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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.25% ropivacaine 30ml for iliac fascia block | No Intervention | ||
| 0.25% ropivacaine+0.05% methylene blue 30ml for iliac fascia block | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Procalcitonin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhang yang | not have | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangyan District Hospital of traditional Chinese medicine attached to the Nanjing University of Chinese Medicine | Taizhou | Jiangsu | 225500 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40087701 | Derived | Zhang Y, Yang S, Lu ZR, Zhou F, Liu MY. Analgesic effect of ropivacaine combined with methylene blue in fascia Iliaca block for patients undergoing hip arthroplasty. BMC Musculoskelet Disord. 2025 Mar 14;26(1):256. doi: 10.1186/s12891-025-08490-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.25% Ropivacaine 30ml for Iliac Fascia Block | 0.25% ropivacaine 30ml for iliac fascia block |
| FG001 | 0.25% Ropivacaine+0.05% Methylene Blue 30ml for Iliac Fascia Block | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.25% Ropivacaine 30ml for Iliac Fascia Block | Fascia iliaca block with ropivacaine: ultrasound-guided fascia iliaca block, administered with 30ml of 0.25% ropivacaine |
| BG001 | 0.25% Ropivacaine+0.05% Methylene Blue 30ml for Iliac Fascia Block |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | Inter-Quartile Range | score | 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 |
|
The total time for collecting adverse events was approximately 48 hours, each participant was collected from the end of the surgery to 48h postoperatively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.25% Ropivacaine 30ml for Iliac Fascia Block | Fascia iliaca block with ropivacaine: ultrasound-guided fascia iliaca block, administered with 30ml of 0.25% ropivacaine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yang Zhang | Jiangyan District Hospital of traditional Chinese medicine attached to the Nanjing University of Chinese Medicine | 15861013918 | 617405180@qq.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 24, 2024 | Jan 31, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008751 | Methylene Blue |
| ID | Term |
|---|---|
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
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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 |
| 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 |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Jiangyan District Hospital of traditiona |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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 |
|
|
| Secondary | 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 | Not Posted | From enrollment to 48 hours after surgery | Participants |
| Secondary | 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 | Not Posted | From enrollment to 48 hours after surgery | Participants |
| Secondary | Neutrophil Lymphocyte Ratio | Not Posted | From enrollment to 48 hours after surgery | Participants |
| Secondary | Mean Arterial Pressure | Not Posted | From entering the operating room to leaving the resuscitation room | Participants |
| Secondary | Heart Rate | Not Posted | From entering the operating room to leaving the resuscitation room | Participants |
| Secondary | Duration of Surgery | Not Posted | Intraoperative | Participants |
| Secondary | Number of Postoperative Salvage Analgesia | Not Posted | From the end of surgery to 48 hours after surgery | Participants |
| Secondary | Walking Distance for the First Time Getting Out of Bed | Not Posted | From the end of surgery to 48 hours after surgery | Participants |
| Secondary | The Number of Activities of Getting Out of Bed 48 Hours After Surgery | Not Posted | From the end of surgery to 48 hours after surgery | Participants |
| 0 |
| 45 |
| 0 |
| 45 |
| 7 |
| 45 |
| EG001 | 0.25% Ropivacaine+0.05% Methylene Blue 30ml for Iliac Fascia Block | 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 | 0 | 45 | 0 | 45 | 6 | 45 |
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| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |