Femoral Neck DiseaseNCT06284941

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

A study testing Ropivacaine combined with methylene blue for iliac fascia block in people with Femoral Neck Disease, run by Wang wanxia at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 65 to 85 years
Conditions the study is for: Femoral Neck Disease
What is being tested?: Ropivacaine combined with methylene blue for iliac fascia block
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteChina
Study dates: 20 Jun 2023to 28 Feb 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 85 years
All sexes
No healthy volunteers
Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Jiangyan District Hospital of traditional Chinese medicine attached to the Nanjing University of Chinese Medicine
Taizhou, Jiangsu, 225500

Other trials in China

About this study

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.

Conditions: Femoral Neck Disease
Being tested: Ropivacaine combined with methylene blue for iliac fascia block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06284941
Study group	Role	What they receive
0.25% ropivacaine 30ml for iliac fascia block	No intervention	Not described
0.25% ropivacaine+0.05% methylene blue 30ml for iliac fascia block	Experimental	Not described Receives: Drug: Ropivacaine combined with methylene blue for iliac fascia block

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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 (9)

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
Measured: From enrollment to 48 hours after surgery
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
Measured: From enrollment to 48 hours after surgery
Neutrophil Lymphocyte Ratio
Measured: From enrollment to 48 hours after surgery
Mean Arterial Pressure
Measured: From entering the operating room to leaving the resuscitation room
Heart Rate
Measured: From entering the operating room to leaving the resuscitation room
Duration of Surgery
Measured: Intraoperative
Number of Postoperative Salvage Analgesia
Measured: From the end of surgery to 48 hours after surgery
Walking Distance for the First Time Getting Out of Bed
Measured: From the end of surgery to 48 hours after surgery
The Number of Activities of Getting Out of Bed 48 Hours After Surgery
Measured: From the end of surgery to 48 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 202328 Feb 2024

First posted29 Feb 2024
Study start20 Jun 2023
Primary completion28 Feb 2024
Study completion28 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Femoral Neck DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06284941
Sponsor's protocol ID: KY 2023-001-001
Status last verified: Feb 2025
First submitted: 4 Feb 2024
Last updated: 4 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 40087701

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Recruiting
Clinical Outcomes of Primary Cementless Total Hip Arthroplasty Using the Collarless Actis Stem
Osteoarthritis, Hip, Femur Head Necrosis
Recruiting
Bone Marrow Injection in Fracture of Femoral Neck
Bone Marrow, Femoral Neck Fractures
RecruitingObservational study
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System
Total Hip Arthroplasty (THA), Hemiarthroplasty
RecruitingObservational study
Study of Parameters of Osteosarcopenia in Patients With Hip Fracture
Osteoporotic Fracture of Femur, Osteoarthritis, Hip

All Femoral Neck Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Ropivacaine Complex Methylene Blue Fascia Iliaca Compartment Block on Analgesia in Patients Undergoing Hip Arthroplasty
ClinicalTrials.gov ID: NCT06284941
Acronym / sponsor ID: KY 2023-001-001
Conditions: Femoral Neck Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Wang wanxiaUniversity, hospital or other
Study start: 20 Jun 2023 (actual)
Primary completion: 28 Feb 2024 (actual)
Study completion: 28 Feb 2024 (actual)
First posted: 29 Feb 2024 (actual)
Results: Posted 4 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
0.25% ropivacaine 30ml for iliac fascia block	No intervention	–
0.25% ropivacaine+0.05% methylene blue 30ml for iliac fascia block	Experimental	Drug: Ropivacaine combined with methylene blue for iliac fascia block

Who may qualify

Ages: 65 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ropivacaine combined with methylene blue for iliac fascia blockUltrasound guided iliac fascia block, administered with 30ml of 0.25% ropivacaine+0.05% methylene blue	Drug	0.25% ropivacaine+0.05% methylene blue 30ml for iliac fascia block

Primary outcome

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

9 secondary outcomes

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

Results and safety

Results posted to the registry on 4 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
0.25% Ropivacaine 30ml for Iliac Fascia Block	45	45
0.25% Ropivacaine+0.05% Methylene Blue 30ml for Iliac Fascia Block	45	45

Primary outcome: 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. Median (Inter-Quartile Range). Unit: score

Measure	0.25% Ropivacaine 30ml for Iliac Fascia Block n = 45	0.25% Ropivacaine+0.05% Methylene Blue 30ml for Iliac Fascia Block n = 45
Value	3.0 (2.0 to 3.5)	4.0 (4.0 to 5.0)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: The total time for collecting adverse events was approximately 48 hours, each participant was collected from the end of the surgery to 48h postoperatively.. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
0.25% Ropivacaine 30ml for Iliac Fascia Block	0 of 45 (0%)	7 of 45 (15.6%)	0 of 45
0.25% Ropivacaine+0.05% Methylene Blue 30ml for Iliac Fascia Block	0 of 45 (0%)	6 of 45 (13.3%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40087701Zhang 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.

Related trials for Femoral Neck Disease

RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Recruiting
Clinical Outcomes of Primary Cementless Total Hip Arthroplasty Using the Collarless Actis Stem
Osteoarthritis, Hip, Femur Head Necrosis
Recruiting
Bone Marrow Injection in Fracture of Femoral Neck
Bone Marrow, Femoral Neck Fractures
RecruitingObservational study
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System
Total Hip Arthroplasty (THA), Hemiarthroplasty
RecruitingObservational study
Study of Parameters of Osteosarcopenia in Patients With Hip Fracture
Osteoporotic Fracture of Femur, Osteoarthritis, Hip

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zhang yang study chair

not have

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ropivacaine combined with methylene blue for iliac fascia block in people with Femoral Neck Disease, run by Wang wanxia at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06284941, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.