Clinical trial NCT06284941: A Study of Ropivacaine Complex Methylene Blue Fascia Iliaca Compartment Block on Analgesia in Patients Undergoing Hip Arthroplasty
Official title: A Study of Ropivacaine Complex Methylene Blue Fascia Iliaca Compartment Block on Analgesia in Patients Undergoing Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Neck Disease
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Visual Analogue Scale（VAS）
timeFrame: 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 outcomes:
measure: Hypersensitive C-reactive Protein
timeFrame: From enrollment to 48 hours after surgery
measure: Procalcitonin
timeFrame: From enrollment to 48 hours after surgery
measure: Neutrophil Lymphocyte Ratio
timeFrame: From enrollment to 48 hours after surgery
measure: Mean Arterial Pressure
timeFrame: From entering the operating room to leaving the resuscitation room
measure: Heart Rate
timeFrame: From entering the operating room to leaving the resuscitation room
measure: Duration of Surgery
timeFrame: Intraoperative
measure: Number of Postoperative Salvage Analgesia
timeFrame: From the end of surgery to 48 hours after surgery
measure: Walking Distance for the First Time Getting Out of Bed
timeFrame: From the end of surgery to 48 hours after surgery
measure: The Number of Activities of Getting Out of Bed 48 Hours After Surgery
timeFrame: From the end of surgery to 48 hours after surgery
Other outcomes:
Locations:
city: Taizhou
country: China
facility: Jiangyan District Hospital of traditional Chinese medicine attached to the Nanjing University of Chinese Medicine
state: Jiang Su
Study officials:
affiliation: not have
name: Zhang yang
role: STUDY_CHAIR
References: