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.

Study Overview

• Status: Completed
• Conditions: Femoral Neck Disease
• Intervention / Treatment: Drug: Ropivacaine combined with methylene blue for iliac fascia block

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiang Su
    • Taizhou, Jiang Su, China, 225500
      • Jiangyan District Hospital of traditional Chinese medicine attached to the Nanjing University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 0.25% ropivacaine 30ml for iliac fascia block
Experimental: 0.25% ropivacaine+0.05% methylene blue 30ml for iliac fascia block	Drug: Ropivacaine combined with methylene blue for iliac fascia block; Ultrasound guided iliac fascia block, administered with 30ml of 0.25% ropivacaine+0.05% methylene blue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale（VAS）	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procalcitonin	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	From enrollment to 48 hours after surgery
Hypersensitive C-reactive Protein	Hypersensitive C-reactive protein, like procalcitonin, is an inflammatory marker. Both have the same meaning and are used to reflect the postoperative analgesic effect	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

Collaborators and Investigators

• Sponsor: Wang wanxia
• Investigators: Study Chair: Zhang yang, not have

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: February 4, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 1, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Ropivacaine; Methylene Blue
• Other Study ID Numbers: KY 2023-001-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No