to 48 hours after surgery)

Study Sites (1)

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